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

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