Abbott said its molecular diagnostics business has entered into an agreement with Genentech, Inc., F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals, Inc. to develop a gene test to potentially assess the clinical benefit of Tarceva (erlotinib), an oral tablet indicated 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.
Under the agreement, Abbott will develop a test to detect extra copies of the epidermal growth factor receptor (EGFR) gene using its proprietary fluorescence in situ hybridization (FISH) technology in NSCLC. Financial terms of the agreement were not disclosed
Currently, there are no nucleic acid based tests validated or approved by the US Food and Drug Administration that could identify patients who may derive greater treatment benefits from targeted lung cancer therapies.
"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, vice president, molecular diagnostics, 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."
There have been infrequent reports of interstitial lung disease (ILD)-like events, including fatalities in patients receiving Tarceva. While receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. The most common side effects in patients with NSCLC receiving Tarceva were rash and diarrhoea.
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 labelled with coloured 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.