By GREGORY ZELLER //
One of Long Island’s most progressive biotechs has COVID-19’s frightening new variant dead in its sights.
Stony Brook-based Applied DNA Sciences has announced a “diagnostic strategy” in response to Omicron, a newly identified “variant of concern” spun from the nefarious SARS-CoV-2 virus – and it’s wasting no time executing that strategy.
With New York State Department of Health validation expected “in the next few days,” the company said Tuesday it was gearing up to release the Linea 2.0 COVID-19 Assay, a next-generation detection platform that builds on Applied DNA’s established line of COVID-19 diagnostic tools.
The company, which made its name as a DNA-based supply-chain authenticator, has grown into a leading supplier of unique DNA strands to global researchers and trusted manufacturer of polymerase chain reaction-focused technologies.
With Linea 2.0, Applied DNA aims to sniff out Omicron, which is potentially more contagious – and possibly more dangerous – than previous COVID variants, according to the World Health Organization.
James Hayward: Saw this coming.
Originally detected in Botswana, where it reportedly spread among fully vaccinated patients, Omicron has now moved across Africa and been discovered also in Australia, Europe and Canada – and it’s coming soon to the United States, according to domestic scientists.
Applied DNA’s Linea COVID-19 Assay Kit – now known as Linea 1.0 – provides real-time detection of nucleic acid from SARS-CoV-2 in respiratory specimens gathered by nasal swabs and other common means.
Linea 1.0 also exhibits what Applied DNA called a “unique double S-gene target failure” specific to the Omicron variant. While other assays have found similar S-gene mutations shared by several SARS-CoV-2 lineages, the unique double S-gene target failure detected by Linea 1.0 is exclusive to Omicron – creating a “high-specificity reflex test” for the new variant, according to Applied DNA.
With its Linea 2.0 validation testing complete, and the Stony Brook company intends to submit its validation data to the NYS Department of Health this week – and, assuming all goes well, release the new assay shortly thereafter.
It can’t happen fast enough. Health experts were already predicting a COVID resurgence this winter, and while the first U.S. case of the Omicron variant has not yet been detected (as of Tuesday afternoon), President Joe Biden has already announced that his administration is working on Omicron contingency plans – including new national campaigns extolling vaccinations and booster shots, as well as potential collaborations with pharmaceutical companies on new vaccines.
The clock is definitely ticking. But Applied DNA actually had a running start on Linea 2.0, according to President and CEO James Hayward, who noted “the potential need to evolve the Linea 1.0 Assay was anticipated.”
“The Linea 1.0 Assay … brought high specificity, high sensitivity and rapid time to results for population-scale testing,” the CEO said Tuesday. “We (will) continue to service our clients with the Linea 1.0 Assay unless or until health officials indicate the presence of Omicron in our operating area, at which point we will transition to the Linea 2.0 Assay to provide seamless testing services to our customers.
“Viruses evolve – it is their nature,” Hayward added. “While viruses may evolve, ours is an unwavering commitment to providing gold-standard PCR-testing to meet the need for COVID-19 testing.”
