The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.
The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
The fully automated system has 12 independent thermal cyclers and runs the firm's diagnostic kits, but it can also operate as an open instrument.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The agency issued draft guidance on minimal residual disease as a biomarker and finalized another guidance on developing drugs with pan-cancer indications.
The ID Core XT is the second molecular assay approved by the FDA for use in transfusion medicine and the first to report genotypes as final results.
The firm has completed submissions for all three of its ePlex panels for diagnosis and management of bloodstream infections that can lead to sepsis.
The BioCode GPP tests for 17 of the most common bacteria, viruses, and parasites that cause infectious diarrhea, and runs on the BioCode MDx-3000 system.
In granting de novo premarket authorization to ClonoSeq, the agency established its regulatory expectations for similar tests.
The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.
At a meeting this week, researchers and others discussed the regulatory oversight needed for germline genome editing.
The US Food and Drug Administration has asked questions about Myriad Genetics' GeneSight test, according to Bloomberg.
Researchers report that neutrophil extracellular traps appear to binds gallstones together, according to New Scientist.
In Science this week: approach to infer genotype-by-environment interaction from genetic variants associated with phenotypic variability, and more.