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OncoMate is a fluorescent, multiplex PCR-based fragment sizing test that the company says can be performed using a portion of a single formalin-fixed, paraffin-embedded section. It targets five mononucleotide repeat markers, and results are available in about 10 hours.

FDA authorizes imported blue-top tubes

The FDA on July 22 issued an emergency use authorization to import and increase the supply of blue-top test tubes.

The EUA was issued to Becton, Dickinson, and Company for its BD Vacutainer Plus Citrate Plasma Tubes manufactured in the United Kingdom.

The CAP on June 15 issued recommendations (https://bit.ly/CAP_bluetop) to guide laboratories in reducing the clinical impact of the shortage of 3.2 percent sodium citrate blue-top tubes, which is expected to persist until the end of this year.

MET exon 14 skipping CDx approved

Foundation Medicine received FDA approval for FoundationOne Liquid CDx to be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping in metastatic non-small cell lung cancer for whom capmatinib may be appropriate.

Capmatinib (Tabrecta) is the first therapy the FDA approved for adult patients with metastatic NSCLC whose tumors have an alteration that leads to MET exon 14 skipping.