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Therascreen EGFR RGQ PCR kit approved as companion diagnostic for Vizimpro

October 2018—The FDA has approved a PMA supplement expanding the labeling claim of the Qiagen Therascreen EGFR RGQ PCR kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib). Vizimpro is for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or an exon 21 L858R mutation.

The Therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also Gilotrif (afatinib) from Boehringer Ingelheim and Iressa (gefitinib) from AstraZeneca. It is registered in more than 40 countries. This was a project governed under an agreement between Qiagen and Pfizer.

Roche announces liquid biopsy ctDNA test

Roche announced on Sept. 24 the worldwide availability of Foun­da­tion­One Liquid, a liquid biopsy test. FoundationOne Liquid can identify circulating tumor DNA and 70 of the most commonly mutated genes in solid tumors, Roche said, including microsatellite instability.

FoundationOne Liquid complements the tissue-based test FoundationOne CDx.

Philips introduces computational pathology software for tumor detection

Royal Philips announced in September the latest release of TissueMark, which the company says now supports region of interest detection for the majority of molecular testing and helps research labs improve the accuracy of tumor estimation.

The new version, showcased Sept. 8–12 at the 30th European Congress of Pathology 2018, uses deep learning artificial intelligence to aid in prostate and ovarian tumor tissue identification.

Innovative computational solutions can help pathologists improve efficiency in the research setting, Philips says, which will ultimately help support precision medicine and enhance the speed and accuracy of diagnosis.

In addition to providing tumor sufficiency guidance for lung histology, lung cytology, and colon and breast tissue samples in 60 seconds, the updated TissueMark software now provides this guidance to whole slide images of adenocarcinoma prostate tissue and high-grade serous carcinoma ovarian tissue.

FDA clearance, CLIA waiver for POC Sofia 2 Lyme FIA

Quidel received 510(k) clearance and CLIA waiver from the FDA to market its Sofia 2 Lyme fluorescent immunoassay. The assay is 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.