Ancestry, the patron genetics firm that has till now centered on serving to individuals perceive their household historical past, on Tuesday revealed new merchandise that may permit shoppers to get well being info primarily based on their DNA outcomes — placing it in direct competitors with 23andMe.
Ancestry has chosen a really completely different technique than its rival. Not like 23andMe checks, that are ordered by shoppers, AncestryHealth merchandise shall be ordered by a doctor who works for PWNHealth, a New York-based nationwide community of medical doctors that claims on its web site that its mission is “to allow secure and easy accessibility to diagnostic testing.” Entry to skilled genetic counselors, additionally from PWNHealth, shall be included within the buy worth, which shall be as little as $49.
Margo Georgiadis, Ancestry’s CEO, informed STAT that “shoppers resolve” sums up the corporate’s philosophy about how and when individuals will entry genetic counselors. “It’s at all times about selection and management in that have for them. We now have actually tried to create an expertise that helps individuals digest and perceive info.”
She mentioned clients shall be proven on-line academic movies about DNA testing earlier than getting outcomes and, afterward, be given detailed on-line sources to higher perceive them. Then, in the event that they want it, they may discuss to a genetic counselor.
The truth that physicians — who is not going to initially see or straight work together with sufferers — order the checks signifies that AncestryHealth is not going to be regulated by the Meals and Drug Administration, which regulates 23andMe, however by the Facilities for Medicare and Medicaid Providers beneath the foundations for physician-ordered diagnostic checks.
“Ancestry has largely escaped a lot of the controversy that has dogged shopper genomics,” mentioned Dr. Robert Inexperienced, the director of the Genomes2People analysis program at Brigham and Ladies’s Hospital, who has been paid for consulting from different genetics associated firms. “Now by particularly taking their model into well being care, they’re inviting the controversy about completeness, about accuracy, about communication, about potential medical miscommunication, about false reassurance — all these various things that we’ve been speaking about since 2007.”
The 17 genes included within the AncestryHealth checks embody: the BRCA1 and BRCA2 genes, which improve danger of hereditary breast and ovarian most cancers; the MLH1, MSH2, MSH5, and PMS2 genes, which result in Lynch syndrome, which causes hereditary colon most cancers; the MYBPC3 and MYH7 genes, that are linked to cardiomyopathy; the APOB, LDLR, and PCSK9 genes, which may trigger familial hypercholesterolemia; the HFE gene, which causes hereditary hemochromatosis; the F2 and F5 genes, which trigger thrombophilia, a clotting dysfunction; and the genes that trigger sickle cell anemia and cystic fibrosis.
The take a look at may also embody outcomes on traits like lactose intolerance and caffeine metabolism, which some consultants informed STAT weren’t crucial or acceptable.
Some mentioned that the variety of genetic ailments about which the take a look at will present info is low, and that it’s not clear how affected person counseling will work. Additionally they mentioned they’ve questions on how Ancestry will use the info.
“What individuals don’t get is that genetics are a tiny piece of the puzzle,” mentioned Dr. David Agus, a professor on the College of Southern California who was an early pioneer in shopper genetics. He factors to a statistic that comes from Ancestry’s personal analysis: In an enormous examine performed with Google (GOOGL) and printed within the scientific journal Genetics, genes accounted for lower than 10% in variations in how lengthy individuals lived.
Laura Hercher, the director of analysis in human genetics at Sarah Lawrence School, mentioned that solely 2% of sufferers who wouldn’t have a household historical past of illness can be anticipated to study one thing medically necessary from studying about their genomes.
“Some individuals will get medically helpful info from this,” Hercher mentioned. “For many, the concept DNA testing will assist your physician information your well being selections is an overstatement.” She referred to as that promise “untimely at greatest.”
Ancestry shall be advertising the checks to the 15 million individuals who have already ordered kits to seek out out about their household historical past, along with new clients.
The corporate can have two merchandise. AncestryHealth Core shall be a one-time service that may yield information primarily based on a DNA microarray, a lot as 23andMe does. It would price $49 for present clients, in comparison with $149 for a 23andMe take a look at for well being traits. This take a look at will return outcomes as soon as.
