Official Press Release
Through a synergistic partnership, GeneMe’s coveted FRANKD test will be scaled up through BIOLYPH’s unique lyophilization process, producing more than a million tests before the end of 2020
Gdańsk, Poland, January 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.”
GeneMe is a Polish biotech company, producing services related to polymorphisms analysis and broadly defined genetic tests. The company’s goal is to offer and promote the utility of genetic testing products through the application of advanced scientific technologies in everyday life. Backed by advisory firm Nex.D, GeneMe is intensifying its focus onto new global scale testing services, developing diagnostic kits for the detection of SARS-CoV-2 and more than 240 other pathogens. GeneMe has conducted more than 40 tests with the European Certificate including FRANKD. For more information, visit https://frankd.geneme.eu/
Established in 1993, BIOLYPH proudly serves Life Science, IVD, and RUO reagent manufacturers by converting unstable proteins, antibodies, enzymes, immunochemistry reagents, clinical chemistry reagents, and cells into stable LyoSpheres™. Precise aliquots of lyophilized reagents may be packaged inside virtually any device. BIOLYPH’s LyoSphere™ technology and innovative lyophilization services provide years of room temperature stability, freedom from cold chain dependency, reduced user time, steps and errors, superior ease of use, and maximized quality and performance. BIOLYPH has demonstrated the viability of its robust and relevant technology by processing and packaging hundreds of millions of LyoSpheres™. For more information, visit www.biolyph.com.
Nex.D is a dynamic advisory firm that serves clients across the education, bioTech, deepTech and media markets within the global economy. The company helps clients capitalize on opportunities and solve challenges through the dual-practice platform: investment banking services built on a foundation of strategy development and operating experience, and strategy consulting services built on a foundation of transactional experience and data-based market insight. These two complementary practices are relentlessly focused on one singular outcome: the clients’ optimal path forward. For more information, visit https://nexd.xyz/
Dawid Nidzworski- GeneMe PhD Eng Chief Executive Officer
Sabina Żołędowska - GeneMe PhD Chief Quality Officer
Kasjan Szemiako - GeneMe PhD Chief Technology Officer