Since July 2009, the companies have been working to develop a polymerase chain reaction (PCR) test to screen non-small-cell lung cancer (NSCLC) tumors for expression on the MAGE-A3 antigen, a tumor-specific antigen that is expressed in a large variety of cancers. Under their expanded agreement, Abbott will develop a PCR test for use on the company's m2000rt instrument to screen NSCLC tumors for the expression of the PRAME antigen, a preferentially expressed antigen of melanoma that is expressed in 69 percent of NSCLC cases. The new agreement brings other varieties of cancer into the fold—including melanoma, breast, ovarian and bladder cancer—that have limited expression in normal cells.  

 

Ultimately, the companies hope Abbott's diagnostics will be used in antigen screening as a first-phase diagnostic for patients. The diagnostics will support GSK's Antigen Specific Cancer Immunotherapy (ASCI) program, which is comprised of a class of novel compounds based on tumor antigens presented to the patient's immune system as recombinant proteins in combination with a GSK proprietary adjuvant system. ASCIs are meant to trigger a specific immune response against tumor cells expressing these proteins, rallying antibodies and T-cells to recognize and attack the cancer cells in a highly specific manner—and eventually eliminate them.  

 

According to GSK, this approach aims to reduce the risk of tumor recurrence following surgery. It could also be used to impact tumor growth in early metastatic settings. The ASCIs' highly targeted mode of action may also avoid harming normal tissue, says GSK, and it may also allow selection of patients eligible for treatment depending on the expression of the tumor antigens. In the end, this may help oncologists to select patient populations most likely to respond to treatment, says GSK.  

 

"So once MAGE-A3 is approved and on the market, each patient would have their biopsied tumor sample tested as a first step using the Abbott-based platform as a first-phase diagnostic for patients, and then as a second step using Life Technologies for gene signatures as a second stage of the patient profiling," explains Sarah Clarkson, a spokeswoman for GSK Vaccines.

 

Indeed, GSK has been very attracted to Abbott's expertise in developing diagnostic tests, Clarkson adds.

 

"One of the reasons GSK partnered with Abbott is that we not only have experience with development and filing for regulatory approvals, but we have had a global commercial reach. We have also had successful partnerships with Pfizer, Roche/Genentech and AstraZeneca," says Kathryn Becker, director of Abbott Molecular's oncology business. Considered a pioneer in the use of molecular tests based on PCR and fluorescence in-situ hybridization (FISH) technologies to aid clinicians in the selection of appropriate pharmacogenomic therapies, Abbott's overall strategy and focus is "to create novel molecular diagnostics to improve patient care, including diagnosis, prognosis and prediction of therapeutic response," says Becker. 

 

"In particular, in the past two years, we have been concentrating on the field of companion diagnostics," she says. "There haven't been many successful biomarkers in oncology. Their efficacy is about 25 percent. With good science and biomarkers, we will continue to partner with pharmaceutical companies to help identify and deliver novel tests and therapies to patients around the world."  

 

Financial details of the companies' agreements were not disclosed.