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Author Archives: Kristen

Therascreen EGFR RGQ PCR kit approved as CDx

Oct. 1, 2018—Qiagen announced that the FDA has approved a PMA supplement expanding the labeling claim of the Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or an exon 21 L858R mutation.

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Roche announces availability of FoundationOne Liquid

Sept. 27, 2018—Roche announced that its FoundationOne Liquid, a blood-based genomic profiling test, is available worldwide. FoundationOne Liquid can identify circulating tumor DNA in the blood of people with cancer and can identify 70 of the most commonly mutated genes in solid tumors, including microsatellite instability.

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Beckman releases new version of middleware

Sept. 12, 2018–Beckman Coulter launched version 1.10 of its Remisol Advance middleware system for mid- to high-volume laboratories. Enhancements include a centralized dashboard that combines sample status information (pending, stat, validated, and processed), turnaround time data, and quality control alerts in an intuitive format. “By providing a snapshot display of important analytics in a single location, we are enabling technologists ...

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Fingerstick Sofia 2 Lyme FIA gets FDA clearance, CLIA waiver

Sept. 6, 2018—Quidel has received 510(k) clearance and Clinical Laboratory Improvement Amendments waiver from the FDA to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from fingerstick whole blood specimens from patients suspected of B. burgdorferi infection. The test is ...

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Study: SelectMDx cost-effective in four European countries

Aug. 30, 2018—MDxHealth announced that a study validating the cost-effectiveness of SelectMDx for Prostate Cancer has been published in Prostate Cancer and Prostatic Diseases (Govers TM, et al. Epub ahead of print Aug. 20, 2018. doi:10.1038/s41391-018-0076-3). The study evaluates the potential cost-effectiveness of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in a ...

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