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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.”

Atherotech Diagnostics Lab Expands Heart Disease Atherotech Diagnostics Lab Expands Heart Disease Risk Assessment with AspirinWorks® Test

Atherotech Diagnostics Lab, a leading clinical reference laboratory specializing in cardiometabolic testing and disease management solutions, recently launched the AspirinWorks® Test to complement its menu of cardiovascular disease risk assessment tests.

More than 1 million Americans experience new or recurrent heart attacks each year. These at-risk individuals are candidates for aspirin therapy and should be tested for the presence or absence of the therapy’s effect. The AspirinWorks Test is used to determine levels of 11‑Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids a physician in the determination of aspirin effect.

“The AspirinWorks Test maximizes the value of our VAP Lipid Panel and accompanying line of cardiometabolic disease diagnostics and management tests,” Atherotech CEO Michael Mullen said. “This offering is strategically aligned with our company’s mission to proactively manage risk and guide therapy to help improve patient outcomes.”

Aspirin therapy works on blood platelets to decrease levels of thromboxane A2 (TxA2), a powerful stimulator of platelet aggregation. Lower thromboxane levels and decreased platelet aggregation means less chance of developing a blood clot, and therefore, less chance of a heart attack or stroke. However, studies have shown that for several reasons, up to 25 percent of individuals do not get the expected beneficial effect of aspirin.

The AspirinWorks Test identifies those individuals who have elevated thromboxane levels despite taking a daily aspirin dose.

“The added information from the AspirinWorks Test will help provide a more accurate and complete evaluation of a patient’s cardiovascular health,” Atherotech Chief Medical Officer Michael Cobble, M.D., said. “Assessment of the chemical marker for platelet aggregation facilitates a strategic, scientifically validated approach to maximizing the value of aspirin therapy and minimizing the risk of heart attack and stroke.”

The AspirinWorks Test has been clinically validated through extensive research and numerous well-designed and well-powered clinical trials. The AspirinWorks Test is FDA cleared and used to test and guide treatment for hundreds of thousands of patients each year worldwide.

Atherotech provides a full complement of more than 60 routine and specialty diagnostic tests, including its patented VAP® Lipid Panel to help physicians establish the most effective course of treatment from a single source.

Source: Atherotech Diagnostics

Veridex and LabCorp Agreement Brings CellSearch CTC Test to China

Veridex, LLC recently announced an agreement with LabCorp Clinical Trials that makes the CELLSEARCH® circulating tumor cell (CTC) test available for researchers conducting clinical trials in China. This marks the first clinical reference laboratory in China that offers CTC testing and comes on the heels of China’s State Food & Drug Administration approval of CELLSEARCH® as an in vitro diagnostic to manage patients with metastatic breast cancer.

BG Medicine, Inc. Announces Availability of Galectin-3 Testing Through Cleveland HeartLab, Inc.

BG Medicine, Inc., a company focused on the development and commercialization of novel, biomarker-based diagnostics, announced today that Cleveland HeartLab, Inc. is now offering BGM Galectin-3 testing services.

CompanDX, Clinical Reference Laboratory (CRL) Collaborate On Gene Signature and Companion Diagnostic Development

CompanDX Ltd. bioinformatics partner for the life sciences industry and Clinical Reference Laboratory, Inc. (CRL), provider of laboratory testing services in molecular diagnostics and clinical trials, announced recently that they are entering into a multi-year agreement to collaborate in the development and support of biomarker panels and companion diagnostic development for pharmaceutical, biotech and academic clients worldwide. Under the terms of the agreement, CompanDX will continue its trailblazing bioinformatics work on its “Distiller” platform, which includes the development of the first “Time to Event” breast cancer signature supported by CRL’s CLIA-certified laboratory services.