The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.
Agena has an ongoing partnership with Guangzhou-based DaRui to develop MassArray-based diagnostics for cancer and inherited diseases for the Chinese market.
The a single-tube, multiplex real-time PCR-based MeltPro High Risk HPV test identifies 14 high-risk genotypes of human papillomavirus and was previously CE marked.
With CE-IVD marking, the melt curve analysis-based screening assay is available for sale in the EU and other areas that recognize the designation.
The firm said that the assay uses vaginal or rectal swabs to identify Group B Streptococcus DNA in about an hour. It has filed for 510(k) clearance with the US FDA.
The test is designed to detect the presence or absence of the Zika virus in serum or plasma collected alongside urine from patients with suspected infection.
The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
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 PCR assay is intended to help detect TB-causing bacteria and determine if it harbors mutations associated with isoniazid and rifampicin resistance.
The agency issued draft guidance on minimal residual disease as a biomarker and finalized another guidance on developing drugs with pan-cancer indications.
The companion diagnostic for Pfizer's Xalkori identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids.
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 kit is designed to quantify HIV-1 RNA in blood samples and runs on Bioneer's PCR-based ExiStation automated molecular diagnostics system.
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 firm's molecular assay directly detects varicella-zoster virus DNA from a patient's cerebrospinal fluid and provides results in about one hour.
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.
Noridian GBA has issued the LCD for use of the Decipher Prostate Biopsy genomic classifier in patients with very low and low-risk prostate cancer.
Senator Lamar Alexander (R-Tenn.), who chairs the Senate health committee, will be retiring at the end of his term, Stat News reports.
UCSF researchers find that having two X chromosomes may contribute to women's longer lifespans, according to Discover's D-brief blog.
The Wall Street Journal reports on the US Centers for Disease Control and Prevention's use of genetic approaches to study foodborne illnesses.
In PNAS this week: immune cell profiling of wild baboons by social status, metabolomics profiling of esophageal tumors, and more.