NEW YORK (GenomeWeb News) - Although 23andMe had kept mum for several months on which contract laboratory it has been using to conduct its DTC genomic testing services, GenomeWeb Daily News has learned that Laboratory Corporation of America is providing the necessary genotyping services for the personal genomics company.
Officials from both 23andMe and LabCorp have confirmed that the lab testing giant is providing the genotyping services for 23andMe's service.
“I can confirm that we are doing lab work for 23andMe,” Eric Lindblom, LabCorp’s senior vice president for investor and media relations, told GWDN.
Lindblom also noted that LabCorp is CLIA licensed in California and New York, the two states that recently warned 23andMe, along with several other personal genomics firms, to stop marketing genetic tests directly to consumers. One of the reasons cited by regulators was that the consumer genomics firms were not licensed in these states to provide laboratory services.
Perhaps due to these regulatory difficulties, 23andMe hadn’t been forthcoming about its relationship with LabCorp since cutting ties with Illumina, which was not CLIA licensed, in February. 23andMe, however, continues to use Illumina's genotyping chips.
Illumina had received one of the cease-and-desist letters from New York health regulators, but not California authorities.
23andMe expressed its apprehensions about the uncertain regulatory environment for consumer genomics in April on its blog, The Spittoon, apologizing to customers for delays in delivering test results. At the time, 23andMe attributed the delays to a change in laboratory.
“Because 23andMe is creating an entirely new kind of business in delivering personal genetic information, the regulatory requirements we face are both complicated and uncertain,” 23andMe founder Anne Wojcicki said in the blog post. “Because of the way these requirements are evolving, we recently changed the laboratory where our customers’ saliva samples are processed.”
Although Wojcicki described the new contract laboratory as a “‘high complexity’ laboratory [certified] under the federal Clinical Laboratories Improvement Act of 1988,” she did not name the laboratory.
LabCorp also has partnerships with several firms across the country that conduct genotyping services, including National Genetics Institute, which is based in Los Angeles and has CLIA certification in the state.
However, when asked why LabCorp decided to move into the controversial DTC space, when the bulk of the company’s tests are marketed to physicians, Lindblom was quick to answer that LabCorp is not a DTC genomics company.
“We are not DTC, as we are the lab for 23andMe and they are the DTC,” Lindblom said. “This is a ‘client’ just like other client arrangements we have, [including] hospitals, pharma companies for clinical trials, and employers for drug testing.”
Despite the current regulatory uncertainty in the DTC personal genomics space, an early investment in the burgeoning field may be a profitable move in the long run.
DeCode Genetics, which along with 23andMe and Navigenics received a warning letter from California health regulators for its DeCodeMe personal genomics service, has said it expects revenues from the DeCodeMe business to rival its diagnostics business.
“Somewhere in the next five or 10 years … pretty much every college-educated person in America is going to have genetic profiling of the sort that is marketed through DeCodeMe,” DeCode CEO Kari Stefansson told investors during a recent R&D update.