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More articles about Regulatory News & FDA Approvals

The company's +RNAinsight test, a combined DNA and RNA genetic test for hereditary cancer syndromes, was launched in October.

The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.

The Genetron Health S5 NGS system is based on the Thermo Fisher Scientific Ion GeneStudio S5 and will be accompanied by Genetron-developed assays.

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.

Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.

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 Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.

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.

The company said three clinical centers have validated the test in a prospective clinical trial involving more than 10,000 participants.

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 UK Competition and Markets Authority said blocking the deal could prevent a "substantial lessening of competition" in the NGS market.

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 test is the latest in a series of CE-IVD-marked assays the company has launched for use on Becton Dickinson's PCR-based BD Max platform.

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.

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The Economist reports that it is increasingly easier to analyze the metabolites people give off, potentially revealing personal information about them.

A controversial paper on the gender gap in science has been corrected, according to BuzzFeed News.

The Los Angeles Times reports that only a third of California students meet the state's new science standards.

In Science this week: evidence of interbreeding between the ancestors of West Africans and an unknown archaic human, and more.