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Medco Taps MolecularMD to Provide BCR-ABL Testing for TKI Inhibitors in CML Patients

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Originally published June 3.

By Bernadette Toner

Medco Health Solutions has added BCR-ABL testing to its personalized medicine portfolio, marking the tenth such offering under its DNA Direct clinical testing program.

The company said this week that it will offer MolecularMD's qRT-PCR BCR-ABL test to patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in order to monitor their response to tyrosine kinase inhibitors such as imatinib (Novartis's Gleevec), dasatinib (Bristol-Myers Squibb's Sprycel) and nilotinib (Novartis's Tasigna).

More than 95 percent of CML patients harbor a mutation in BCR-ABL, which is also called the Philadelphia chromosome. The protein produced by the BCR-ABL gene promotes cancer cell proliferation, and TKIs such as Gleevec, Sprycel, and Tasigna inhibit the activity of the mutated BCR-ABL protein to suppress the cancer's growth.

The National Comprehensive Cancer Network recommends BCR-ABL testing in CML patients 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.

Separately, Ariad Pharmaceuticals is using MolecularMD's ABL kinase domain sequencing technology to pick out best responders to its investigational BCR-ABL inhibitor ponatinib in the so called Ponatinib Ph+ ALL and CML Evaluation, or PACE trial. Using the test, researchers will give the drug to patients with mutant forms for BCR-ABL who are intolerant or resistant to Sprycel or Tasagnia or developed T315I mutations after receiving any tyrosine-kinase inhibitor, including Gleevec (PGx Reporter 03/30/2011).

Jane Barlow, vice president of clinical innovation at Medco, said in a statement that using BCR-ABL testing 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."

Barlow told PGx Reporter that even though NCCN recommends quarterly BCR-ABL testing for patients taking TKIs, many physicians do not comply with these guidelines.

Medco researchers recently examined medical claims records of 359 CML patients who were treated with Gleevec and found that only 60 percent had evidence of at least one test performed at any time over the last one and a half years, while only 14 percent had BCR-ABL testing recorded on a consecutive quarterly basis.

"These findings are important in that regular BCR-ABL monitoring is needed to avoid delay in key decisions about CML treatment, as well as to help insure the best treatment outcome possible," Barlow said.

The company decided to launch the BCR-ABL testing program in order to address this "gap in testing to evidence-based guidelines," and also because "strict adherence to these medications is critical to the success of the treatment and thus can be life saving," Barlow said.

Medco will offer MolecularMD's BCR-ABL test as part of its DNA Direct clinical testing services. Once the pharmacy benefits manager identifies a patient in need of the test and secures a physician order, it will send a specimen collection kit directly to the patient. The patient's physician or phlebotomist then collects a blood sample and sends it to MolecularMD's CLIA-approved and CAP-accredited facility, where the test is performed.

MolecularMD will provide a quantitative report that will reference the International Scale, an internationally accepted standard for monitoring BCR-ABL transcript levels in CML patients. The report will also include information on the patient's adherence to therapy, which will assist the physician in "addressing any adherence barrier that might contribute to a loss of response to therapy or drug resistance," Medco said.

Barlow told PGx Reporter that the company is partnering with MolecularMD for BCR-ABL testing because of the company's "experience in this field," and the fact that the firm has "been at the forefront of research related to these medications and BCR-ABL testing."

MolecularMD founder Brian Druker, director of the Knight Cancer Institute at Oregon Health & Science University, led the clinical trials of Gleevec for CML.

Barlow also cited the fact that MolecularMD tests to the International Standard, "which allows for a more accurate comparison of test results from the same and different labs that also use the international standard."

Other companies offer laboratory-developed BCR-ABL tests, including Roche, Qiagen, and the Laboratory Corporation of America. Last year, Gleevec manufacturer Novartis began collaborating with Cepheid to develop a PCR-based BCR-ABL test on Cepheid's GeneXpert system that will also be compliant with the International Scale. The partners said they plan to seek clearance for the test through the US Food and Drug Administration, which would make it the first BCR-ABL test to gain FDA approval (PGx Reporter 10/13/10).

— Turna Ray contributed reporting to this article.


Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at btoner [at] genomeweb [.] com.

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