The company also said that it expects a clearance decision from US regulators in the near term on a lower respiratory tract infection test that runs on its Unyvero system.
The company's antibiotic-induced hearing loss test will be used to screen babies for a genetic mutation that can cause deafness when given certain antibiotics.
The T2Resistance Panel, which runs on the T2Dx instrument, detects 13 genes conferring antimicrobial resistance directly from whole blood in three to five hours.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
The assay, which received premarket approval last year, detects 14 high-risk HPV types and individually identifies and reports HPV genotypes 16, 18, and 45.
The tubes and collection kits meet the requirements of the European In-Vitro Diagnostic Devices Directive, and the company can now commercialize the devices throughout Europe.
Due out in December, the Magnis automated library prep instrument is meant to be an affordable and easy way for researchers to use Agilent's SureSelect kits.
For heavily pretreated ovarian cancer patients, doctors will now have to weigh their HRD status in the context of an increasingly complex backdrop of biomarker information.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The Economist reports that it is increasingly easier to analyze the metabolites people give off, potentially revealing personal information about them.
