23andMe, the consumer genetics company brought to a halt by the Food and Drug Administration (FDA) for ignoring repeated questions, is being conciliatory.
23andMe is the only well-known consumer genetics company offering comparatively extensive medical genetic data directly to patients. It offered raw gene data, and interpretative reports, to the general public on more than 240 diseases and traits until December 5, when it announced it would cease taking new customers as a result of FDA action.
However: “the company is now writing conciliatory letters to regulators,” says an FDA insider.
Not everyone is unhappy. Many doctors feel consumers shouldn’t be buying their own genetic information unless it is filtered for them personally by qualified professionals. Says Daniel Hayes, co-chair of the American Society of Clinical Oncology’s Expert Panel for Tumor Marker Practice Guidelines: “I personally think direct-to-consumer marketing of devices that may have potentially important clinical implications is a mistake. If it is done in a medically supervised manner with accredited genetic counselors, then I am in favor.”
But in that case, he notes, “I don’t consider that direct-to-consumer.”
The direct-to-consumer genetics field, while new, has already seen casualties: Navigenics, deCODEme, and Pathway dropped out of the consumer end of the business. 23andMe has since been joined by FamilyTreeDNA and ConnectMyDNA—but neither offers the same swath of medical data.
23andMe was viewed as able to go the distance. It was co-founded in 2006 by Ann Wojcicki, wife of Google co-founder Sergey Brin, who Forbes calls the 14th richest person in America. Brin invested $10 million in 23andMe. All told, the company has raised $161 million, and has 500,000-plus customers.
The couple separated recently, but their ties are close. They have two children. Brin started Google in the garage of Wojcicki’s sister.
23andMe offers an historic amount of data on the cheap. For $99, consumers get a read-out of hundreds of single nucleotide polymorphisms (SNPS), which are often distantly connected to predilections for certain diseases, traits, and ancient ancestral lineages. Among the genetic predispositions 23andMe offers data on are: baldness, memory skills, infertility, intelligence, Alzheimer’s, breast cancer, colon cancer, height—and dandruff.
But 23andMe stopped offering health-related genome analyses to new customers after the FDA sent its recent warning that it had ignored too many demands for information about its product. As the company offers “health reports,” it falls under FDA regulations. The FDA wrote it is important the company prove its data is accurate. As an example, it said that false breast cancer positives could lead patients to undergo unnecessary surgery.
Shortly after the company received the letter, a $5-million class action lawsuit was launched in California by consumers claiming false and misleading advertising.
Defenders note there are many steps between 23andMe and surgery. Daniel Rokhsar, a genetics professor at University of California Berkeley, is among many who note the website takes many precautions. He blogged the company impressed him with its frank warnings to consumers about the limitations of its tests. Most diseases and traits are caused by many different genes. Most of the 23andMe tests only point to vague links. But, Rokhsar blogged, the company seems up front about this.
“Any customer who signs, and hopefully reads, the disclaimers on the 23andMe website should appreciate that the reports are only a step or two beyond recreational genomics, to be taken with a shaker of salt. I, for one, was impressed with the company’s effort to educate customers about our limited ability to interpret genetic data. But 23andMe didn’t need to convince me. It needed to convince the FDA.”
Rokhsar offered links to sites that interpret raw data. “Even though 23andMe stopped providing (new) health reports until the FDA is satisfied, they do still provide the highly accurate raw A’s, C’s, G’s and T’s (nucleotides), which third party sites—presumably not subject to FDA regulation—can interpret (Interpretome is free, Promethease charges a few dollars).”
In her statement, Wojcicki said 23andMe uses the same methods as companies conducting physician-ordered tests. "Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988—known as CLIA. These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data.”
She continued: “Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization. Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had.”
Last week, Wojcicki publicly confirmed off-the-record reports the company is making amends. "We failed to communicate proactively," she said at a Fortune event in New York.