Dive Brief:

• Ancestry announced Tuesday it's getting into the genetic health testing space with the launch of a two-tiered AncestryHealth platform positioning it to challenge 23andMe's efforts to dominate the consumer testing marketplace.
• But the company doesn't plan to pursue engaging FDA directly the way 23andMe has, instead opting to partner with clinical labs including Quest Diagnostics and Illumina to sell physician-ordered tests for genes related to risk of heart disease, certain hereditary cancers, blood disorders and other conditions, Sarah South, Ancestry vice president of laboratory sciences, told MedTech Dive.
• Consumers can buy into the Ancestry platform, though a doctor's order is required for the test itself. Ancestry is partnering with physician network PWN Health to screen individuals before a physician orders a test. Once the laboratory developed test is run, the results will be delivered back to the ordering physician to review before information is released to the consumer via the Ancestry portal or a telephone call.

Dive Insight:

With FDA recently increasing its scrutiny of genetic tests that claim to predict individual patient responses to specific drugs, Ancestry doesn't plan to offer any pharmacogenomic tests at launch.

"None of the conditions that we've discussed at launch are pharmacogenomics-based tests and we do recognize their concern," South said. "We did want to release this in a physician-ordered manner so that we would have support from the health ecosystem."

Once test results are returned, genetic counseling support will be made available through PWN.

"There are online tools where they can submit questions and read frequently asked questions," South said. "There are also real-time webinars that have confidential one-to-one chats with a genetic counselor so they can be learning information and asking questions in a confidential manner."

The first tier of Ancestry's foray into the testing space, named AncestryHealth Core, will use genotyping array technology and cost $149 for new customers or $49 for existing AncestryDNA customers.

The second tier, AncestryHealth Plus, will use next generation sequencing technology, starting in early 2020, and include quarterly screening, additional educational resources and other tools. Initially, it will cost $199 for new customers with an additional $49 membership fee every six months. Existing AncestryDNA customers can join the second tier for an initial payment of $49, an additional fee of $49 when NGS is added, along with the $49 six-month membership fee.

Conditions in the launch products include hereditary breast and ovarian cancer, hereditary colorectal cancer, two genes associated with an increased risk for hypertrophic cardiomyopathy or dilated cardiomyopathy, familial hypercholesterolemia, hereditary schema comatose, thrombosis, earlier increased risk for blood clots, and three carrier conditions, sickle cell anemia, cystic fibrosis and Tay Sachs disease, South said.

In the vast majority of situations, test results will likely be uploaded to its online portal.

"PWN would be the one that that determines the initial best way to present the information based on what that information is," South said. "For the majority of situations, we're looking for a supportive way to transmit that information when the person is has the time to absorb it and the privacy that they may want in that situation."

An Ancestry spokesperson said the company will not be billing insurance companies, saying it's up to customers to contact insurance companies to determine if individual policies will reimburse for the services.

PWN Health's frequently asked question page notes not all test requests are approved.

"Denials of specific tests stem from many different reasons: some tests aren't appropriate for some individuals (e.g. PSA test for a woman); some adhere to specific clinical guidelines, and some utilize full protocols to establish whether or not an individual is eligible," it said.

Ancestry doesn't currently have a relationship with LabCorp but it will be working with Quest Diagnostics and Illumina, South said. It's not clear how much new business Quest will gain from the relationship.