NICE to evaluate the Genedrive® MT-RNR1 Test under their Diagnostics Assessment Programme
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the UK’s National Institute for Health and Clinical Excellence (‘NICE’) has started an evaluation of the Genedrive® MT-RNR1 test via their Diagnostics Assessment Programme (‘DAP’). DAP evaluations are designed to provide robust recommendations on the use of new products, which is presented in the form of NICE guidance, and to promote rapid and consistent adoption of clinically innovative and cost-effective diagnostic technologies in the NHS.
16th Jun 2022
Point-of-Care Genedrive® COV19-ID Kit receives Coronavirus Test Device Approval (“CTDA”)
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the UK Medicines and Healthcare Products Regulatory Agency has granted a CTDA enabling the sale of the Genedrive® COV19-ID Kit in the United Kingdom. Genedrive’s application for approval, under the requirements that came into force on 28 July 2021 via The Medical Devices (Coronavirus Test Device Approvals Regulations (2021)), was made on 21 December 2021.
30th May 2022
Interim results to 31 December 2021
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces unaudited interim results for the six months to 31 December 2021.
29th Mar 2022
NICE issues Medtech Innovation Briefing on Genedrive ® MT-RNR1 Tes
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the UK’s National Institute of Clinical Excellence (NICE) has today issued a new Medtech Innovation Briefing (MIB) on the Genedrive® MT-RNR1 test. genedrive’s assay is the world’s first point of care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MT-RNR1 test. The Medtech Innovation Briefing is an important step to increase awareness in the NHS of new innovation and ultimately support adoption in the UK.
29th Mar 2022
PALOH study results published in JAMA Pediatrics
Publication confirms Genedrive® MT-RNR1 test’s role in avoiding antibiotic related hearing loss in infants genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the Pharmacogenetics to Avoid Loss of Hearing (“PALOH”) trial, conducted at Manchester and Liverpool Hospitals to assess the implementation of the Genedrive® MT-RNR1 ID kit, has now been published in the Journal of the American Medical Association for Pediatrics (“JAMA Pediatrics”), which is the top ranked medical journal in pediatric medicine.
21st Mar 2022
First NHS Deployments of the Genedrive® System for Antibiotic Induced Hearing Loss
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the first six installations of the Genedrive® MT-RNR1 Antibiotic Induced Hearing Loss (“AIHL”) system have now been deployed to Manchester University NHS Foundation Trust (“MFT”), with four installations for Saint Mary’s Hospital and two at Wythenshawe Hospital (both part of MFT).
18th Mar 2022
genedrive plc (AIM: GDR), the near patient molecular diagnostics company announces the appointment of Russell (“Russ”) Shaw as the Group’s Chief Financial Officer (“CFO”) and a Director of the Company with effect from 7 April 2022.
17th Mar 2022
Update on Point of Care Covid Test
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, provides an update on the progress being made on the Genedrive® COV19-ID kit, its rapid point of care molecular test for Covid-19. The Genedrive® COV19-ID kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without viral extraction. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants.
23rd Feb 2022
UK CTDA application for Point-of-Care Genedrive® COV19-ID kit
Sensitivity and specificity data submitted meets MHRA requirements Performance data supports successful Omicron detection genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that, further to the announcement on 29 November 2021 confirming submission for CE-IVD certification for the Genedrive® COV19-ID Kit, expanded product validation requirements have now been completed and the Company has filed for approval to sell the product in the United Kingdom under the new Coronavirus Test Device Approvals (CTDA) regulations1. CTDA regulations came into effect on 1 Nov 2021 and place specific registration, review and performance requirements on suppliers of COVID-19 diagnostic products into the United Kingdom.
22nd Dec 2021
CE-IVD certification for Point-of-Care Genedrive® COV19-ID kit
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that further to the announcement of 29 November 2021, its rapid point of care Genedrive® COV19-ID Kit has received CE-IVD certification under the European Communities Council Directive 98/79.
8th Dec 2021
Point of Care Genedrive® COV19-ID submitted for CE-IVD certification
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that it has submitted its new rapid Point of Care molecular test for SARS-CoV-2 detection for CE-IVD certification under the European Communities Council Directive 98/79. The Genedrive® COV19-ID kit offers a step change in rapid molecular testing, delivering positive results as quickly as 7.5 minutes and negative results at 17 minutes.
29th Nov 2021
New Genedrive® System receives CE-IVD marking device ready for Antibiotic Induced Hearing Loss launch
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the new generation Genedrive® System platform, which has been developed to support the commercial launch of the Genedrive® MT-RNR1 ID Kit, has now received CE-IVD marking in anticipation of launch into the UK and EU. The Genedrive® MT-RNR1 assay is used to screen for a genetic mutation called m.1555A>G. If a baby carrying the mutation is given the antibiotic gentamicin, a common treatment for bacterial infections, it can cause lifelong deafness. The Genedrive® test allows for the administration of alternative treatments if the mutation is detected, avoiding the life changing impacts and costs of antibiotic induced hearing loss (“AIHL”).
29th Sep 2021
Genedrive® COVID-19 Point of Care device update
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, provides an update on the development of its Genedrive® COV19-ID Kit, a rapid Point of Care (PoC) molecular test for SARS-CoV-2 detection, designed for the Company’s Genedrive® instrument.
1st Jul 2021
Genedrive COVID-19 PCR test approved by Indian regulator
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the Genedrive® 96 SARS-CoV-2 Kit has been formally approved by the Indian Council of Medical Research (“ICMR”). The Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 100% specificity in the performance evaluation conducted by the ICMR. The Company will now commence commercial activities in India through its existing distributor Divoc Health and will also be seeking additional routes to the market.
