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MolecularMD Licenses LKB1 Marker for Lung Cancer Assay Development

NEW YORK (GenomeWeb News) – MolecularMD today said it has licensed a genetic marker for the development of diagnostic assays for non-small cell lung cancer.

The Portland, Ore.-based company has licensed the rights to commercialize the intellectual property around the biomarker LKB1 for diagnostic, prognostic, and predictive use, it said. The patent rights for LKB1 are jointly owned by the Dana-Farber Cancer Institute; the Massachusetts General Hospital; the University of North Carolina, Chapel Hill; and the University of Texas Southwestern Medical Center.

MolecularMD said it is developing both immunohistochemistry- and next-generation sequencing-based assays for the determination of LKB1 status.

LKB1 is a tumor suppressor that encodes "a serine/threonine kinase that negatively regulates the mTOR signaling pathway," MolecularMD said. The gene is mutated in 20 percent to 30 percent of NSCLC cases, and the loss of LKB1 protein is predictive of a cancer's aggressiveness, "especially in the context of KRAS mutation," according to the firm. As a result, LKB1 "is likely to be an important biomarker" that can be used to predict how a patient may respond to targeted agents and chemotherapy, the company added.

In addition to assay development, MolecularMD will support commercialization of the LKB1 technology by sublicensing it to clinical reference laboratories and diagnostic assay developers and manufacturers, it said.

Financial and other terms of the deal were not disclosed.

"Tumor suppressors play a critical role in determining responsiveness to therapies targeting oncogenes," Sabita Sankar, MolecularMD's scientific affairs liaison, said in a statement. "MolecularMD's offering of both LKB1 IHC and NGS assays will provide critical additional information to predict responsiveness to both targeted agents and chemotherapy especially in the context of MEK inhibitors in KRAS mutant lung adenocarcinoma."

MolecularMD develops specialty molecular diagnostics for the monitoring and management of cancer patients being treated with molecularly-targeted cancer therapies. In December it partnered with Roche's Ventana Medical Systems for research into PTEN detection and expression.

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