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Merck to Use Roche AmpliChip p53 Test in Clinical Trials

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Roche Molecular Systems said today that it will provide Merck subsidiary Merck Sharp & Dohme with access to its microarray-based AmpliChip p53 test, currently under development at Roche.

Under the research collaboration, Merck will apply the AmpliChip p53 test in selected clinical trials to identify patients most likely to respond to specific therapeutic regimens in development at the company, Eric Rubin, vice president of oncology at Merck Research Laboratories, said in a statement.

The AmpliChip p53 test, which combines Roche's PCR technology with Affymetrix's high-density microarray technology, is designed to detect damage to p53 DNA in tumor cells to identify which cells might have dysfunctional p53 and thus resist treatment.

The p53 protein is a key component of normal cell response to various stressors including damaged DNA. It functions by activating DNA-repair proteins, inducing growth arrest for repair of DNA damage, and initiating apoptosis when that damage is irreparable.

When p53 function is deficient, a cell's response to DNA damage is severely impaired, contributing to tumor growth and increasing the resistance of tumor cells to chemotherapy.

"Roche designed its investigational AmpliChip p53 test to rapidly provide clinically important information that can be used early in pharmaceutical development to help predict cancer patient responses to certain therapeutic candidates," Paul Brown, president and CEO of Roche Molecular Diagnostics, said in a statement.

"Roche is excited to enter into this collaboration with Merck because of the potential this test has to improve cancer patient response to treatment," Brown added.

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