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Dx Focus Jun 2, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News


Roche and Clovis Oncology said this week that they have entered into an agreement to develop an in vitro PCR-based companion diagnostic test to identify activating epidermal growth factor receptor mutations, including the EGFR T790M mutation, in patients with non-small cell lung cancer.

The Cobas EGFR mutation assay will run on Roche's Cobas 4800 System, a fully automated laboratory testing platform. The Cobas 4800 was recently approved in the US and all countries accepting a CE mark for use with the company's PCR-based test for human papillomavirus.

Clovis, based in Boulder, Colo., is interested in developing the companion diagnostic for its CO-1686 compound, currently in preclinical development for advanced NSCLC patients.

"By incorporating a companion diagnostic during clinical and commercial development of CO-1686, we reinforce our commitment to focus development programs on specific subsets of cancer populations that are most likely to benefit from our targeted therapies," Patrick Mahaffy, president and CEO of Clovis Oncology, said in a statement.

Medco Health and MolecularMD said this week that they have launched a personalized medicine program for chronic myeloid leukemia, under which Medco will offer to patients MolecularMD's qRT-PCR test for BCR-ABL to monitor the disease.

MolecularMD's qRT-PCR BCR-ABL test will be offered as part of the company's DNA Direct clinical testing program service. 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 as a method of standardization, ensuring consistency and comparability of results, the companies said.

Tyrosine kinase inhibitors, the current standard for CML treatment, directly inhibit the activity of a genetically- altered BCR-ABL protein to suppress the cancer's growth. Physicians can use qRT-PCR-based molecular testing of BCR-ABL to measure molecular response and determine potential resistance to TKI therapy.