regulatory approval

The firm said that with the approval, the firm's liquid biopsy-based ExoDx Prostate IntelliScore (EPI) test is now available in every state.

The Columbia Solid Tumor Panel, a custom NGS panel from Pillar Biosciences, will be used at CUMC's Laboratory of Personalized Genomic Medicine.

The company will now be able to market the test, which algorithmically weighs molecular markers and clinical information, in all 50 US states.

With the approval of its ThyraMIR diagnostic assay, the firm said that physicians will have access to its thyroid product suite across several specimen types.

Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.

Based on PCR technology acquired from Hain Diagnostics, the test and platform enable rapid detection of TB, as well as assessment of antibiotic resistance.

The PhosphorusOne test uses next-generation sequencing to analyze 375 genes covering 170 inherited conditions and 175 different drug reactions.

The kit is approved for the qualitative detection of BRCA1 and BRCA2 mutations in patients with different cancer types including breast cancer.

The test is for monitoring treatment response in chronic myeloid leukemia and uses a new Droplet Digital PCR instrument.

The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.