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MDx/CDx Focus: Quest Launches Lynch Syndrome Testing; CE-Mark for Biodesix Veristrat; and More


Quest Offering Lynch Syndrome Genetic Panel Testing in US

Quest Diagnostics has launched a new testing service for gauging patients' risk of Lynch Syndrome, or hereditary nonpolyposis colorectal cancer.

Lynch syndrome patients have inherited gene mutations that increase their risk of colorectal and other cancers. Quest is offering guidelines-based blood and tumor tissue testing services for newly diagnosed colorectal cancer patients or those with a family history of colorectal or Lynch syndrome related conditions. Through the testing service, available in all 50 states, patients and family members can also gain advice from genetic counselors.

Quest's Lynch syndrome test panel will evaluate MLH1, MSH2, MSH6, and PMS2 for inherited mutations associated with the disease. For some patients whose family history or tissue analysis suggests the involvement of certain genes, Quest will offer gene-specific testing. Healthcare providers can order various biopsy-tumor screening options for their patients with colorectal, endometrial, or other Lynch-associated cancers.

The company also offers options for colorectal cancer screening with the InSure FITTM fecal immunochemical test and ColoVantage, a blood plasma DNA test that helps doctors determine if patients have colorectal cancer based on the Septin9 marker. Quest also offers pharmacogenetic testing to gauge if colorectal cancer patients will respond to EGFR inhibiting treatments.

Before introducing its testing service of Lynch syndrome, Quest in October launched BRACAvantage, a test that gauges patients' hereditary risk for breast and ovarian cancer. Quest is advancing integrated diagnostic services that enable doctors to access guidelines-based testing technologies and advanced diagnostics and deliver personalized care.

Quest's Lynch syndrome test offerings come as the National Comprehensive Cancer Network has revised its guidelines to recommend that physicians should consider genetically testing those who have a 5 percent or greater risk of Lynch Syndrome on any mutation prediction model. Additionally, if no mutation is found with this initial testing, then doctors should test for mismatch repair genes MLH1, MSH2, MSH6, PMS2, and EPCAM.

With CE-Mark, Biodesix to Begin Marketing VeriStrat in EU

Biodesix has obtain a self-registration CE Mark for its VeriStrat specimen collection and shipping kit, which enables the company to offer testing to doctors in the European Union.

Biodesix is marketing the proteomic lung cancer test as a tool that doctors can use to determine the best treatment – Tarceva (erlotinib) or chemotherapy -- for second-line, non-operable, advanced non-small cell lung cancer patients. The test is meant to help guide treatment decisions for patients who don't harbor EGFR mutations or whose EGFR mutation status is unknown.

In the nearly 300-patient Phase III, prospective trial, called PROSE, patients classified by Biodesix's test as Veristrat "poor" had a significantly poorer response to Tarceva than chemotherapy. While Veristrat "good" patients responded equally well to chemo or Tarceva.

Arno Signs Exclusive License for Gene Expression Signature with U of M

Arno Therapeutics has signed an exclusive license agreement with the University of Minnesota that gives it access to technology "related to a gene expression signature derived from archived breast cancer tissue samples."

According to the company, this method can help Arno assess progesterone-stimulated pathway activation and identify best responders to its lead investigational agent onapristone. The terms of the deal with the University of Minnesota allows Arno to advance the PR gene signature as a predictive companion diagnostic for anti-progestins, such as onapristone, and to use the test in clinical trials of the drug.

Arno recently announced that it has enrolled the first patient in a Phase I dose escalation study investigating onapristone in post-menopausal women with progesterone receptor-positive breast, endometrial, and other solid tumors.