30th Apr 2021
Excellent performance of Genedrive® HCV ID Kit in large multi-centre study
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces the publication of a large independent multi-centre study evaluating the real-world performance of the Genedrive® HCV ID Kit in low and middle income countries. The study yielded sensitivity specifications of 96.2 - 100%, and specificity specifications of 98.7 - 99.5%, depending on the site or viral load. The results confirm that the Genedrive® HCV ID Kit is effective as intended in the diagnosis of HCV infection in resource limited settings. Importantly, the authors highlight a test fail rate of only 1.6%, showing that the Genedrive® system performs to this high standard even though the system operators in the study had no previous experience in molecular testing.
23rd Apr 2021
Genedrive enters distribution agreement with Mountain Horse Solutions
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that it has entered into an agreement for the distribution of the Company's military pathogen detection assays in the United States with Mountain Horse Solutions (“Mountain Horse”), a military contracting specialist to U.S. Federal, State, and Local Government customers.
9th Mar 2021
Antibiotic Induced Hearing Loss update New clinical guidance in the UK supports assay
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, provides an update on its Antibiotic Induced Hearing Loss (“AIHL”) assay. As announced on the 3 December 2020, an 11 month implementation trial at Manchester University NHS Foundation Trust and and Liverpool Women’s Hospital successfully concluded in November 2020. The results of the study will be published in a peer reviewed journal. The study’s primary outcomes were very positive, showing genedrive’s utility as the world’s first rapid genetic test in an emergency care neonatal setting. In excess of 750 babies were tested and 160 hospital staff were trained to provide rapid testing in this critical care setting.
3rd Mar 2021
First shipments to US of Genedrive® 96 SARS-CoV-2 Kit
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces the first shipments to the United States of its Genedrive® 96 SARS-CoV-2 Kits. Following the Company’s announcement on 28 January 2021 confirming genedrive’s distribution agreement with Beckman Coulter Life Sciences (“Beckman Coulter”), genedrive can confirm that it has completed its commercial and technical training with the Beckman Coulter sales representatives and has now shipped its first 96 SARS-CoV-2 Kits to the USA. This shipment will allow Beckman Coulter to commence initial sales activities and prepare the market for wider commercial rollout. This shipment coincides with the formal launch of the Genedrive® 96 SARS-CoV-2 Kit by Beckman Coulter today.
17th Feb 2021
Distribution agreement with Beckman Coulter Life Sciences for COVID-19 PCR testing
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that it has entered into a distribution agreement with Beckman Coulter Life Sciences (“Beckman Coulter”) for its Genedrive® 96 SARS-CoV-2 Kit. The agreement enables Beckman Coulter to sell and distribute genedrive’s high-throughput COVID-19 PCR Kit in the United States and Europe for use on upper respiratory viral samples. The agreement is the result of the collaboration agreement announced in August 2020, under which the companies worked to develop and validate a fully automated PCR process for Beckman Coulter’s Biomek automated workstation in conjunction with its RNAdvance Viral XP extraction kit.
28th Jan 2021
Genedrive notifies FDA of its intent to distribute the SARS-CoV-2 PCR test in the USA
Genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that it notified the Food and Drug Association (FDA) in the United States of its intention to import and distribute its Genedrive 96 SARS-CoV-2 Kit prior to an Emergency Use Authorization (EUA) determination, as described in the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.
16th Dec 2020
Antibiotic Induced Hearing Loss assay hospital trial completion
Genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces the successful completion of the Antibiotic Induced Hearing Loss (“AIHL”) implementation study into the use of the genetic test in an NHS neonatal intensive care setting.
3rd Dec 2020
Genedrive® HCV ID Kit demonstrates high clinical accuracy in India Study
Genedrive plc (AIM:GDR), the near patient molecular diagnostics company, announces the publication of the study data for the ‘Evaluation of the Point of Care Molecular Diagnostic Genedrive HCV ID Kit for the detection of HCV RNA in clinical samples’.
20th Nov 2020
Point-of-care solution to detect SARS-CoV-2 in saliva
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces it has completed the assay design for the Company’s Point-of-Care (“POC”) solution for COVID-19 testing and is now generating very promising analytical data aligned to market requirements.
22nd Oct 2020
Genedrive® 96 SARS-CoV-2 Kit approved in South Africa
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that the Company’s Genedrive® 96 SARS-CoV-2 Kit has received approval from the South African Health Products Regulatory Authority. The Genedrive® kit was submitted for evaluation in June 2020.
30th Sep 2020
Genedrive® 96 SARS-CoV-2 Kit verified with Beckman Coulter Life Sciences RNA extraction chemistry
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that the Company has completed initial testing of Beckman Coulter Life Sciences’ RNAdvance Viral RNA extraction chemistry on respiratory swabs in conjunction with its COVID-19 PCR test. The sensitivity in using the Genedrive Kit with samples from upper respiratory swabs is equivalent to the existing Genedrive SARS-CoV-2 Kit specification claim, indicating the Beckman product is suitable for use in the Genedrive testing workflow. The Beckman RNAdvance kit has now been added to the Genedrive 96 SARS-CoV2 Instruction for Use as a validated extraction protocol for swabs. This is an important technical milestone in transitioning the Genedrive® 96 SARS-CoV-2 Kit to a fully automated workflow using Beckman’s RNA extraction and Biomek automated workstation.
25th Sep 2020
Genedrive and Beckman Coulter collaborate to automate high throughput SARS-CoV-2 PCR testing
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that it has entered into a collaboration with Beckman Coulter Life Science (Beckman Coulter) to fully automate the overall laboratory PCR testing process for COVID-19. The Companies are working to combine and validate the Genedrive® 96 SARS-CoV-2 Kit on the Biomek i7 automated workstation with samples extracted using Beckman Coulter’s RNAdvance viral extraction chemistry.
