Shares of Manchester-based molecular diagnostics company Genedrive soared more than 280% on Wednesday after it issued a trading update saying it has “refocussed a significant part of its core resources towards development of two SARS-COV-2 tests.”
Genedrive said in a stock exchange statement it anticipates that a “clinically validated high throughput test format” could be available in eight weeks.
On its coronavirus test development, Genedrive said: “With a rapid global shift of healthcare emphasis towards testing and treatment of COVID-19, the company has refocussed a significant part of its core resources towards development of two SARS-COV-2 tests.
“The company’s first assay, already in development, is an instrument-agnostic molecular assay (the Genedrive 96 SARS-COV-2 test) that can be performed on a variety of high throughput molecular testing platforms already installed in many laboratories around the world.
“The test will determine if a patient has an active SARS-COV-2 infection.
“The company anticipates that a clinically validated high throughput test format could be available in approximately eight weeks.
“The Genedrive 96 SARS-COV-2 test is designed as a one-step, ready-to-go freeze dried assay.
“Based on discussions with sizable third party suppliers the company expects it could have the ability to ramp quickly to high production volumes of over 10,000 tests per hour, and thus this could be both a material revenue generator for the company and significant contributor to addressing the global pandemic.
“Freeze dried assays require no refrigeration and are stable in transport, which is a significant logistical advantage for rapid shipment and global distribution.
“A second test will also be developed by the company where it will adapt its formulations to run on the Genedrive instrument platform to provide a rapid point-of-care SARS-COV-2 test to allow testing outside of the main hospital environment in places such as clinics, intensive care units, or where rapid and accurate testing for SARS-COV-2 might be required.
“The rationale for the two-stage development is that the testing, logistics, validation, and trial work to provide testing on a turnkey instrument system like Genedrive takes additional time compared to an agnostic assay format.
“The company believes that the principal risks on SARS-COV-2 assays development are related to business continuity and supply chain robustness for raw materials in the market, as opposed to technical challenges.
“The company is also actively seeking development partners, distributors and non-dilutive funding to support the most rapid development possible.”
Genedrive CEO David Budd said:”It is a critical time for our industry’s expertise to contribute towards testing and treatment of the Coronavirus pandemic.
“Our novel experience in developing molecular assays, the rapid workflows we can achieve with Genedrive compared to centralised testing, and our scalable manufacturing capability give the company an opportunity to contribute very significantly to the global crisis.
“Given the continued uncertainty and focus of healthcare providers on COVID-19, we expect to experience some disruption to our HCV and AIHL activities but are focused on managing our resources over the coming months so that we can benefit from these growth opportunities when global priorities normalise.”