MolecularMD Corp. Offers Testing Services for Determining LKB1 Mutation and Expression Status

PORTLAND, OR--(Marketwired - Apr 9, 2013) - MolecularMD Corp. announced today that it has developed and clinically validated assays for determining LKB1 mutation and expression status in patient tumor samples. LKB1 is a tumor suppressor gene and loss of LKB1 protein has been reported in several tumors and is associated with greater resistance to targeted therapies. Molecular testing for LKB1 is offered by MolecularMD's CLIA-certified and CAP-accredited clinical reference laboratory.

Immunohistochemistry (IHC) and Next Generation Sequencing (NGS) tests were validated on a set of 34 tumor samples including lung, endometrium, skin, pancreas, colon and breast. The IHC assay was developed on an automated Ventana™ Benchmark XT platform and the NGS assay was developed on Life Technologies Ion Torrent PGM™ platform. Combining IHC and NGS provides complementary information about the LKB1 gene status. The LKB1 targeted sequencing panel covering 9 exons provides a robust and accurate test to identify all clinically relevant mutations with frequencies as low as ~5%. The PGM™ platform's low 20ng DNA input requirement is particularly well suited for rare amounts of tissue samples.

The results from this work will be presented at the AACR Annual Meeting 2013, April 6-10 in Washington, DC. The presentation will occur on April 9^th, Poster #3509 titled "Complementary Analysis of LKB1/STK11 Mutation and Protein Expression Status using Next-Generation Sequencing, Sanger Sequencing and Immunohistochemistry."

About LKB1 in Lung Cancer
Research conducted by Dr. Kwok-Kin Wong at Dana-Farber Cancer Institute has shown that the gene named LKB1 (liver kinase B1) (also known as STK11) is frequently inactivated through deletions or point mutations in a wide variety of human cancers. In fact, LKB1 is mutated in 20-30% of non-small cell lung cancers and ranks as the 3^rd most frequently mutated gene in lung adenocarcinoma after the p53 tumor suppressor and the Ras proto-oncogene. LKB1 is a tumor suppressor gene and loss of LKB1 protein has been shown to predict the aggressiveness of cancer especially in the context of accompanying KRAS mutations. Strikingly, LKB1 loss is associated with greater resistance to single-agent PI3K/Akt and MEK inhibitors in non-small cell lung cancer, suggesting that LKB1 mutations have potential as predictive biomarkers and warrant further investigation prospectively in clinical trials of PI3K, Akt, mTOR and MEK pathway inhibitors. These findings provide a rationale for discerning LKB1 in the clinic since knowledge of patient LKB1 status may aid in the identification of appropriate therapies and result in significant improvement in patient survival.

According to Dr. Wong, "Understanding the status of LKB1 in a patient's cancer might help further stratify the type of treatment or clinical trial a patient should undergo. A LKB1 diagnostic test will refine personalized medicine beyond just identification of the oncogenic driver."

Under a licensing agreement with Dana-Farber, MolecularMD developed these diagnostic assays for LKB1 status in support of a variety of clinical trials exploring LKB1 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 Announces Presentations at upcoming American Association of Cancer Research Meeting

MolecularMD Corp. will present data at the annual meeting of the American Association of Cancer Research Annual Conference, April 6-10^th in Washington, D.C. These poster presentations demonstrate MolecularMD's ongoing leadership as a provider of innovative and reliable molecular diagnostic solutions.

MolecularMD AACR Poster Presentation Schedule

For additional information, please contact MolecularMD at 1-877-459-4979 or visit its website at www.molecularmd.com

About MolecularMD
MolecularMD Corporation develops and commercializes specialty molecular diagnostics for oncology applications. Its tests are designed to allow appropriate selection, monitoring and management of patients treated with molecularly-targeted cancer therapies. MolecularMD incorporates gold-standard and innovative technologies in providing its partners with the highest quality results. Assays are designed to meet clinical trial needs, and MolecularMD has appropriate systems and standards in place to enable development of companion diagnostic tests in conjunction with partners' novel anticancer agents. A private company based in Portland, Oregon, MolecularMD was founded by Dr. Brian Druker, director of the Knight Cancer Institute at Oregon Health & Science University, and Sheridan G. Snyder, entrepreneur and founder of Genzyme Corporation.