4th Aug 2020
New Genedrive 96 Exporter Software
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that it has developed and now CE marked Genedrive® 96 Exporter, a new IVD software module for automated results interpretation of the Genedrive® 96 SARS-CoV-2 Kit.
10th Jul 2020
Trading Updates June 2020
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, provides an unaudited trading update for the 12 months ended 30 June 2020 and an update on regulatory and commercial progress relating to the Genedrive® 96 SARS-CoV-2 Kit ("CoV-2 Test").
10th Jul 2020
Genedrive® 96 SARS-CoV-2 Kit receives CE-IVD Mark
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that the Genedrive® 96 SARSCoV- 2 Kit is now CE-IVD marked and is available for commercial sale across the European Union, including the UK, whilst also accelerating market access to countries that accept the CE-IVD mark.
22nd May 2020
Genedrive® HCV-ID test receives WHO Prequalification
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces it has received World Health Organisation (WHO) Prequalification for the Genedrive® HCV ID kit. This represents the first Genedrive product to have received prequalification status, and the Genedrive HCV ID kit is the first portable point of need HCV device to have received WHO PQ.
4th May 2020
Manufacturing milestones achieved for SARS-CoV-2 test
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces it has completed the last significant manufacturing milestone in the co-development of the Genedrive® 96 SARS-CoV-2 kit with Cytiva. The PCR-based test has completed its pilot manufacturing runs and yielded high performing multiplexed assays for COVID-19 testing. The overall project plan currently remains on track and the company is targeting CE marking in approximately 3 weeks’ time.
1st May 2020
Distribution agreement for AIHL test with Inspiration Healthcare
Inspiration Healthcare Group plc (AIM: IHC), the global medical technology company, is pleased to announce that it has entered into a contract with genedrive plc (AIM: GDR), the near patient molecular diagnostics company, to distribute its Antibiotic Induced Hearing Loss test (Genedrive® MT-RNR1) in the UK and Ireland. It is expected that the scope of the contract between genedrive and Inspiration Healthcare will be expanded over time to engage Inspiration Healthcare’s specialty network of over 50 neonatal focussed sub-distributors around the world.
24th Apr 2020
Genedrive and Cytiva (formerly GE Healthcare Life Sciences) collaborate on Coronavirus
Genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces it has entered into an agreement with Cytiva (formerly GE Healthcare Life Sciences) for the development of its Genedrive® 96 SARS-CoV-2 assay for use on lab-based PCR instruments. This is one of two assay programmes the Company is developing following an announcement made on 25 March 2020.
20th Apr 2020
‘Business Update and Rapid Development of Coronavirus (SARS-COV-2) tests
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, provides an update on trading in the current market conditions and a redirection in assay development focus to include Coronavirus (SARS-COV-2).
26th Mar 2020
MT-RNR1 test receives CE Marking
We are thrilled to announce that the Genedrive MT-RNR1 ID kit, has obtained CE marking. The Genedrive MT-RNR1 ID kit will be used in critical care settings to screen babies for a genetic mutation, which if present, can cause lifelong deafness when they are given certain antibiotics.
18th Nov 2019
AbbVie sponsored REACH study for the use of Genedrive HCV assay in pharmacies
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that it will participate in an international multicentre trial (‘REACH’) to assess the impact of out-reach HCV diagnostics and therapy in a pharmacy setting versus conventional treatment pathways. The study, led by Prof. John Dillon, Professor of Hepatology and Gastroenterology at the University of Dundee and funded by AbbVie will cover up to 40 pharmacies across three sites in Scotland, Wales, and Australia.
29th Nov 2018
genedrive to release Genedrive® Connect mobile app
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces phase 1 development of its Genedrive® connectivity solution, allowing for clinical data transmission from decentralised testing facilities. The new app is designed to enhance usability, but also provide functional surveillance-based data to further promote product adoption in the longer term.
2nd Oct 2018
Genedrive Partners With Find To Evaluate A Molecular Diagnostic Kit For Hepatitis C Virus In Decentralised Settings
genedrive plc and the Foundation for Innovation of New Diagnostics (FIND), announced today a study agreement for the performance evaluation of genedrive plc’s hepatitis C virus (HCV) Genedrive® HCV ID Kit. The Genedrive® HCV ID Kit is a qualitative HCV diagnostic assay, performed on the company’s portable molecular diagnostics platform, Genedrive®. The assay is designed for use in low-resource settings, and delivers results in 90 minutes.
8th Aug 2018
Grant to develop and implement a point-of-care test in the NHS to avoid antibiotic-related hearing loss in newborn children
genedrive plc, the near patient molecular diagnostics company, today announces its receipt of a multi-partner grant award from the UK National Institute for Health Research’s Invention for Innovation programme, for the development and implementation of a point-of-care pharmacogenetic test to avoid antibiotic-related hearing loss in newborn children.
20th Jun 2018
Completion of Disposal
Further to the announcement on 14th May 2018 and shareholder approval at the General Meeting on 4th June, genedrive plc is pleased to announce that it has now completed the sale of its contract research and pharmacogenomics divisions for an aggregate cash consideration of up to £1.9m.
12th Jun 2018
Proposed disposal of the Company’s contract research and pharmacogenomics divisions for up to £1.9 million in cash
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, is pleased to announce that is has entered into a conditional agreement to sell the Group’s contract research and pharmacogenomics divisions for an aggregate cash consideration of up to £1,900,000 (the "Disposal”).
15th May 2018
genedrive plc to Present at the UK Investor Show
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that David Budd, CEO and Matthew Fowler, CFO, will be attending the UK Investor Show, Britain's largest one day investor event.
