(Repeats for wider distribution)
By Ransdell Pierson
Aug 12 (Reuters) - Home genetics company 23andMe on Tuesday said it hopes to uncover gene mutations linked to inflammatory bowel disease (IBD) by enrolling 10,000 people with the hard-to-treat malady and examining DNA from their donated saliva samples.
The privately held company, founded in 2006 by Anne Wojcicki and backed by Google Inc, said U.S. drugmaker Pfizer Inc will support its latest research effort.
“We’re hoping within a year or two to have some meaningful genetic data and that it might lead to either an improved therapy or a new therapy for IBD,” said Catherine Afarian, a spokeswoman for 23andMe, which is based in Mountain View, California.
IBD is the catch-all term for Crohn’s disease and ulcerative colitis, painful and debilitating inflammatory conditions in which the immune system is believed to attack the bowel. They affect 1.4 million people in the United States, according to the U.S. Centers for Disease Control and Prevention.
Although there are no cures for either Crohn’s or ulcerative colitis, Pfizer is testing its approved Xeljanz arthritis pill as well as four experimental drugs against one or both conditions. The largest U.S. drugmaker does not currently sell any IBD treatments.
Pfizer and 23andMe declined to provide financial details about their collaboration, including whether Pfizer would be able to exclusively license rights to develop drugs that target any gene mutations identified in the study.
23andMe sells a $99 DNA test, from which it provides its customers ancestry-related genetic reports and uninterpreted raw genetic data.
But those enrolling in the IBD research project, who must have been diagnosed with Crohn’s disease or ulcerative colitis by a qualified physician, will receive the company’s test at no cost. They must provide a saliva sample, answer online surveys and agree to share their data with researchers. The study is only open to U.S. residents.
For more information on study: (www.23andme.com/ibd)
Until last year, 23andMe also offered reports meant to provide information about a person’s health risks, including risk assessments for certain cancers. But following objections from the U.S. Food and Drug Administration, it no longer offers that service.
In a warning letter dated Nov. 22, the FDA said products that are designed to diagnose, mitigate or prevent disease are medical devices that require regulatory clearance or approval, “as FDA has explained to you on numerous occasions.”
The agency, which had not cleared any genetic tests offered directly to consumers, said false positive tests for certain breast or ovarian cancers could lead a patient to undergo preventative surgery including mastectomy, intensive screening or other potentially risky procedures. A false negative could result in a failure to recognize and act on an actual risk.
The biggest prior research effort by 23andMe, announced in 2009, recruited more than 10,000 people to identify genetic links to Parkinson’s disease. Although two gene mutations were linked to the progressive neurological disease, they were not deemed treatable with drugs. (Reporting by Ransdell Pierson; Editing by Bernard Orr)