Applied DNA ups ante, again, with Clinical Labs spinoff

This is a test: Applied DNA Sciences can now do its own clinical testing, perchance to speed up regulatory approvals of new COVID-19 tests and other potential breakthroughs.
By GREGORY ZELLER //

One of Long Island’s busiest biotechs has spun off another local startup, this time focused on testing its own potential breakthroughs.

Stony Brook-based Applied DNA Sciences, which has quickly evolved from an upstart DNA-based supply-chain authenticator to a leader in unique DNA manufacturing, has launched Applied DNA Clinical Labs LLC, a wholly owned subsidiary dedicated to the commercial development of two key verticals: Applied DNA’s virology tests, designed to quickly detect COVID-19, and its oncology tests, designed to sniff out invading cancer cells.

The startup, announced Thursday by Applied DNA President and CEO James Hayward, follows the successful 2018 launch of LineaRX, an Applied DNA subsidiary built to capitalize on the parent company’s growing expertise in manufacturing one-of-a-kind DNA chains.

Through LineaRX, Applied DNA has become an integral global supplier of unique, research-ready DNA strands, produced via the Polymerase Chain Reaction technology the parent gained with its 2015 acquisition of West Virginia-based Vandalia Research.

Hayward: DIY clinical testing for Applied DNA.

Applied DNA Clinical Labs also plays nicely with Vitatex Inc., a private biotech with close ties to Stony Brook University – and a patented method of isolating Invasive Circulating Tumor Cells in standard blood samples – acquired by LineaRx last summer.

And the spinoff furthers a strategy that expands Applied DNA’s market reach through value-added services, the same pattern the stalwart defender of supply chains (across numerous high-ticket industries) followed with LineaRx. In this case, Applied DNA is enhancing its market penetration by giving itself the ability to develop new test assays faster and better than the other guys.

But, most importantly, Applied DNA Clinical Labs “allows Applied DNA to be a direct beneficiary of its own diagnostics development, beyond the sales of kits to qualified laboratories,” the parent company said Thursday.

That includes the “clinical sampling framework” necessary for quick state and federal regulatory approvals – big news, the company noted, “in the face of a pandemic with rapidly shifting genetics and infectious behavior.”

Such a scenario played out in May, when Applied DNA received Emergency Use Authorization from the FDA covering a proprietary molecular test for the novel coronavirus that causes COVID-19.

The assay kit, a real-time “qualitative detection” test based on LineaRX’s PCR tech, offers a “high-throughput solution” for laboratories in a coronavirus crunch. It’s still evolving – Applied DNA anticipates a series of EUA amendments that will permit automation of certain functions, increasing throughput and accuracy.

But the novel coronavirus is also evolving, and along with it the need for new and better COVID-19 weapons, according to Hayward, who notes “the demand for COVID testing is diverse” and believes the arrival of Applied DNA Clinical Labs adds some much-needed momentum.

“The new subsidiary was formed to enable clinical testing of patient specimens using methods developed by the company’s research team,” Hayward said. “Access to clinical specimens will also facilitate more rapid development of improvements and new assays.

“All of these continuous improvements are designed to help drive sales to other approved testing labs.”