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The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
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.
The cancer test developer will use the funding to commercialize its enrichment-based NGS panels. An IVD test also got CE marked.
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 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.
New analyses indicate female researchers are publishing less during the coronavirus pandemic than male researchers, according to Nature News.
A study suggests people with the ApoE e4 genotype may be more likely to have severe COVID-19 than those with other genotypes, the Guardian says.
Direct-to-consumer genetic testing companies are searching for a genetic reason for why some people, but not others, become gravely ill with COVID-19, the Detroit Free Press reports.
In PNAS this week: forward genetics-base analysis of retinal development, interactions of T cell receptors with neoantigens in colorectal cancer, and more.