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 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.
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 Washington Post reports that a US Senate committee voted this week to approve the nomination of Stephen Hahn to lead the Food and Drug Administration.
In Nature this week: resources for single-cell analysis, little overlap in the microRNAs used by Salmonella and Shigella to infect host cells, and more.