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GeneMe, Biolyph Partner to Ramp Up Capacity of COVID-19 MDx

NEW YORK - Biotech firm GeneMe announced on Thursday a partnership with lyophilization services provider Biolyph to support the of scaling up GeneMe's rapid isothermal molecular point-of-care COVID-19 assay.

Financial and other terms of the deal were not disclosed.

The assay — which Gdańsk, Poland-based GeneMe calls FRANKD — detects SARS-CoV-2 virus in 30 minutes directly from patient samples using a real-time isothermal amplification that relies on a patented enzyme formulation. Specifically, the test utilizes GeneMe's patented DNA polymerase fused with NeqSSB protein and fluorescent dye detection.

An assessment by the National Health Service in the UK last month showed the test had an analytical sensitivity of 20 copies per milliliter, according to documents on the firm's website, and GeneMe said the test has 100 percent specificity and 97 percent sensitivity.

The partnership with Biolyph will use that firm's lyophilization production, expertise, and capacity to expand the lifecycle of the FRANKD test, "providing years of room-temperature stability for its patented enzyme," GeneMe said.

The FRANKD test, paired with a reporting software platform called Yoti, is currently being used to test Virgin Atlantic pilots and cabin crew of certain routes departing Heathrow Airport.

GeneMe also provides polymorphism analysis and genetic tests, and the firm is now intensifying its focus on global scale testing services, it said, developing diagnostic kits for the detection of SARS-CoV-2 as well as more than 240 other pathogens.