18th Apr 2018
Publication of Genedrive® Hepatitis C Test Performance Data in BMJ Gut
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces the publication of analytical performance and field evaluation studies of its Genedrive® HCV ID Kit in Europe and Africa in the prestigious BMJ Gut, a leading international journal in gastroenterology and hepatology . The paper is available to view online at: gut.bmj.com/content/gutjnl/early/2018/04/03/gutjnl-2017-315783.full.pdf
10th Apr 2018
genedrive appoints Tom Lindsay as Non-Executive Director
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that it has appointed Tom Lindsay as a Non-Executive Director with immediate effect.
9th Apr 2018
genedrive to premier its Genedrive® Hepatitis C test in Asia Pacific
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces it will premiere its Genedrive® HCV ID Kit in the Asia Pacific region at the MEDLAB Asia Pacific Exhibition & Congress in Singapore on 2-4 April 2018.
3rd Apr 2018
genedrive signs distribution agreement for India with ARKRAY Healthcare pvt Ltd for Genedrive® HCV ID Kit and Genedrive® platform
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that it has signed a distribution agreement with ARKRAY Healthcare pvt Ltd (“ARKRAY”), a wholly owned subsidiary of leading IVD company ARKRAY Inc. Japan, for its CE marked Genedrive® HCV ID Kit and Genedrive® platform in India. Under the agreement, genedrive will retain responsibility for product development, quality management and manufacturing, and ARKRAY will be responsible for sales, marketing, customer support and distribution activities across the region. Working together, the companies will initially focus on securing the required regulatory approvals in India for the Genedrive® HCV ID Kit. genedrive anticipates commercial activities to subsequently commence during the latter part of its 2018/19 financial year.
27th Mar 2018
Commercial sales of Genedrive® HCV ID Kit and platform begin
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that is has commenced commercial sales and shipments of its Genedrive® HCV ID Kit and Genedrive® platform into the EMEA region. The products have been shipped to genedrive’s distributor, Sysmex Corporation (“Sysmex”), a world leader in clinical laboratory systemization and solutions, and are now destined for use in various initial target countries. In addition, first commercial sales and shipments of the Genedrive® HCV ID Kit and Genedrive® platform are expected to commence in the Asia Pacific region in the coming weeks.
13th Mar 2018
genedrive Receives Significant Funding for TB Test Development
genedrive plc, the near patient molecular diagnostics company, today announces that it has been awarded £1.1M in funding (subject to standard approvals) by Innovate UK for product development of its Genedrive® mTB/RIF test. The grant will be used for the further development of a high-sensitivity bacterial sample preparation module for the Genedrive® instrument. genedrive will account for the funding as income, matched to costs incurred over the periods to 30 June 2018 and 2019. Funding is subject to standard approval post award notification.
28th Feb 2018
First Successful Field Evaluation of Genedrive® HCV Assay in Africa
genedrive plc, (AIM: GDR), the near patient molecular diagnostics company, today announces successful results of the first field study of its Genedrive® Hepatitis C (HCV) ID Kit in Africa. The study, performed in Johannesburg at Lancet Laboratories, one of the leading private pathology testing laboratories operating throughout Africa, was designed to verify genedrive HCV’s assay performace across the diverse genotypes which are prevalent in Africa compared to Europe. In a cohort of 130 clinical samples from South Africa, Kenya, Ghana, Nigeria, Uganda, and other Sub-Saharan countries, the Genedrive® HCV ID Kit demonstrated sensitivity and specificity of 100% compared to the Abbott M2000 HCV Real time assay as a reference. The cohort was composed mostly of HCV genotypes 1a, 4, and 1b, with the remaining 16% samples from genotypes 2, 3, and 5. The test also demonstrated efficiency of 95.4% (result achieved first attempt).
16th Jan 2018
genedrive plc awarded £600,000 Innovate UK grant
genedrive plc, the near patient molecular diagnostics company, today announces it has now been formally awarded an Innovate UK grant for the development of a disposable centrifuge-free plasma separation consumable device. In its preliminary results issued in October, genedrive confirmed it had been conditionally offered this grant. The device is planned to support the future use of genedrive’s HCV ID Kit closer to a point of care setting. genedrive plc and its collaborators, NHS Tayside and the Univeristy of Dundee, will receive circa £600,000 of which genedrive will account for its £484,000 share of the funding as income, matched to costs incurred over the periods to 30 June 2018 and 2019.
21st Nov 2017
genedrive signs distribution agreement with Sysmex Asia Pacific Pte Ltd for HCV
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that it has signed a distribution agreement with Sysmex Asia Pacific Pte Ltd, a subsidiary of Sysmex Corporation, for its CE-marked Genedrive® HCV ID Kit and Genedrive® platform in the Asia Pacific region. This is the second agreement signed with a subsidiary of Sysmex Corporation, a world leader in clinical laboratory systemization and solutions, and follows the announcement on 16th October 2017 of a distribution agreement for the EMEA region with Sysmex Europe GmbH.
14th Nov 2017
Update on Distribution arrangements for India / SAARC
genedrive plc (LSE:GDR), the molecular diagnostics company, today provides an update on its distribution arrangements in India / SAARC (“the Territory”). As previously announced, commercialisation of the MTB/RIF tuberculosis tests in India has been challenging for some time. Initially genedrive encountered a specific sample preparation problem which was subsequently identified to stem from a supplier component specific to the MTB/RIF test. The corrective action had been successfully tested initially in Indian reference laboratories however we have experienced difficulties assessing the impact of this through our commercial partner Xcleris Labs Limited (“Xcelris”).
2nd Nov 2017
genedrive launches Genedrive® Hepatitis C test in Africa
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, will launch the decentralised Hepatitis C assay, Genedrive® HCV ID Kit, at the IFCC WorldLab 2017 Congress from 22 - 25 October 2017 in Durban, South Africa.
