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Medco Offering MolecularMD Companion Dx Test for Tyrosine Kinase Inhibitor Response

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Medco Health Solutions will offer patients diagnosed with chronic myeloid leukemia a companion diagnostic test to assess their response to tyrosine kinase inhibitor, or TKI, therapy under an agreement with MolecularMD announced today.

MolecularMD's qRT-PCR BCR-ABL assay will be used to help physicians make treatment decisions and to monitor patients on TKI therapy, under the terms of the deal.

Medco is offering the test as part of the DNA Direct by Medco clinical testing program services. The pharmaceutical benefits management firm will identify patients who need the test and then secure a physician order. A blood sample will be collected, and then sent to MolecularMD's laboratory for processing. A report with a record of the patient's adherence to therapy will be sent to the patient's doctor "to assist the physician in addressing any adherence barrier that might contribute to a loss of response to therapy or drug resistance," Medco and MolecularMD said in a statement.

TKI therapy is the current standard of treatment for CML, and three TKIs have been approved as first-line therapies by the US Food and Drug Administration — Gleevec, (imatinib), Sprycel (dasatinib), and Tasigna (nilotinib). Physicians use qRT-PCR BCR-ABL testing to measure molecular response to TKI therapy.

According to the partners, more than 95 percent of CML patients have cancer genes with BRC-ABL.

"MolecularMD's test has been employed extensively in late-phase pivotal clinical trials of second generation TKIs to help demonstrate improved patient response," Jane Barlow, vice president, Clinical Innovation, of Medco, said in a statement. "Using this molecular test regularly to determine if a patient is exhibiting the appropriate response to the drug can help ensure better clinical outcomes for the patient and reduce overall healthcare costs for the health plan."

Financial terms of the deal were not disclosed.

Based in Portland, Ore., MolecularMD develops speciality molecular diagnostics for oncology. In March, it and Ariad Pharmaceuticals announced a deal to develop a companion diagnostic test to identify the T315I mutation of the BCR-ABL gene in patients with CML and Philadelphia-positive acute lymphoblastic leukemia.