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regulatory approval

The company said that by the end of June it would have made available more than 500,000 kits, which allow individuals to self-collect nasal samples at home.

The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.

The IgG antibody test runs on the Architect i1000SR and i2000SR instruments and will expand to the company's Alinity i system.

The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.

Clinicians will be able to use the assay to help identify patients with metastatic NSCLC for treatment with nivolumab and ipilimumab. 

The cancer test developer will use the funding to commercialize its enrichment-based NGS panels. An IVD test also got CE marked.

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.

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