FRANKLIN LAKES, N.J. and
PORTLAND, Ore., June 2, 2011 /PRNewswire/ -- 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.
(Logo:
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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.
About Medco
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.
About MolecularMD
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.