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Genetic testing evolves, along with health and ethics debates – Los Angeles Times

When last we visited with the genetic testing firm 23andMe, it was in huge trouble.

That was keep away from 2013. The Food and Drug Administration had just ruled that the organization had been breaking the law in marketing the Personal Genome Service. For $99, customers spit into a tube, sent it to 23andMe and got back a report on their carrier status or susceptibility to breast cancer, heart disease and several 250 other diseases or problems, based on genetic information extracted using their saliva.

The FDA described the program as an unlicensed medical device and ordered it off the market. The warning letter implied that the Hill View, Calif., company hadn’t already been straight with regulators and had been ignoring demands for data proving its service was accurate. Professionals in the genetics testing field pondered whether the tests — and the organization itself — were ready for best time.

As of mid-October, 23andMe is back in the direct-to-consumer genetic testing business. (The firm’s title refers to the 23 chromosome pairs in the human genome. ) It’s selling a different product, one that doesn’t raise the consumer education or health and safety issues that motivated the FDA’s action. Its relationship with the agency seems to be much better too.

That doesn’t mean that you can actually new businesses are entirely free of consumer and safety concerns. Its initiatives to exploit its growing database of customer genomes, now numbering 1 million subjects, by selling it to drug companies and launching a drug-development program of its own could raise privacy concerns.

a discussion paper last December. The challenge is only going to grow, as new, innovative companies enter the market.

Consider Theranos, a Palo Alto start-up with an ostensibly new way of drawing blood whose effectiveness and reliability have come under FDA scrutiny. Theranos and 23andMe are usually in different businesses but share an evangelical marketing pitch built close to individuals’ right to access their private medical data without the intervention of a physician. The attitude can ensemble regulators and the medical establishment in the role of hidebound protectors of entrenched interests, rather than guardians of public safety — which makes the particular regulator’s job that much more complicated.

Yet the change in the consumer service now being sold by 23andMe — for the higher price of $199 — is at least an implied acknowledgment that the FDA was directly to shut down the old one.

Originally, customers were given a report detailing their relative susceptibility to hundreds of diseases based on the presence of gene variants detected in their DNA.

This raised several issues: The role of genetics in certain conditions may be marginal or conjectural. With such multifaceted conditions as cancer or heart diseases, a person’s behavior and lifestyle probably have much more to do with disease risk than one’s genes. These considerations might have evaded many consumers despite extended 23andMe disclaimers. The FDA terrifying that consumers might be misled into undergoing expensive tests or surgeries for conditions they didn’t actually face.

The company’s new program, which has received the FDA’s general blessing, focuses chiefly on “carrier status” — the presence of the gene variant that could affect the health of one’s offspring, especially if they inherit the same variant from a second parent. The service covers 36 problems known to be linked to the inheritance of recessive genes, including Tay-Sachs disease, cystic fibrosis and sickle-cell anemia.

Instead of assessing the customer’s own health or disease risk — which are uncertain — the particular service has been remade into a device for “adults contemplating having a loved ones or looking at what could be passed on to future generations, ” Web page says. That’s a much simpler statistical computation — the child of two moms and dads each carrying a specific recessive gene is known to have a 25% chance of getting the gene from each parent and therefore inheriting the disease, a 25% possibility of not inheriting the gene at all, and a 50% chance of inheriting the particular gene from one parent and thus being a carrier, but not contracting the disease.

That turns the program into a family-planning tool similar to that routinely provided to prospective moms and dads by genetic counselors. Indeed, the particular FDA required 23andMe to give clients information on finding genetic counseling included in its reports. The firm’s reviews also give customers more innocent data, including windows into their genetic ancestry, their predisposition to four “wellness” conditions such as lactose intolerance, and such personal traits as eye color, baldness and dimples.

Then there’s the firm’s entry to the sales of its customer database in order to drug companies and its own initiatives to develop treatments for gene-based problems. These ventures conceivably could come to dominate the firm’s business; the revenue from a deal with the biotech company Genentech will yield just as much as $60 million. The company says just about all customers are asked to choose in to an anonymized and aggregated database, and more than 80% achieve this.

The narrower concentrate of the company’s new consumer program may not quell the debate more than how much medical data is healthful for individuals to have about themselves, and who should interpret it.

“I disagree with the tradition that says more information is always good, ” says Brian Zikmund-Fisher, a specialist on bioethics at the University of Michigan. “Providing people with more information is not helpful if they can’t do something about it, or it leads these to focus on the wrong thing” — on their genes rather than their lifestyles, by way of example.

Yet “it makes no sense to have a physician as being a barrier” to obtaining such information on one’s genetic makeup, says Jesse B. Agus, a professor of medicine and engineering at USC and co-founder of the genetic testing company Navigenics. Even information about marginal genetic risks for common problems such as heart disease can persuade sufferers to take better care of themselves, states Agus, author of “The Lucky Years, ” a forthcoming guide about new healthcare technologies.

The FDA has cast the vote for more access. “In several circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information, ” the particular agency ruled in February.

Nor should anyone become surprised if 23andMe or the competitors eventually return to providing clients with a lot more data. The current program, Page says, is “a launching-off point for lots of information we’d hope to provide in the future. ”

Michael Hiltzik’s column appears every Sunday. His new book is “Big Science: Ernest Lawrence and the Invention That Launched the Military-Industrial Complex. inch Read his blog every day from latimes. com/business/hiltzik, reach him from mhiltzik@latimes. com, check out facebook. com/hiltzik and follow @hiltzikm on Twitter.

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