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.
At the ACLA conference this week, FDA Commissioner Gottlieb outlined his vision for the agency in the realm of LDTs.
FDA's blessing for 23andMe's test that gauges select BRCA1/2 variants has the cancer community worried about whether consumers will understand its limitations.
The company can now offer to Florida residents the blood-based colorectal cancer monitoring test Colvera.
23andMe's genetic health report is for three BRCA1 and BRCA2 mutations most commonly found in people of Ashkenazi Jewish descent.
The Artus T. vaginalis QS-RGQ kit is designed for the qualitative detection of Trichomonas vaginalis DNA purified from clinician-collected patient samples.
The Blood Profiling Atlas in Cancer Consortium released its first public data last month, revealing some of its work with the US Food and Drug Administration.
With the accreditation, the La Jolla, California-based molecular dermatology firm can provide its services in all 50 states and the District of Columbia.
The PAXgene Blood ccfDNA tube enables clinical laboratories to stabilize samples when they cannot be processed on the day they were collected.
New Medicare rates established under PAMA will cause labs to scale back services, and in some cases shut down, the motion states.
The test reduces hands-on time by enabling labs to simultaneously assess Factor II and Factor V gene mutations from a single patient sample, Roche said.
The test runs on the BD Viper LT system and detects 14 high-risk types of human papilloma virus.
The company has also developed two liquid biopsy cancer test, Liquid GPS Core for DNA and Liquid GPS Expression for RNA.
The Sentosa SA201 HSV-1/2 PCR test detects herpes virus DNA from oral or anal skin lesions in symptomatic patients.
The molecular test can provide results in 30 minutes from nasal swabs on a palm-sized instrument.
Lawmakers have asked four direct-to-consumer genetic testing companies to explain their privacy policies and security measures, according to Stat News.
The Trump Administration has proposed a plan to reorganize the federal government, the Washington Post reports.
In Science this week: genetic overlap among many psychiatric disorders, and more.
The Economist writes that an increasing number of scientific journals don't do peer review.