23rd Oct 2017
genedrive signs distribution agreement with Sysmex Europe GmbH("Sysmex Europe")
genedrive plc (AIM: GDR), the near patient molecular diagnostics company, today announces that it has signed a distribution agreement with Sysmex Europe GmbH, a subsidiary of Sysmex Corporation, a world leader in clinical laboratory systemization and solutions, for the Genedrive® HCV ID Kit and Genedrive® platform in the EMEA region with an initial focus on Africa. genedrive and Sysmex Europe anticipate commercialisation beginning in the coming months targeting end users in decentralised laboratories in multiple countries in Africa, with the rest of the EMEA region to follow.
16th Oct 2017
Genedrive® HCV ID Kit received CE-IVD Certification
genedrive plc (LSE:GDR), the molecular diagnostics company, today announces that the Company has achieved CE certification under the EU Medical Devices Directive for its Genedrive® HCV ID Kit, a qualitative molecular assay for Hepatitis C (HCV). CE marking allows for introduction of the assay into Europe as well as low and middle income countries that accept CE certification under their national regulations. In other countries, CE marking can be a necessary prerequisite to begin local registration processes and is an important endorsement for potential distribution partners.
11th Sep 2017
genedrive plc Awarded Additional $1.4m Funding by US Department of Defense to Continue Development of Genedrive® as a Handheld Biohazard Identifier
genedrive plc, the near patient molecular diagnostics company, is pleased to announce an additional $1.4 million funding award for the continuation of the US Department of Defense (DoD) programme which commenced in August 2015. This follows successful field study trials on the single cartridge solution as initially announced in January 2017.
27th Jul 2017
Hepatitis C Assay performance data accepted for presentation at the International Liver Conference (EASL), April 19-23 in Amsterdam
genedrive plc, the molecular diagnostics company, will be showcasing its molecular Genedrive® HCV ID Kit and Genedrive® platform at the International Liver Conference taking place in Amsterdam from 19th-23rd April 2017. Clinical validation data for Genedrive® HCV ID Kit will be presented at the meeting by Dr Darragh Duffy from the Institut Pasteur, Paris.
11th Apr 2017
Genedrive® HCV Assay submitted for CE IVD Certification
Significant Step in Commercialisation of HCV Assay for Decentralised Use in Resource Limited Settings
27th Mar 2017
Successful Clinical Results for Genedrive® HCV Assay
External Validation Studies Show Sensitivity of Greater Than 99% and Specificity of 100% for Hepatitis C Assay Designed for Decentralised Use in Resource Limited Settings
8th Mar 2017
Delivery of Genedrive® Units and Assays to the US Department of Defense
genedrive plc today announces it has supplied Genedrive® units and assays to the United States Department of Defense (DoD) for field trials as part its $7.8m development programme for a handheld device to allow for the detection of biohazards.
16th Jan 2017
Notice of Preminary Results
Genedrive plc (LSE: GDR), the near patient molecular diagnostics company, is pleased to announce that it will release its preliminary results for the twelve months ending 30 June 2016 on 11 October, 2016.
21st Sep 2016
Board Change: Appointment of Chief Financial Officer
Genedrive plc (LSE: GDR), the near patient molecular diagnostics company, today announces that Matthew Fowler has agreed to become the Company’s Chief Financial Officer and a Director to the Board.
21st Sep 2016
Epistem announces funding from US Department of Defense
Epistem Holdings Plc (LSE: EHP), the molecular diagnostics, personalised medicine and biotechnology company, announces today that the US Department of Defense has awarded $2.9m in funding for the next phase of Epistem's programme to develop a handheld Genedrive® test for biohazard identification.
21st Mar 2016
Epistem Announces Successful External Assessment of Genedrive® Hepatitis C Test at the Institut Pasteur and Commencement of Clinical Studies
Epistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, announces today that its Genedrive® point of care Hepatitis C (“HCV”) test has successfully completed its first external assessment. The assessment was conducted on reference material and patient samples at the Institut Pasteur, Paris, and its success allows clinical trials of the HCV test to commence, in anticipation of regulatory approval and market launch in the EU during 2017.
18th Feb 2016
Epistem announces the appointment of David Budd as new Chief Executive Officer
Epistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, is pleased to announce the appointment of David Budd as Chief Executive Officer and as a Director of Epistem. David will join Epistem by the middle of April 2016.
13th Jan 2016
U.S. Department of Defense to Fund Research at Indiana University and Epistem UK Investigating Treatments for Radiation Sickness
Epistem and Indiana University today announced that they have received funding from the U.S. Department of Defense to evaluate the effects of pegylated hematopoietic growth factors on the mitigation of the hematopoietic and gastrointestinal acute and delayed radiation syndromes.
11th Nov 2015
Indian approval of import licence for Genedrive® TB molecular diagnostic test
Epistem announces today that the Drug Controller General of India (DCGI), Ministry of Health and Family Welfare, Government of India has issued an import licence to its Indian distribution partner, Xcelris Labs, for the import of Epistem’s tuberculosis (TB) and antibiotic resistance test.
23rd Apr 2015
Epistem and CRT Announce Agreement for the Use of Patient Derived Leukemic Samples
Epistem is pleased to announce the signing of a licensing agreement with Cancer Research Technologies (CRT) and Newcastle University for access to and development of patient derived Acute Lymphoblastic Leukemia (ALL) Primagraft samples for commercial use.
21st Apr 2015
Epistem announces the successful evaluation of new RNA-Amp™ (RNA-amplification) technology
Epistem announces today the successful evaluation of its RNA-Amp™ technology for single cell expression profiling. The independently published results compared the Epistem technology with three competitor RNA-Amplification products and showed that Epistem’s RNA-Amp™ technology exhibited the highest sensitivity and reproducibility.
