Companions in diagnostics

Abbott to develop companion diagnostic for a Pfizer investigational lung cancer therapy

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DES PLAINES, Ill.—In their first collaboration—in the area of diagnostics, anyway—Abbott and New York-based Pfizer Inc. announced recently that they have entered into an agreement to develop a molecular diagnostic test for screening non-small cell lung cancer (NSCLC) tumors for the presence of gene rearrangements.
The collaboration's origins began with Pfizer's development of a novel investigational agent that is intended to selectively target cancer-causing genes that have been implicated in the progression of many different varieties of cancer.
However, for patients to be eligible to receive this oral therapy from Pfizer—currently known as PF-0234106—a particular genetic translocation known to be found in NSCLC tumors, but not in normal cells, must be present. This translocation is also present in a wide variety of other cancers, notes Garry Nicholson, general manager of Pfizer's Oncology business unit.
So, to aid Pfizer in the therapeutic selection process, Abbott will, under terms of the agreement, develop a companion diagnostic test designed to determine a patient's genetic status, with the near-term goal being to use the test in patient selection for future clinical trials of PF-02341066.
Looking toward the long term, however, and an approved therapy down the road, Nicholson notes that not only is Pfizer pleased to work with Abbott to develop this companion diagnostic for trial purposes, but to "ensure its global availability for patients and physicians who need this information to make the best treatment decisions."
"This test will allow us to focus on the patient population most likely to benefit from our NSCLC candidate," he adds. "Working in close partnership with the experienced Abbott team, we are confident that we will deliver yet another application of personalized medicine to address a currently unmet medical need in NSCLC."
"Pfizer's novel compound for treating non-small cell lung cancer appears to be ideally suited to individualized therapy," says Stafford O'Kelly, head of Abbott's molecular diagnostics business, adding that his company "is a leader in the development and commercialization of companion diagnostics and we're delighted to collaborate with Pfizer, a leader in cancer therapeutics, on the development of a test to identify patients who might benefit from this important compound."
For the past decade at least, personalized medicine has been a hot topic and continues to grow in importance, and this has put increasing focus on the linking of therapeutics with diagnostic tests, notes Don Braakman, director of public affairs for Abbott.
"Abbott, through its molecular division, which is primarily a diagnostics business specializing in gene-based tests, has been in this space for a number of years," Braakman says, "most notably with HER-2 gene tests used to select potential candidates for Herceptin therapy. So we were a likely candidate for Pfizer to partner with in development of a test for lung cancer and which patients might be responsive to their therapeutic agent."
In fact, Braakman notes, it was just recently, in mid-July, that Abbott had announced a similar deal with United Kingdom-based GlaxoSmithKline PLC to develop an automated molecular diagnostic PCR-based test that will be used to screen lung cancer tumors.
Abbott is developing for GSK a test for screening non-small cell lung cancer tumors for expression of the MAGE-A3 antigen, the presence of which is necessary to receive a GSK drug candidate that is being evaluated in a Phase III clinical study. Abbott has agreed to work with GSK to develop and commercialize a PCR test to detect the antigen using its m2000 automated instrument system.
The m2000 instrument is a key platform used by Abbott's molecular diagnostic business for developing certain companion diagnostic tests, but the company also has another key technology used for such tests, which is fluorescence in situ hybridization (FISH). 
The PathVysion HER-2 test for selection of Herceptin patients, for example, uses FISH technology.
Braakman notes that Abbott has not yet disclosed which of the two technologies will be used in the Pfizer collaboration. Financial terms of the deal have not been disclosed.

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