AncestryHealth Plus will use next-generation DNA sequencing know-how to ship extra detailed info to shoppers. Initially, it is going to deal with the identical 17 disease-associated genes centered on by AncestryHealth Core. It would price $199, after which shoppers might want to pay a $49 subscription payment each six months with a purpose to proceed getting quarterly updates on their genetic info.
Technically, the AncestryHealth Plus will contain sequencing a sufferers’ exome, the scientific time period for all the recognized genes that code for proteins within the physique. However Ancestry has determined to return to customers solely a small quantity of the ensuing info.
Dr. Eric Topol, director and founding father of the Scripps Analysis Translational Institute, mentioned the American School of Medical Genetics recommends that dangerous mutations in 58 genes ought to be disclosed to individuals after sequencing is performed. He famous that Geisinger Well being, in its exome sequencing efforts, does this. “It’s minimal,” he wrote of the AncestryHealth Plus take a look at. He referred to as it “a step in the correct route, however not consistent with consensus and follow within the medical neighborhood.”
Catherine Ball, Ancestry’s chief scientific officer, mentioned that the choice to deal with extremely actionable ailments outcomes from Ancestry’s efforts to grasp the wants of its clients and the first care physicians who might want to assist them react to their take a look at outcomes. The important thing, she mentioned, was to incorporate solely checks that may “enhance outcomes for our clients and for his or her households.”
One huge query for sufferers shall be whether or not they need to be getting a special take a look at than the one they select. For sufferers who need a BRCA1 or BRCA2 take a look at as a result of that they had a household historical past of breast most cancers, the AncestryCore take a look at will solely inform them if there’s a frequent “misspelling” within the gene — which means that many mutations that would trigger most cancers can be missed. The brand new AncestryPlus take a look at can be extra more likely to decide up an issue if it exists. However the affected person is likely to be higher off with a medical take a look at like those made by Myriad Genetics (MYGN) or Shade Genomics, which could even be lined by insurance coverage. One of many largest dangers, consultants mentioned, is that sufferers will wrongly suppose they’re at low danger due to an incomplete genetic take a look at.
“The danger, as with the opposite shopper genomics, is that sufferers will suppose that is one way or the other a complete and encyclopedic investigation of your complete genomic well being,” mentioned Inexperienced, of the Brigham. However he argued: “Discovering some people who find themselves carrying vital and actionable mutations is healthier than discovering none of them.”
One other problem is how the info shall be used if sufferers consent to analysis. Can privateness be fully protected? Ancestry mentioned it doesn’t promote shoppers information, even in an aggregated and anonymized type, however it could do analysis with companions.
One downside for sufferers is that there’s merely a lot info. Greater than a decade in the past, Agus co-founded an organization referred to as Navigenics, which was an early competitor to 23andMe. From the beginning, not like 23andMe, Navigenics utilized genetic counselors to make it possible for sufferers understood the outcomes they have been getting.
Shortly after launch, Agus remembers getting a name from Steve Jobs. “Agus, you screwed up,” Jobs mentioned. “What do you imply?” Agus requested. Jobs replied: “You may’t inform anyone 30 issues without delay. The human mind turns off.”
Ancestry, like different genetic testing firms, has additionally needed to decide how greatest to inform sufferers unhealthy information — equivalent to that one has a really excessive danger of breast most cancers or ovarian most cancers, and will think about a mastectomy and ovary elimination. Dorothy Pomerantz, a supervisor at a boutique content material agency, lately wrote for STAT in regards to the bracing expertise of studying about her BRCA standing after taking a 23andMe take a look at.
After reviewing Ancestry’s supplies, Pomerantz was inspired by the steps the corporate is taking.“They’re at the least attempting,” she mentioned.
“They’re placing an emphasis on genetic counselors and their relationships. But it surely’s laborious to inform what occurs while you sit right down to do it.”
The satan, Pomerantz mentioned, shall be within the particulars.
An earlier model of this story mentioned that AncestryHealth Core will price $49. It would price $49 for present clients.