12th Feb 2015
Epistem announces collaborative agreement with Global Health Investment Fund I, LLC.
Epistem is pleased to announce today that it has entered into a collaborative funding agreement with the Global Health Investment Fund I, LLC (GHIF) to support the roll-out of its Genedrive
22nd Jul 2014
Epistem announces the successful demonstration of the Genedrive
Epistem announces today the successful presentation and demonstration of the Genedrive
6th May 2014
Epistem announces further partnership with The University of Manchester
Epistem announce a further partnership with The University of Manchester to further the understanding of the biology of chronic delayed wound healing associated with skin ulcers.
22nd Apr 2014
Epistem announces installation of UK's first Bruker Xtreme Imaging system
Marketwire: Epistem Holdings Plc (LSE: EHP), Manchester, UK, the biotechnology and personalized medicine company, today announced the successful installation of the Bruker Xtreme Imaging System within its contract research services division. This is the first such machine in the UK and will enable Epistem to expand both the range and throughput of its imaging services, particularly in the field of oncology. The Bruker Xtreme provides high sensitivity luminescence, fluorescence, radio-isotopic and radiographic (X-ray) imaging. Combined with Epistem's specialized pre-clinical knowledge this increases the range of assays the company can provide to its clients as well as their ability to identify new targets for cancer therapy.
4th Apr 2014
Epistem announces opening of US laboratory
Epistem Holdings Plc (LSE: EHP), Manchester, UK, the biotechnology and personalised medicine company, today announced that it has opened a US laboratory based in Baltimore, Maryland. The laboratory will support the expansion of Epistem's contract research division within the US. The US laboratory is currently offering histology and immunohistochemistry (IHC) services to a range of US clients, expanding upon the success of the GcLP and GLP compliant UK laboratory. The experienced and skilled technical team have already developed IHC protocols for a panel of over 150 antibodies which are available to clients worldwide.
4th Mar 2014
Epistem announces evaluation of Genedrive
Epistem announces today a cooperative agreement with the US Air Force alongside an agreement with Johns Hopkins University - Advanced Physics Laboratory, to undertake the combat (in field use) evaluation of Epistem
18th Dec 2013
EPISTEM RECEIVES A PRESTIGIOUS FP7 GRANT AWARD FOR THE DEVELOPMENT OF POINT OF CARE HEPATITIS C ASSAYS
Epistem is pleased to announce that it has been awarded funding of
8th Aug 2013
Epistem co-presents biomarker data at the ASCO 2013 Annual Meeting
Epistem today announced that it has co-authored a poster reporting biomarker data that will be presented at the American Society of Clinical Oncology Annual Meeting,
28th May 2013
UK-Norwegian collaboration aims to develop a new living skin equivalent testing model for testing inflammatory responses.
Epistem and ScandiDerma, a Norwegian company with expertise in developing new dermatological ingredients from biomass, today announced that they aim to develop a new in vitro human living skin equivalent model for testing inflammatory responses.
20th May 2013
Epistem presents biomarker data, and its new preclinical model of acute myeloid leukaemia, at the AACR 2013 Annual Meeting
Epistem today announced it will be presenting advances in two independent research platforms at the American Association for Cancer Research Annual Meeting in Washington DC on Tuesday 9th April. Dr Gino Mele, Operations Director of Epistem
8th Apr 2013
Epistem has announced today that their Contract Research Division
19th Feb 2013
Announcement of TB partnership with Becton Dickinson for the Supply and Distribution of Genedrive
Epistem has announced that it has reached agreement with Becton Dickinson (BD) for the supply and distribution of itsMycobacterium tuberculosis (TB) test on a global basis (excluding India and the Indian Sub Continent) using its Genedrive
7th Aug 2012
Epistem Tuberculosis test gains CE-IVD registration
Epistem is pleased to announce the registration of its rapid molecular test for Tuberculosis (TB) test as a CE Marked in vitro diagnostic medical device (CE-IVD).
9th Jul 2012
EPISTEM ANNOUNCES A THREE YEAR COLLABORATION WITH GLAXOSMITHKLINE IN FIBROSIS RESEARCH
Epistem is pleased to announce a three year biomarker collaboration with GlaxoSmithKline in the field of fibrosis research. The collaboration will focus on identifying key characteristics of diseased fibrotic tissue on which Epistem will apply its proprietary RNA-Amp
13th Mar 2012
Epistem signs Tuberculosis channel partner agreement
Epistem is pleased to announce today the signing of a sales and marketing agreement for its rapid molecular test for Tuberculosis (TB) with Xcelris Labs, one of India
5th Mar 2012
Epistem announces partnership with The University of Manchester
Epistem announce a partnership with Dr Matthew Hardman at The University of Manchester in which novel preclinical models for cutaneous wound healing, developed within Dr Hardman?s laboratory, will be transferred to Epistem.
10th Nov 2011
Human Deoxyribonucleic Acid (DNA) Identification Collaboration
Epistem is pleased to announce today the formation of a human DNA Identification collaboration with the National Policing Improvement Agency (NPIA). Epistem and the NPIA will be evaluating Epistem
5th Oct 2011
Epistem is pleased to announce today the successful completion of its first round Tuberculosis (TB) clinical studies as part of its diagnostic collaboration with Xcelris Laboratories, one of India
27th Sep 2011
Tuberculosis diagnostic collaboration
Epistem is pleased to announce today the formation of a Tuberculosis (TB) diagnostic collaboration with Xcelris Laboratories, one of India
28th Jun 2011
Epistem announces collaboration with sanofi-aventis
Epistem today announced a collaboration with sanofi-aventis U.S. Inc. relating to the use of Epistem's proprietary biomarker gene expression profiling and immunohistochemistry technologies.
