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| 23andMe CEO Anne Wojcicki |
Controversial genetic testing company 23andMe is finding new ways to stay relevant after the FDA yanked its popular--and once lucrative--direct-to-consumer diagnostic from the market in 2013.
The company's collaboration with Pfizer ($PFE) to study the genetic profile of patients with lupus has just kicked off. The duo hopes to enroll 5,000 consenting patients with lupus in the cohort, which will be followed for one year. Recruitment is expected to be completed by mid-2016. Information about the participants' genetic information, medical history and responses to survey questions will be gathered and analyzed.
"The ability to effectively personalize treatments for lupus patients is limited, due in large part to our incomplete understanding of the disease," said 23andMe CEO and co-founder Anne Wojcicki, in a statement. "We hope to change that by studying human genetics alongside environmental and health history factors to ultimately help inform better treatment options for lupus patients."
Lupus is an autoimmune disease in which the immune system attacks healthy tissue in the body. Affecting more than 1.5 million people in the U.S., the condition can cause inflammation, skin rashes and sores, as well as kidney, heart and lung damage.
Pfizer is an active participant in Lupus research. Last month it teamed up with Merck KGaA to fund a related effort to analyze the genome of lupus patients. The researchers will aim to identify biomarkers and discover targets for potential therapies, dissecting the cause behind damaging lupus-related kidney flares.
In addition, the company has two Phase I and two Phase II lupus candidates in the pipeline. The Phase II candidates inhibit either the IL-6 or the JAK gene. "By enhancing our understanding of the underlying biology of the disease, we hope to better support our clinical research activities and development programs," said Belen Carrillo-Rivas, Pfizer's head of R&D in biotherapeutics, in a statement.
The lupus collaboration was announced in January. It is part of a broader collaboration between the two companies, under which 23andMe agreed to sell its existing DNA data on 650,000 individuals to the pharma bigwig.
23andMe has data sharing partnerships with several other Big Pharma companies, including one with Genentech focused on Parkinson's patients that will yield the genetic testing company up to $60 million. It also previously collaborated with Pfizer on a study of irritable bowel disease.
The Big Data-leveraging strategy of collaboration is helping 23andMe overcome a fierce FDA warning letter in 2013 that forced it to yank its popular Personal Genome Service from the market. The $99 test was said to be able to identify a number of key genes based on a small sample of saliva. 23andMe continues to sell a DNA test to consumers for determining family history.
The FDA is implementing plans to play a greater role in the regulation of diagnostics, which means other tests, including direct-to-consumer ones are likely to face tougher scrutiny in the future. But last year the agency did grant its blessing to 23andMe's direct-to-consumer genetic carrier test for Bloom syndrome.
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