• AdvanDx (Woburn, Massachusetts) reported FDA clearance for EK/P. aeruginosa PNA FISH to identify Escherichia coli and/or K. pneumoniae as well as Pseudomonas aeruginosa directly from positive blood cultures. The company says that EK/P. aeruginosa PNA FISH is the first-ever test capable of identifying E. coli and/or K. pneumoniae and P. aeruginosa directly from positive blood cultures and that the PNA FISH tests now provide rapid, therapy-guiding results for 95-99% of patients with bloodstream infections and positive blood cultures. PNA FISH is a sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don't require the extensive sample preparation necessary for other nucleic acid technologies.

• Biodesix (Broomfield, Colorado) reported U.S. commercial availability of VeriStrat, a blood-based, proteomic test for patients with advanced stage non-small cell lung cancer (NSCLC). VeriStrat identifies patients who are likely to have good or poor outcomes following treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), such as erlotinib. VeriStrat, in addition to other clinical factors, provides information to help oncologists make more informed decisions regarding treatment selection. VeriStrat uses mass spectrometry paired with Biodesix' algorithms to determine a patient's VeriStrat classification: VeriStrat Good or VeriStrat Poor. VeriStrat is a pretreatment serum, proteomic test for patients with advanced NSCLC. The test identifies patients who are likely to have good or poor outcomes after treatment with EGFR-TKIs. Samples are processed in Biodesix' CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment.

• Clarient (Aliso Viejo, California) has introduced a new breast cancer test that helps physicians identify the probability of a patient's cancer recurring and assess the need for chemotherapy. The new prognostic test, Insight Dx Breast Cancer Profile, has been clinically validated for women with early-stage, hormone-receptor-positive breast cancer. The Insight Dx Breast Cancer Profile combines three traditional pathology staging risk factors with seven key molecular markers. Staging factors are tumor size, tumor grade, and lymph node status. Molecular markers include ER, PR, HER2, EGFR, BCL2, p53, and MYC.