17th Mar 2011
Epistem presents its new ex vivo plucked hair biomarker assay at EORTC-NCI-AACR symposium
Epistem today announced presentation of its novel ex vivo plucked hair biomarker assay at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium in Berlin on Friday 19th November. Epistem has developed a method for maintaining plucked human hairs ex vivo, and then treating with therapeutic agents to obtain valuable information on the cellular response to drug treatment.
18th Nov 2010
EPISTEM AWARDED FURTHER LONG TERM FUNDING FOR NIH BIODEFENCE PROGRAMME
Epistem announced today that it has been reappointed for up to five years to provide preclinical testing services as a subcontractor to the U.S. National Institutes of Health
3rd Nov 2010
Epistem to present data from their model of Crohn
Epistem will present preclinical results from its recently completed colitis study at the Inflammation Research Association (IRA) conference in Chantilly, Virginia USA between 26-29th September 2010.
20th Sep 2010
EPISTEM ANNOUNCE AGENCY AGREEMENT WITH VERITAS JAPAN
Epistem announced today that its Contract Research Services division has entered into an agreement with the Veritas Corporation to exclusively market and distribute Epistem
2nd Sep 2010
Epistem has announced today that their Biomarker Division has been awarded Good Clinical Laboratory Practice (GCLP) accreditation status. The Biomarker Division conducts gene expression analysis to support clinical drug development programs within pharmaceutical and biotechnology organisations, with an increasing focus on providing valuable biomarker information that can be used in diagnostic applications.
7th Jun 2010
EPISTEM TO LAUNCH RNA-AMP
Epistem will launch their RNA-Amp
16th Apr 2010
EPISTEM TO PRESENT HUMAN PLUCKED HAIR LABELLING PLATFORM AT AACR MEETING IN WASHINGTON DC
Epistem will present details of their new plucked hair immunohistochemistry platform at the American Association for Cancer Research Annual Meeting in Washington DC on Tuesday 20th April. Epistem have developed immunohistochemical labelling and imaging techniques for individual plucked human scalp hairs to monitor direct cellular response to drug treatment. The data to be presented at the conference confirms that this is a valuable technique for inclusion in clinical biomarker programmes.
14th Apr 2010
National Institutes of Health's National Institute for Allergy and Infectious Diseases Initiates Second Study of AEOL 10150 as a Medical Countermeasure for GI Acute Radiation Syndrome
Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board: AOLS) announced today that a second study of its lead drug, AEOL 10150, has been initiated by the National Institutes of Health's (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Radiation/Nuclear Medical Countermeasures development program as a countermeasure for radiation exposure to the gastrointestinal (GI) tract. This study, funded by NIAID, is designed to test the efficacy of AEOL 10150, as measured by survival advantage, as a treatment for damage to the GI tract due to exposure to radiation. If effective, additional studies could be funded to optimize dose and duration of delivery, and to evaluate the window of opportunity for treatment after exposure
29th Mar 2010
EPISTEM WINS UK TRADE AND INVESTMENT AWARD
Epistem received the UKTI's 'Internationalise Your Business' award at the recent Genesis 2009 biotechnology conference in London.
10th Dec 2009
Epistem presents GenetRx
Epistem will present results from two recently completed clinical studies. The first study, with a leading pharmaceutical company, demonstrates androgen receptor pathway activity in hair from elderly volunteers. In the second phase I study, novel pharmacodynamic markers for Enzon Pharmaceuticals Inc
9th Nov 2009
Aeolus Drug Protects the Gastrointestinal Tract in Acute Radiation Syndrome Studies Sponsored by the National Institutes of Health
Aeolus Pharmaceuticals, Inc. announced today that recent experiments in preclinical models conducted by the National Institutes of Health
22nd Oct 2009
Epistem will open a US office based in Boston, MA to increase its presence in the all important North American Market.
19th Oct 2009
Epistem obtient l'accréditation au Crédit d'Impôt Recherche par le gouvernement français
Epistem plc, l'entreprise anglaise de biotechnologie et de contrats de service annonce aujourd'hui son accr
18th Jun 2009
Epistem presents further data supporting its plucked hair biomarker technology at the Institute of Cancer Research Centenary Conference
Epistem will present preclinical results from its recently completed plucked hair biomarker study at the Institute of Cancer Research Centenary Conference, in Queen Elizabeth II Conference Centre, London, UK on 8th to 10th June 2009.
2nd Jun 2009
EPISTEM PRESENT AT AACR MEETING IN DENVER
Epistem have presented results from their latest plucked hair biomarker study at the AACR Meeting in Denver, Colorado on Sunday 19th April. The study was to determine the specific response to oral administration of Erlotinib, the epidermal growth factor receptor (EGFR) inhibitor, in a plucked hair preclinical model. The data itself is impressive and endorses the utility of the plucked hair model.
20th Apr 2009
Epistem to present Erlotinib Biomarker Data at AACR Meeting
Epistem will present results from its recently completed preclinical plucked hair biomarker study at the American Association for Cancer Research (AACR) 100th Annual Meeting in Denver, Colorado on Sunday 19th April 2009 at 1pm (abstract number 1753) This study was completed successfully on Erlotinib, commonly known as Tarceva
14th Apr 2009
EPISTEM ANNOUNCES RESEARCH AND DEVELOPMENT COLLABORATION WITH A MAJOR PHARMACEUTICAL COMPANY
Epistem announced today that they have signed a research and development collaboration with Novartis to identify new drug targets and therapeutics across a variety of disease areas.
2nd Mar 2009
Epistem to Present Plucked Hair Biomarker Data at ASCO-NCI-EORTC Meeting
Epistem will present results from their latest plucked hair biomarker study at the ASCO-NCI-EORTC Meeting on Molecular Markers in Cancer, Hollywood FL, United States on Friday 31st October 2008.
