A Medical Device Daily

Abbott (Des Plaines, Illinois) has entered into an agreement with Pfizer (New York) to develop a molecular diagnostic test intended to screen non-small cell lung cancer (NSCLC) tumors for the presence of gene rearrangements. Pfizer has developed a novel investigational agent that selectively targets cancer-causing genes implicated in the progress of many cancers. To be eligible to receive Pfizer's oral therapy, a particular genetic translocation (rearrangement) known to be found in NSCLC tumors and a wide variety of other cancers, but not in normal cells, must be present.

Under terms of the agreement, Abbott will develop a companion diagnostic test that will determine a patient's genetic status and will be used in patient selection for future clinical trials of PF-02341066.

"We are very pleased to partner with Abbott to develop a companion diagnostic test for non-small cell lung cancer and ensure its global availability for patients and physicians who need this information to make the best treatment decisions," said Garry Nicholson, general manager, Pfizer Oncology Business Unit. "This test will allow us to focus on the patient population most likely to benefit from our NSCLC candidate. 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," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "Abbott 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."

In other agreements and contracts news, NewCardio (Santa Clara, California), a cardiac diagnostic and services company, reported that a top-three contract research organization has signed a master services agreement (MSA) to use NewCardio's QTinno software suite as its technology in fully automated Thorough QT (TQT) and Phase 1 studies delivered by its centralized ECG core lab. NewCardio expects to collaborate on the first fully automated study, tentatively scheduled to begin during the third quarter of 2009, and it is anticipated that the customer will increasingly deliver fully automated results through QTinno in TQT/QT studies going forward.