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FDA clears 2 of 3 ePlex blood culture ID panels

January 2019—GenMark Diagnostics announced in December that it received FDA market clearance for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) and Fungal Pathogen (BCID-FP) panels.

GenMark’s third panel, ePlex Blood Culture Identification Gram-Negative (BCID-GN), was submitted to the FDA in September 2018 and is still under review.

The fungal pathogens panel has broad coverage and includes many resistant and emerging strains, among them Candida auris, GenMark said in its statement.

The company says that by coupling BCID panels with the ePlex Templated Comments software module, hospitals can enable immediate intervention linked to a diagnostic result and improve the effectiveness of antimicrobial stewardship initiatives.

12 assays for Atellica Solution

Siemens Healthineers achieved 12 pre-market approvals from the FDA for its Atellica Solution infectious disease and oncology testing menu.

The infectious disease tests approved last year for the Atellica Solution are for HIV (HIV Ag/Ab Combo and HIV 1/O/2 Enhanced) and hepatitis B and C (Anti-HBs 2, HBsAg II, HBsII Confirmatory, HBc IgM, HBc Total, HBeAg, and HCV). Also approved last year: PSA, cPSA, and AFP assays.

“These 12 PMA assays, combined with recently released high-sensitivity troponin I and procalcitonin assays, provide a comprehensive menu on the Atellica Solution,” Deepak Nath, PhD, president, laboratory diagnostics, Siemens Healthineers, said in a statement.

Qiagen to develop companion Dx for PIK3CA-mutated advanced breast cancer

Qiagen reported that it has a clinical development program underway with Novartis to bring to market a molecular test to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women living with PIK3CA-mutated hormone-receptor–positive/HER2-negative advanced or metastatic breast cancer.

The Novartis drug candidate is in late-stage development.

Qiagen says its companion diagnostic for PIK3CA mutations will provide a Sample to Insight workflow, from DNA extraction to detection of the clinically relevant mutations and final reporting. The test will be clinically validated for analysis of FFPE tissue and liquid biopsy samples using plasma. It will run on the Rotor-Gene Q MDx cycler.

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