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regulatory approval

The assay is designed to detect ribosomal RNA from four clinically relevant Babesia species and runs on the company's Procleix Panther system.

The test uses multiplex PCR fragment analysis with Promega-designed five-mononucleotide repeat markers to detect the MSI-high phenotype within tumor tissues.

Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.

The tests are designed to detect genetic variations including SNPs, insertion-deletions, copy number variations, and variations in segmental duplications.

Foundation Medicine's assay detects genomic alterations in 324 cancer genes and serves as a companion diagnostic for patients with certain types of tumors.

The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.

The firm’s test for detecting flu and differentiating between subtypes A and B is being launched in Europe, Asia, and South America.

The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.

The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.

With the approval, MDxHealth can now offer its liquid biopsy molecular diagnostic assay in all 50 US states.

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The US Department of Justice has proposed a rule change to enable DNA to be collected from migrants, the Associated Press reports.

Bernard Fisher, a surgeon who changed how breast cancer is treated, has died at 101, the New York Times reports.

Washington Post columnist writes that she is skeptical about DNA-based diets.

In PNAS this week: recurrent inactivation of DEPDC5 in gastrointestinal stromal tumors, taxonomic reliability of GenBank sequences, and more.