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It is the first time that the agency has authorized for marketing a next-generation sequencing test for HIV-1 resistance, the FDA noted.
The company said three clinical centers have validated the test in a prospective clinical trial involving more than 10,000 participants.
The program will likely only generate sequencing data, not genotyping array data, for returning health-related results to reduce the complexity associated with two platforms.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
The nonpartisan federal agency's report suggests ways for Congress, the FDA, FTC, and CMS to expand oversight of the genetic testing market.
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.
Temple City, California-based Fulgent offers genetic tests for a range of diseases and disorders, as well as custom panels and sequencing services.
The regulatory approval means that the assay for minimal residual disease is available to monitor B cell blood cancers in patients in all 50 states.
Nature News reports that recent proposed changes to the US National Science Foundation have raised concerns about a shift away from the agency's focus on basic research.
Noel Rose, the "father of autoimmunity," has died at 92, the Washington Post reports.
According to CNN, Legionella was discovered in buildings leased by the Centers for Disease Control and Prevention as they reopened following coronavirus pandemic-related closures.
In PLOS this week: genetic analysis of malaria parasite populations in Southeast Asia, genomic surveillance of yellow fever virus in São Paulo, and more.