Dx Digest: FDA signs off on Luminex's genital herpes tests; Roche's Ariosa takes prenatal Dx to Australia

Welcome to the inaugural Dx Digest, where FierceMedicalDevices will highlight the highs and sometimes lows of the past week in the testing industry. This week, Luminex ($LMNX) made some strides with an FDA nod for its HSV tests. Archrivals Quest ($DGX) and LabCorp ($LH) both struck agreements with Bristol-Myers Squibb ($BMY) to provide companion diagnostic tests for the company's immunotherapy drug, Opdivo, which recently scored another lung cancer indication. Roche ($RHHBY) also had a busy week, with its Ariosa Diagnostics unit expanding the reach for its prenatal test in Australia and the U.K. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)

Luminex nabs FDA OK for herpes test

Luminex got an FDA blessing for its Aries HSV 1&2 tests, continuing a winning streak months after implementing a series of cost-cutting measures to revive revenues. The company's HSV-1 test screens for orally transmitted viruses, while its HSV-2 test pinpoints sexually transmitted infections that cause genital herpes. Austin, TX-based Luminex expects that the system's launch will expand its potential market to cover 6,500 labs, a 13-fold jump over its current customer base in the U.S., CEO Homi Shamir said in a statement. Statement

Quest and LabCorp strike lung cancer companion Dx deals with Bristol-Myers Squibb

Quest last week announced that it would offer a clinical lab test for Bristol-Myers Squibb's Opdivo for nonsquamous non-small cell lung cancer (NSCLC) after the FDA approved the drug to treat the disease in individuals whose cancer has spread and who have already received treatment. The test looks for a PD-L1 biomarker to see if patients are a good fit for the med.

A few days later, LabCorp revealed its own deal with BMS, saying it would provide a new companion diagnostic test for PD-L1 in patients with previously treated NSCLC who participate in clinical trials. The test is not required for Opdivo, but offers more information to doctors about how patients' survival odds could improve while taking the med, LabCorp said in a statement.

A companion diagnostics deal also comes about a year after LabCorp struck a $6 billion deal for contract drug development company Covance ($CVD) in a bid to diversify and ease its financial woes. "The launch of this innovative assay reinforces the importance of the LabCorp-Covance combination," LabCorp CEO David King said in a statement. "We remain committed to our three strategic priorities: bringing innovative medicines to patients, using information to change the way care is delivered, and providing world-class diagnostic information." Statement | Release | More

Ariosa Diagnostics expands prenatal testing in Australia, U.K.

Roche has been hard at work broadening the reach for Ariosa Diagnostics' Harmony prenatal test since acquiring the company last December. Now, Ariosa is teaming up with an Australian outfit to provide its diagnostic at the company's labs in Australia and the U.K. Both sides are staying quiet on financial details, but the deal supports Ariosa's goal of bolstering the test's international presence, the company said in a statement. And Australia is only one of the stops on its journey. "Our partnership with Sonic Healthcare in Australia and the U.K. is one of our many efforts to make the most validated prenatal test available in Asia-Pacific, Europe and across the globe," Ariosa COO Dave Mullarkey said in a statement. Release

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