This story has been updated to include comments from Roche.
Merck will use Roche's microarray-based AmpliChip p53 test for research purposes, Roche Molecular Systems said last week.
The collaboration is the first time Roche will make the AmpliChip p53 test available to an external partner, according to a Roche spokesperson. The company has used the assay internally in its own research programs, the spokesperson told BioArray News this week.
The chip, which is manufactured by Affymetrix, is designed to detect mutations in the tumor suppressor gene p53. The test could potentially lead to better treatment outcomes for cancer patients by determining which patients would most likely respond to investigational drug candidates, Roche said.
Eric Rubin, vice president of oncology at Merck Research Laboratories, said in a statement that the company will use the investigational AmpliChip p53 test to "discover and develop innovative cancer therapeutics." Specifically, Merck subsidiary Merck Sharp & Dohme will apply the AmpliChip p53 test in selected clinical trials to "identify those patients most likely to respond to specific therapeutic regimens in development," Rubin said.
According to the Roche spokesperson, work with Merck could lead to the eventual commercialization of the AmpliChip p53. "Until we see the results of the clinical trials, it is too soon to tell whether we would commercialize the investigational AmpliChip p53 test," she said.
Additional terms of the alliance with Merck were not disclosed.
Roche has developed several AmpliChip tests. One, the AmpliChip CYP450 test, is a pharmacogenetic test for analysis of the CYP2D6 and CYP2C19 genes, both of which influence drug metabolism. The AmpliChip CYP450 test was cleared by the US Food and Drug Administration for clinical use in 2004. The company has also developed an AmpliChip for subtyping leukemia patients (see BAN 3/7/2006).
According to the Roche spokesperson, the AmpliChip p53 test is "intended for investigational use as a companion diagnostic test in cancer clinical trials," and the company has not yet decided to submit the test to the FDA for clearance.
Roche could not provide information on its other AmpliChip tests in time for this publication.
Until it inked the deal with Merck, Roche had solely used AmpliChip p53 internally. The test is designed to detect damage to p53 DNA in tumor cells in order to identify which cells carry dysfunctional p53 proteins that can lead to cancer treatment resistance. By identifying cancers that harbor a dysfunctional p53 gene, the company "aims to achieve better treatment outcomes in cancer patients by determining which patients are most likely to respond to certain investigational therapeutic candidates," according to the spokesperson.
One of the programs where Roche is using the AmpliChip p53 test is an MDM2 inhibitor program, she said. MDM2 proteins are considered to be partly responsible for regulating the function of p53 proteins. Disruption of the normal function of either of these proteins by genetic mutations or environmental cell conditions can encourage tumor progression, the spokesperson noted.
By using the AmpliChip p53 test in its investigational MDM2 inhibitor program, "Roche intends to gain a deeper understanding of how new therapeutics in development in this area can better meet the needs of cancer patients," she said.