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FDA clearance

At the WIN Symposium, a Merck executive detailed how data from a basket study led to the first pan-cancer, biomarker-informed cancer drug. 

The kit was previously approved by FDA for use on Qiagen's Rotor-Gene Q real-time PCR platform, which is one component of the automated QiaSymphony platform.

The FDA approved the real-time PCR-based test for use on the Cobas 6800 and 8800 systems to assess the response of transplant patients to treatments. 

The GenePOC GBS LB assay uses real-time PCR technology to detect GBS colonization from lim broth samples with sensitivity of 95.9 percent and specificity of 95.5 percent. 

The real-time PCR, sample-to-answer assay provides surveillance of whooping cough, a contagious respiratory disease, in clinically symptomatic patients.

The Ventana PD-L1 assay was approved as a complementary diagnostic for bladder cancer patients being considered for treatment with the immunotherapy Imfinzi. 

The test runs on Qiagen's Rotor-Gene Q MDx system and is designed to qualitatively detect the JAK2 V617F/G1849T allele in genomic DNA from whole blood.

The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument. 

To develop the test, the firm said it used a library of MRSA strains collected around the world, and included components that reduce false positive results.

The firm said that molecular product sales were up 103 percent, driven by the launch of the Solana Group A Strep assay earlier this year.

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The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.

Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.

Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.

In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.