27th Oct 2008
EPISTEM TO PRESENT MINIMALLY INVASIVE ONCOLOGY BIOMARKER DATA AT AACR MEETING
Epistem will present preclinical results from its recently completed plucked hair biomarker study at the American Association for Cancer Research (AACR).
22nd Sep 2008
EPISTEM AND ROTTAPHARM ANNOUNCE POSITIVE RESULTS
Epistem and Rottapharm|Madaus, the multinational pharmaceutical company today announced that favourable results have been obtained with the prophylactic use of CR 3294 in a series of preclinical models for intestinal mucositis.
1st Sep 2008
Epistem selected by Humanetics Corp to provide specialised preclinical efficacy testing services
Epistem announced today that it has been selected by Humanetics Corporation of Minnesota, USA, to provide specialised preclinical efficacy testing services for agents likely to protect the intestinal epithelium from subsequent radiation damage.
24th Jul 2008
EPISTEM TO PRESENT DETAILS OF ITS PROGRAMME WITH US NIH FOR THE SCREENING OF NOVEL AGENTS FOR BIODEFENCE APPLICATIONS AT MASCC SYMPOSIUM
Epistem plc announced today that details of its US National Institute of Health
23rd Jun 2008
EPISTEM TO RELEASE DATA ON ITS CANCER STEM CELL ASSAYS AT AACR
Epistem announced today that data on its cancer stem cell assays will be presented at the international meeting of the American Association for Cancer Research (AACR)
7th Apr 2008
EPISTEM TO PROVIDE PRECLINICAL EFFICACY TESTING SERVICES FOR EXPONENTIAL BIOTHERAPIES
Epistem announced today that Exponential Biotherapies, Inc (EBI). of Virginia, USA, have contracted Epistem to provide their specialised preclinical efficacy testing services for agents likely to protect the gastrointestinal tract against radiation damage.
3rd Apr 2008
EPISTEM PLC AND ASTRAZENECA COMPLETE PLUCKED HAIR BIOMARKER STUDY FOR ONCOLOGY DRUG DEVELOPMENT
Epistem announced today that it had successfully completed a preliminary study with AstraZeneca for the use of its proprietary, minimally invasive plucked human hair biomarker technology to help steer oncology drug development.
28th Jan 2008
EPISTEM HOLDINGS PLC - ISSUE OF EQUITY
Epistem Holdings Plc announced today that it has raised
20th Nov 2007
AACR Conference Used to Present Epistem's Plucked Hair Biomarker
Epistem announced today that data on its plucked hair biomarker platform will be presented at the joint international meeting of the American Association for Cancer Research (AACR), National Cancer Institute (NCI) and European Organisation for Research and Treatment of Cancer (EORTC) being held in San Francisco, California, from October 22nd -26th 2007.
25th Oct 2007
EpiStem Successfully Complete First Year Of Mucositis Tests For NIH Biodefence Programme
Epistem announced today that it has completed the first year of mucositis efficacy-testing services for potential biodefense drugs, and are about to embark upon an extensive drug screening programme over the coming year.
20th Sep 2007
EpiStem Plc announce biomarker studies for new drug development with AstraZeneca
EpiStem announced today that it had entered into feasibility studies with AstraZeneca to use its proprietary plucked hair biomarker technology to help guide preclinical and clinical development of new cancer drugs.
22nd May 2007
EpiStem to be admitted to AIM;
EpiStem Holdings Plc. Fundraising and Placing by Teather and Greenwood 2.5m of new Ordinary Shares at 124 pence per share
4th Apr 2007
EpiStem Ltd announced today that it has been selected to provide in vivo efficacy testing services for the U.S. National Institutes of Health
13th Nov 2006
EpiStem signs agreement with Eden Biodesign to manufacture 250 candidate therapeutic proteins
Epistem announced today that it has entered into a contract manufacturing agreement with Eden Biodesign (Liverpool, UK), a leading provider of support and manufacturing services for the pharmaceutical research industry.
24th Oct 2006
Unique partnership that will help develop new drug to treat mucositis in cancer patients
Japanese firm Kyowa Hakko Kogyo is pioneering new treatment for the prevention of mucositis, a painful condition associated with the treatment of cancer, thanks to Manchester based company EpiStem Ltd.
19th Jun 2006
Applied Imaging Completes First Custom Installation of Ariol(R) Image Analysis System at Preclinical Research Provider EpiStem, Ltd.
Applied Imaging Corp. today announced the successful installation of one of its customized Ariol(R) SL-50 automated imaging systems at EpiStem Ltd., an independent contract research company focused on preclinical epithelial tissue analysis.
31st May 2006
Callisto Pharmaceuticals selects EpiStem to provide specialised preclinical efficacy testing for Guanilib, its lead drug candidate for IBD.
EpiStem Ltd announced today that it has been selected by Callisto Pharmaceutials, Inc to provide specialised preclinical efficacy testing in the area of inflammatory bowel disease (IBD). EpiStem's sophisticated IBD services, called IBDQUANT
15th May 2006
EpiStem Well Placed to Move Forward in 2006
Epistem moves into 2006 with a much strengthened balance sheet following a private equity placing of GBP1.72 and the recognition by its peers of the leading edge technology platform for extracting and using adult epithelial stem cells for diagnostic and therapeutic purposes.
22nd Dec 2005
Leading Adult Stem Cell Company Recognised at Northwest Biotechnology Awards
EpiStem was recognised as the Biotechnology Company of the Year at the recent Northwest Biotechnology Awards organised by the Northwest Regional Development Agency (NWDA). The award sponsored by AstraZeneca, was given to EpiStem against very stiff competition from other established biotechnology companies in the Northwest region.
22nd Nov 2005
Private Placing by Zeus Capital raises
Epistem announces that it has raised
24th Oct 2005