Abbott Laboratories (Abbott Park, Illinois) is attempting to build its library of tests that allow doctors to personalize therapy for cancer patients with a new collaboration focused on bringing to market a test to assess the clinical benefit of Tarceva (erlotinib), a drug for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

Abbott has partnered with Genentech (South San Francisco, California), F. Hoffmann-La Roche (Basel, Switzerland) and OSI Pharmaceuticals (Melville, New York) to develop the gene test based on knowledge gained by its PathVysion HER-2 DNA Probe Kit, a test used to help select women with metastatic breast cancer that could benefit from Herceptin therapy.

In 2005, the latest year for which data were available, the PathVysion assay was used for 20,000 breast cancer patients in the U.S. who are candidates for Herceptin, a targeted cancer therapy. PathVysion is a DNA-based test that detects extra copies of the HER-2/neu gene.

The new test would be able to predict response to Tarceva for the sickest lung cancer patients, Jeff Huff, an associate research fellow at Abbott who is focused on pharmacogenomics, told Medical Device Daily.

“It would be able to stratify patients or indicate their response to the drug,” Huff said.

As part of the agreement, Abbott will develop the test to detect extra copies of the epidermal growth factor receptor (EGFR) gene using its fluorescence in situ hybridization (FISH) technology in NSCLC.

Financial terms of the agreement were not disclosed.

FISH technology provides the ability to see multiple chromosomal abnormalities simultaneously in a single cell and to visually assess these genetic abnormalities in patient specimens. FISH-based tests use DNA probes labeled with colored fluorescent tags that bind to specific gene sequences on human chromosomes. These probes can reveal amplification of gene copy number or the rearrangement of large genetic structures, two genetic abnormalities that underlie certain cancers and other medical conditions.

Currently, there are no nucleic acid-based tests validated or approved by the FDA that could identify patients who may derive greater treatment benefits from targeted lung cancer therapies, according to Abbott.

“By helping to unlock the information found at the molecular level in each person’s DNA, we believe that molecular diagnostics hold the promise of personalized medicine,” said Stafford O’Kelly, VP, molecular diagnostics at Abbott. “Our goal through this important technology is to improve the practice of medicine by helping to reduce risk, produce targeted cures, and improve the detection and prevention of serious illnesses.”

Abbott and its partners chose Tarceva and non-small cell lung cancer because, Huff said, there is “very strong science supporting the potential utility.”

The test would detect gene amplification in one of two ways: by numbers of extra copies of the gene or polyploidy, with multiple copies of the chromosome,” Huff said, adding that the data would be gathered from a patient’s tumor biopsy tissue.

Tarceva is a small molecule designed to target the human epidermal growth factor receptor (HER1) pathway, which is one of the factors critical to cell growth in non-small cell lung and pancreatic cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell.

Lung cancer is reported to be the single largest cause of cancer deaths in the world, responsible for 17.6% of all cancer deaths, according to the American Cancer Society (Atlanta).

Huff said development of similar tests which encourage personalized medicine are likely to continue in the area of oncology.

“We’re very excited about this test because we believe this is a new entry into personalized medicine beyond [the] HER-2/neu gene,” Huff said. “We’ve seen FISH work well for that and this is an extension of that into another set of targeted therapies.”