By GREGORY ZELLER //
With the novel coronavirus reestablishing its national dominance, the New York State Department of Health has wasted no time greenlighting a Long Island biotech’s next-generation COVID-detection platform.
Stony Brook-based Applied DNA Sciences announced this week that subsidiary Applied DNA Clinical Labs, a 2020 spinoff dedicated to the commercial development of virology and oncology tests, has received conditional NYS Health Department approval for its Linea 2.0 Assay, designed specifically to detect COVID-19 in individual and pooled samples – including the new and rapidly spreading Omicron variant.
Applied DNA first announced development of its Linea 2.0 COVID-19 Assay in November as a “diagnostic strategy” in response to the then-emerging variant.
James Hayward: Expansion plan.
The platform, which can rapidly sniff out the SARS-CoV-2 virus in individuals or pooled samples from up to five individuals, builds upon previous COVID diagnostic tools created by the Stony Brook-based biotech, Applied DNA first made its name as a DNA-based supply-chain authenticator and has grown into both a leading supplier of unique, research-ready DNA strands and a trusted manufacturer of polymerase chain reaction-focused technologies.
With the Health Department’s conditional approval, the biotech can immediately employ the Linea 2.0 Assay to provide COVID-19 testing in support of safeCircle, a fully integrated enterprise testing platform Applied DNA currently offers to New York State-based clients.
The company is also submitting an Emergency Use Authorization request to the U.S. Food and Drug Administration. If authorized, the EUA would open the Linea 2.0 Assay – and other safeCircle services – to clients beyond the current New York operating area, Applied DNA said in a statement.
An evolution of the company’s successful Linea 1.0 Assay, which ruled the roost before Omicron, the Linea 2.0 Assay is a “three-target, multiplexed, real-time reverse transcription polymerase chain reaction” assay targeting “conserved regions of the SARS-CoV-2 envelope,” according to the biotech.
In short, it senses Omicron – thereby outperforming the Linea 1.0 Assay and allowing Applied DNA “to leverage its proven laboratory workflows to provide rapid and cost-effective testing” that covers the dangerous variant, the company added.
With Omicron “driving single-day COVID-19 cases to record levels almost daily,” Applied DNA is grateful to the NYS Health Department for its conditional approval – and eager to expand its Linea 2.0 playing field, according to President and CEO James Hayward.
“With our ability to support current and prospective New York State-based clients’ testing needs secured, we set our sights on national testing needs and opportunities for population-scale testing,” Hayward said, adding that greater access to PCR-based testing with turnaround times of less than 48 hours – combined with various digital-health tools – “makes safeCircle a timely, accurate and convenient COVID-19 testing platform.”
