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Biodesix Receives CE Mark for VeriStrat Specimen Collection and Shipping Kit

Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, recently announced that it has obtained the CE Mark for its VeriStrat® specimen collection and shipping kit, clearing the company to make VeriStrat results available to physicians in the European Union and other countries recognizing the CE Mark. VeriStrat is a non-invasive, blood-based protein diagnostic that predicts differential treatment outcomes between two types of therapies for second-line treatment of non-operable, advanced non-small cell lung cancer (NSCLC): chemotherapy or the targeted drug erlotinib (Tarceva®). Physicians use VeriStrat results, in combination with other clinicopathological factors, to guide therapy decisions for non-small cell lung cancer patients.

MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy

MolecularMD Corp. recently announced that it has entered into a license agreement granting the company exclusive patent rights to cancer diagnosis technology. Specifically, MolecularMD has obtained rights to commercialize patent-pending intellectual property pertaining to DDR2 mutations for diagnostic, prognostic and predictive uses for humans in the area of lung cancer. Such patent rights are jointly-owned by The Broad Institute and Dana-Farber Cancer Institute. The inventors named on the patent are Drs. Matthew Meyerson, Peter Hammerman, and Alexis Ramos.

About DDR2 Mutations in Lung Cancer

Research into understanding the genetic basis of cancer has led to identification of novel biomarkers that have been successfully exploited with targeted therapies. In non-small cell lung cancer (NSCLC), several such targets have been discovered for adenocarcinoma including EGFR, ALK, and MET. Unfortunately, these therapeutic targets are not relevant for squamous cell carcinoma (SCC), which is the second most frequent histological subtype in NSCLC. Recent discoveries identified mutations in the discoidin domain receptor 2 (DDR2) of SCC patient tumors that are oncogenic and also responsive to existing drugs targeting kinase inhibition. DDR2 is a membrane receptor tyrosine kinase involved in cell adhesion, proliferation and migration. In xenograft models, DDR2-mutant tumors regressed under treatment with the tyrosine kinase inhibitor, dasatinib. Remarkably, an SCC patient with no detectable EGFR mutation had a long-term response to the combination of erlotinib plus dasatinib. This patient was found to harbor a DDR2 mutation further suggesting that DDR2 mutations may be clinically relevant. Given the availability of a variety of therapies targeting tyrosine kinases, these findings provide a rationale for designing clinical trials for patients with SCC using existing FDA-approved drugs such as dasatinib, imatinib, nilotinib and ponatinib as well as novel, selective tyrosine kinase inhibitors for DDR2.

MolecularMD is developing DDR2 diagnostic assays, including next-generation sequencing tests, for clinical trials exploring efficacy of targeted therapies and DDR2 clinical utility. MolecularMD provides comprehensive clinical trial support through its CLIA-certified and CAP-accredited Clinical Reference Laboratory. In addition, MolecularMD provides IVD development and manufacturing capability to support companion diagnostic device commercialization. MolecularMD will also support commercialization of DDR2 technology through sublicensing to clinical reference laboratories and diagnostic assay developers and manufacturers.

According to Dr. Greg Cox, MolecularMD’s Director of Licensing, “DDR2 is potentially the first actionable biomarker available for SCC patients, whose treatment options are currently limited to chemotherapy. It’s exciting that these patients may benefit from existing FDA-approved targeted therapies, and we are eager to support clinical trials examining these novel treatment possibilities and enable widespread access to DDR2 diagnostics.”

Biodesix Secures Medicare Coverage for VeriStrat Test

Biodesix, Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, recently announced that Novitas Solutions, the Medicare Administrative Contractor for the region that includes Colorado, has established coverage for the company’s VeriStrat test. VeriStrat, a clinically validated blood-based protein test, helps physicians guide second-line therapy for patients with advanced non-small cell lung cancer (NSCLC). The coverage decision means that more than 49 million eligible Medicare enrollees in the U.S. will now be able to benefit from VeriStrat being a covered diagnostic test, according to specific lung cancer indications outlined by Novitas.

Lung cancer is the most common cancer worldwide, and is the leading cancer killer in both men and women in the United States. The five-year survival rate for lung cancer is roughly 15 percent, illustrating the need for predictive biomarker tests that can identify which therapies are most appropriate for individual patients. VeriStrat fills that role; the test was recently evaluated in a phase III clinical trial, with data presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting. Results confirmed that VeriStrat is predictive of differential treatment outcomes for the two types of therapies used in second-line treatment of advanced NSCLC: chemotherapy or the targeted drug erlotinib (Tarceva®).

Erlotinib, an EGFR inhibitor, is the drug most commonly used in patients who harbor an EGFR mutation. However, only a small percentage of patients have this mutation. The VeriStrat test helps oncologists guide treatment decisions between erlotinib and single agent chemotherapy in advanced lung cancer patients who do not harbor an EGFR mutation or whose mutation status cannot be obtained. VeriStrat requires only a simple blood draw and test results are returned in less than 72 hours, allowing physicians to make quick treatment decisions.

“Medicare’s decision to offer VeriStrat as a covered benefit will allow those patients enrolled in Medicare to benefit from better-informed, personalized decision-making when it comes to the treatment of their disease,” said David Brunel, Chief Executive Officer of Biodesix. “This is a major milestone for both Biodesix and for patients with lung cancer. Using the information from VeriStrat test results, physicians can improve patient outcomes by identifying the best course of treatment.”

Medicare’s positive coverage decision for VeriStrat, published in Novitas’ “Biomarkers for Oncology” Local Coverage Decision (LCD), describes multiple predictive and prognostic biomarkers in multiple tumor types. VeriStrat is included in the non-small cell lung cancer (NSCLC) section.

FDA Accepts Supplemental New Drug Application for Tarceva (Erlotinib) Tablets for Genetically Distinct Form of Advanced Lung Cancer

Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations. The application has been granted Priority Review status, and an FDA decision is expected in the second quarter of 2013. A pre-market approval (PMA)
application for a companion diagnostic, the cobas® EGFR Mutation Test developed by Roche Molecular Diagnostics, has also been submitted to the FDA.

Cancer Biomarker Study Data Presented at the 2011 AACR Meeting

A roundup of five research studies on cancer biomarkers that were presented earlier this week at the American Association for Cancer Research (AACR) 102nd Annual Meeting in Orlando, Florida.