regulatory approval

The Fusion module is an in-lab upgrade to Hologic's Panther instrument, which enables labs to extend the testing capabilities of their existing Panther. 

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.

The firm's LeukoStrat CDx FLT3 Mutation Assay detects internal tandem duplications and tyrosine kinase domain mutations in patients with acute myeloid leukemia.

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.

With the accreditation, the La Jolla, California-based molecular dermatology firm can provide its services in all 50 states and the District of Columbia.

Designed to run on the company's Sentosa real-time PCR system, the test has been approved for identifying and differentiating Zika in patients.  

The PCR-based cartridge is designed to detect 21 pneumonia pathogens and 19 genetic markers of antibiotic resistance, and runs on the company's Unyvero system.

A new report from the Personalized Medicine Coalition highlights new personalized medicines approvals by the US Food and Drug Administration.

The real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples.

The genetic testing firm can now offer its Prelude noninvasive prenatal test to residents in New York State.

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Sometimes genetic tests give inconclusive results and provide little reassurance to patients, the Associated Press reports.

Vox wonders whether gene-editing crops will be viewed similarly as genetically modified organisms of if people will give them a try.

In Science this week: research regulation and reporting requirement reform, and more.

With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.