The designation will help the company accelerate the process of bringing the opioid addiction risk test through regulatory review and clearance.
Makers of genetic health risk tests will only need one FDA review before commercializing tests, with some exceptions.
The test is Micronics’ first to receive FDA clearance, and the company is pursuing CE marking for it and the PanNAT system.
The China FDA has approved Vela's cell-free DNA extraction kit, which can be coupled with RT-PCR or NGS workflows for further analysis.
Consent — and the right to withdraw it — underlies the EU's newly effective General Data Protection Regulation for researchers in Europe and beyond.
BioGx now offers 11 CE-marked infectious disease tests that run on Becton Dickinson's BD Max platform.
IncellDx HPV OncoTect 3Dx system combines the quantification of oncogene mRNA overexpression, proliferation, and aneuploidy in one high-throughput assay, according to the firm.
The kit, designed to rapidly detect 16 beta-lactam and carbapenem-resistant pathogen targets, was CE marked last month.
The claim, enabling streamlined screening of pooled samples, follows updated industry recommendations for Zika virus screening in the US blood supply.
The agency asked Reps. Bucshon and DeGette to consider the precertification program idea as they work on refining the draft of the Diagnostic Accuracy and Innovation Act.
The company submitted the platform and gastrointestinal panel to the US Food and Drug Administration for clearance earlier this year.
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
The test cartridge runs on the company's Unyvero platform and covers 103 diagnostic targets for various pathogens and markers of antibiotic resistance.
The firm said that its Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections on its 6800 and 8800 systems.
The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.
The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.
The firm also received approval from the Singapore Health Sciences Authority to market the Unyvero blood culture cartridges.
The test is approved as a companion diagnostic that can determine which advanced breast cancer patients have BRCA1/2 genetic mutations and will likely respond to Lynparza.
The firm has launched a multiplex real-time PCR assay that detects HPV 16, HPV 18, and a pool of 12 other high-risk HPV subtypes.
The approvals allow the company to offer its PCR-based expression profile cancer risk tests in the state.
The New York Times and ProPublica look into the close relationship between a startup and Memorial Sloan Kettering Cancer Center.
Yahoo News reports millions of dollars are being transferred from NIH, CDC, and other programs to pay for the housing of detained undocumented immigrant children.
In Science this week: in vitro generation of human reproductive cells, and more.
Researchers gave a handful of octopuses MDMA to find that they too act more social on the drug, Gizmodo reports.