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regulatory approval

The company said it expects to ship nearly 30 million of its SARS-CoV-2 serology tests in May globally and will have capacity for 60 million tests in June.

The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.

The system is approved for use with the Procleix Ultrio Elite Assay, the Procleix WNV Assay, Procleix Zika Virus Assay, and the Procelix Babesia Assay.

The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.

The company's PD-L1 IHC 22C3 pharmDx identifies patients with non-small cell lung cancer who qualify for first-line monotherapy with pembrolizumab.

The test, which is used to screen for cervical cancer, was previously approved by the agency for use with the Cobas 4800 system.

The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.

The tests, from Tennessee's Integrity Labs and Florida's Baptist Hospital Miami, bring the total number of authorized laboratory-developed assays to 12.

The NeuMoDx SARS-CoV-2 Test Strip can run on the firm's fully-automated mid- or high-throughput instruments.

Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.

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