Medco Health Solutions, Inc. (NYSE: MHS) and MolecularMD Corp. today announce the launch of a personalized medicine program for chronic myeloid leukemia (CML) patients. Through this program, Medco will offer patients diagnosed with CML a molecular test known as qRT-PCR (quantitative real-time polymerase chain reaction) BCR-ABL to monitor the disease.
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The current standard treatment for CML patients is tyrosine kinase inhibitor (TKI) therapy, which has demonstrated broad and robust efficacy as a targeted cancer treatment. Three TKIs have been approved by the Food and Drug Administration (FDA) for first-line therapy including imatinib (Gleevec®), dasatinib (Sprycel®) and nilotinib (Tasigna®).
The TKIs directly inhibit the activity of a genetically-altered BCR-ABL protein to suppress the cancer's growth. qRT-PCR BCR-ABL molecular diagnostic testing is used by physicians to measure molecular response and indicate potential resistance to TKI therapy. Documenting BCR-ABL levels prior to initiation of therapy and then monitoring levels during treatment allows patients and their doctors to determine how well the medicine is working for them, and make adjustments as warranted.
"MolecularMD's test has been employed extensively in late phase pivotal clinical trials of second generation TKIs to help demonstrate improved patient response," said Dr. Jane Barlow, vice president, Clinical Innovation, of Medco. "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."
MolecularMD's qRT-PCR BCR-ABL test will be offered as part of the DNA Direct® by Medco clinical testing program services. Once Medco identifies a patient in need of the test and secures a physician order, a specimen collection kit is sent directly to the patient. A blood sample is then collected by the patient's physician or phlebotomist and sent to MolecularMD's CLIA-approved and CAP-accredited facility. A full quantitative Major Molecular Response report will reference the International Scale (IS) as a method of standardization, ensuring consistency and comparability of results. The report will be supplemented with a record of the patient's adherence to therapy, to assist the physician in addressing any adherence barrier that might contribute to a loss of response to therapy or drug resistance.
The CML testing program is the tenth offering in the DNA Direct by Medco growing personalized medicine portfolio. Other tests in the program assist in either the safe dosing or efficacy of drugs such as Coumadin® (warfarin), Plavix® (clopidogrel), Nolvadex® (tamoxifen), Ziagen® (abacavir) and Selzentry® (maraviroc), as well as Home Biometric Testing for diabetes. Presently, 300 clients representing more than 10 million members are enrolled in Medco's personalized medicine programs.
BCR-ABL and Chronic Myelogenous Leukemia
More than 95 percent of CML patients (and about 45 percent of acute lymphoblastic leukemia patients) harbor cancer cells with a gene mutation called BCR-ABL also know as the Philadelphia (Ph+) chromosome which is the result of a chromosomal rearrangement. The protein produced by the BCR-ABL gene promotes cancer cell growth and proliferation, causing those Ph+ cells to crowd out normal blood cells resulting in CML. Certain CML medications, the TKIs imatinib, dasatinib and nilotinib, directly inhibit the activity of the mutated BCR-ABL protein to suppress the cancer's growth. Documenting BCR-ABL levels prior to initiation of therapy and then monitoring levels during treatment allows patients and their doctors to determine how well the medicine is working for them, and make adjustments as warranted.
National BCR-ABL Testing Guidelines
The National Comprehensive Cancer Network (NCCN) and the National Cancer Institute (NCI) agree that CML patients currently being treated with TKIs should be monitored for BCR-ABL transcript levels. Guidelines recommend BCR-ABL testing at diagnosis to establish a baseline BCR-ABL level, every three months while a patient appears to be responding to treatment, and every three-to-six months once a patient achieves complete cytogenetic response (CCR). If a patient has a rising level of BCR-ABL transcripts (enough to demonstrate a 1-log increase), guidelines call for evaluation of patient compliance, repeat testing in one-to-three months and/or an ABL kinase domain mutation analysis.
Medco Health Solutions, Inc. (NYSE: MHS) is pioneering The world's most advanced pharmacy® and its clinical research and innovations are part of Medco making medicine smarter for approximately 65 million members.
With more than 20,000 employees worldwide dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2010 revenues of $66 billion, Medco ranks 34th on the 2011 Fortune 500 list and is named among the world's most innovative, most admired and most trustworthy companies. For more information, go to http://www.medcohealth.com.
MolecularMD Corp. 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's assays incorporate both gold-standard and innovative technologies to provide highly sensitive, standardized, reliable results that support clinical development, regulatory approval, and commercialization of novel anticancer agents. A private company based in Portland, Oregon, MolecularMD was founded by Brian Druker, lead clinical investigator for Gleevec and director of the Knight Cancer Center at Oregon Health & Science University, and Sheridan G. Snyder, entrepreneur and founder of Genzyme Corporation and Upstate Biotechnology.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
SOURCE Medco Health Solutions, Inc.