Quidel scores FDA nods for Life Tech-powered tests

Quidel won FDA clearance for two tests using Life Technologies' QuantStudio instrument.--Courtesy of Life Technologies

California's Quidel ($QDEL) picked up FDA clearances for two infectious disease tests that run on Life Technologies' ($LIFE) diagnostics platform, and the two companies are partnering up to spread the assays around the globe.

Quidel won a 510(k) nod for its Influenza A+B assay, a molecular test that can determine whether patients have the flu and detect the H7N9 subtype, which the company said carries a nearly 30% mortality rate. Separately, the FDA cleared Quidel's RSV + hMPV assay, which diagnoses respiratory syncytial virus and human metapneumovirus, two lung infections.

Both tests operate on Life's QuantStudio Dx Real-Time PCR instrument, and Life has signed up to co-promote its diagnostic device and Quidel's tests, which are already CE marked in Europe.

"Our partnership with Quidel constitutes a key component of our strategy to expand our presence in the diagnostics space," said Life President of Genetic Analysis and Medical Sciences Ronnie Andrews in a statement. "We will continue to pursue the opportunity to partner to add content to our FDA-cleared systems in key disease areas."

Life touts QuantStudio as its flagship diagnostics instrument, and Life is counting on a deeper dive into high-demand molecular diagnostics to counterbalance some flagging sales in its other businesses. Last quarter, the company watched its revenue slip 1% to $945.8 million, as a 4% drop in genetic analysis sales negated modest gains in research consumables and applied science.

In August, Life's board approved Thermo Fisher's ($TMO) $13.6 billion takeover offer, and the companies expect to seal the deal next year.

- read Quidel's statement

Suggested Articles

BD will begin working with Babson Diagnostics to help bring its lab-quality device for collecting blood from capillaries into retail pharmacies.

The former CEO of the molecular testing company Foundation Medicine, Troy Cox, has been named chairman of the Swiss big data firm Sophia Genetics.

Researchers at MIT used a machine-learning algorithm to uncover the potent antibiotic properties hiding within an old small-molecule candidate.