Genedrive close to hitting the market with coronavirus tests
- Genedrive overcomes technical hurdles with COVID-19 diagnostic kit
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- Genedrive’s inclusion in a Public Health England framework pact positive for future revenues, says broker
- Genedrive target US and Europe with Beckman Coulter for Covid-19 testing technology
Quick facts: genedrive PLC
Price: 25.2975 GBX
Market Cap: £16.02 m
About the company
genedrive PLC is a molecular diagnostics company developing and commercialising a low cost, rapid, versatile, simple to use and robust point of need molecular diagnostics platform for the diagnosis of infectious diseases and for use in patient stratification (genotyping), pathogen detection and other indications.
The company has assays on market for the detection of HCV, certain military biological targets, and has tests in development for tuberculosis (mTB).
genedrive has also released a high throughput SARS-CoV-2 assay.
How it is doing
The kit has been in development for more than nine months, which is a longer period than the company would have liked, which it ascribed to “significant technical hurdles” but it has used that time to make improvements to the performance specifications.
The kit, which will initially be launched in Europe, detects the presence of SARS-CoV-2 virus, including the Delta variant, in a nasal swab. The product has been designed to provide an ease of use appropriate for people inexperienced in molecular testing. Positive samples are detected as quickly as nine minutes, with a negative result reported after 20 minutes if no signal is detected.
The testing procedure does not require extraction of the virus from the patient's sample. The company has developed a proprietary lysis (decomposition) buffer that is used to resuspend patient swab material while providing biosafety to users. The exact quantification of biosafety is currently being assessed in an independent UK Public Health England laboratory, genedrive said. A fully biosafe process would present additional or new opportunities and use-cases for point-of-care (PoC) COVID-19 testing.
The four-step workflow uses an 'eye-dropper' liquid transfer process familiar from lateral flow testing and makes the system appropriate for use by those without previous molecular experience.
genedrive PLC (LON:GDR) shares surged on Friday after the diagnostics firm confirmed it has received a licence to import its COVID-19 testing kit into India through its partner DIVOC Health.
The AIM-listed firm said the licence follows approval of the product by the Indian Centre for Medical Research on April 30.
genedrive PLC (LON:GDR) said its COVID-19 PCR test has been approved by the Indian regulator after it achieved 100% sensitivity and specificity in a performance evaluation conducted by the country’s Council of Medical Research.
The plan is to begin “commercial activities” through its existing local distributor Divoc Health, the company said, adding it will also be “seeking additional routes to the market”.
Insight: Are small-cap biotech stocks good investments now?
Lockdown has seen a long-overdue revival in the fortunes of and interest in the UK’s innovative small-cap life sciences companies with some eye-catching movements.
Genedrive PLC (LON:GDR), HemoGenyx Pharmaceuticals PLC (LON:HEMO), Omega Diagnostics Group PLC (LON:ODX) and OKYO Pharma Ltd (LON:OKYO) stand out with rises of between 600% and 1,100% over that 20-week period.
What the brokers say
“Whilst this is an early indication on future, potential contracts, we consider it a very positive development towards future revenues,” the broker said, retaining its ‘buy’ recommendation.
The framework allows Public Health England, as the sole buyer, to issue call-off orders for products and services for an estimated four-year period, up to a combined value of £3bn, it noted, although it added that about 112 suppliers had been successful.
What management says
genedrive and Beckman Coulter have accelerated their relationship as the duo are to target the US and Europe with their coronavirus testing technology.
The agreement allows the American biomedical company to sell and distribute genedrive's COVID-19 PCR test, the 96 SARS-CoV-2 kit which is ideally suited for use on Beckman’s high throughput robotic Biomek i7 instrument.
Interim results for the six months to December 2017: HepC test launch just started, disposal of services business within reach.
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