Gdańsk, Poland, April, 2021 – GeneMe, the leading biotech company operating in the field of genetic laboratory diagnostics, partners with U.S.-based BIOLYPH, the world leader in lyophilization services. BIOLYPH efficiently, effectively, and economically provides the highest quality and capacity required to enable a significant scaling up of GeneMe’s COVID-19 swab test FRANKD. The partnership represents a ramping up of GeneMe’s test-production capacity to service governments and institutions across the globe, and comes on the heels of a recent partnership with Virgin Atlantic, which implemented the protocol at Heathrow airport in August.

There’s just no getting around it: COVID-19 isn’t going away and the world remains in dire need of more accessible testing that doesn’t compromise on accuracy. A large part of the challenge to produce accurate and efficient RT-PCR COVID-19 testing at a mass scale is providing a test that doesn’t require cold-chain storage, such as the recent Pfizer vaccine that needs to be kept at -70C. GeneMe answered that call by providing a single-step freeze dried test that can be stored at room temperature and shipped anywhere in the world.  

Through this partnership, GeneMe harnesses BIOLYPH’s lyophilization production, expertise, and capacity to expand the lifecycle of its test, providing years of room-temperature stability for its patented enzyme. By supercharging testing volumes, GeneMe’s solution can proactively screen for COVID-19 at the population level, packing FRANKD with much more potency than any other test on the market. 

Using an isothermal reaction test that allows for the detection of nucleic acids, FRANKD’s protocol enables scalable on-premise testing that delivers full results in just 30 minutes, all while minimizing false positives and negatives. It doesn’t require standard thermocycler conditions with different temperatures and can be conducted in one temperature setting, allowing for virus RNA detection through a fluorescent dye. The fusion of patented DNA polymerase with NeqSSB protein allows GeneMe to produce enzymes that significantly refine the testing process, enabling analysis to be specific and scalable for mass use. 

Businesses that run warehouses or manufacturing plants, for instance, will be able to manageably test employees prior to the start of their shifts. Testing machines are simple, small, and can be easily installed on premise. Those tested on-site receive results directly to their phone, so as to not infect anyone unknowingly thereafter. Providing test results in 30 minutes with 100 percent specificity and 97 percent sensitivity surpassing lab-based tests, FRANKD’s solution has already helped large companies such as Virgin Atlantic. It became the first airline in the UK to introduce pre-flight COVID-19 testing; initially starting with flights between Shanghai and Hong Kong, the airline extended its services to Barbados in late October.

Currently, pharmaceutical and testing products that are labile are freeze dried (lyophilized) to maintain their stability and potency. This is where BIOLYPH has completely redefined the lyophilization paradigm, converting manufacturers’ unstable reagents into stable LyoSpheres™. This has expanded the realm of possibilities for reagents, cocktails, and devices. BIOLYPH’s processing expertise optimizes the production and packaging of LyoSpheres without jeopardizing the stable environment in which they are processed. 

“FRANKD has already demonstrated its efficacy, but it’s exciting to now be able to significantly step up its provision,” says Colin Brown, Founder of Nex.D. “BIOLYPH is helping us spread FRANKD’s capabilities to a point where we can make a substantial positive difference during this challenging time for humanity.”

“To be part of an effort contributing towards optimizing the quality of vital COVID-19 testing for the general public and providing production capacity is our core competency,’ says Timothy Pearcy, Founder and CEO of BIOLYPH. “I’m positively impressed with GeneMe and look forward to helping FRANKD achieve its potential.”