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Consumer Genomics Firms Confused by California's Actions; State Seeks Federal Solution

NEW YORK (GenomeWeb News) – Consumer genomics firms that offer tests directly to the public were left confused and frustrated last week after the California Department of Public Health sent letters to 13 firms telling them to stop offering their services to the state’s residents or face possible legal action.
California told the companies that they do not comply with two laws, one stating that these tests must be ordered by physicians and another that the labs conducting them must be licensed by the state.
But the state has not made clear yet exactly what it expects of these firms in order to remedy the situation, two of the companies told GenomeWeb Daily News this week.
By going after consumer genomics companies, California followed a trail blazed by New York, which in April sent similar letters to 23 companies saying that they needed to obtain a permit to offer their services to state residents.
Navigenics and DNATraits both received letters last week telling them that they were in violation of California statutes, and both said they are unsure about how a requirement for doctor oversight will affect their business in the state. Both companies also claim that the state's laws are vague and unevenly applied, and that there are uncertainties about how these laws apply to their services.
The CDPH said it sees a clear infringement of the law.
“Any laboratory offering genetic tests to California residents must be licensed as a clinical laboratory in California and have a federal Clinical Laboratory Improvement Amendments (CLIA) certificate for laboratory testing,” CDPH spokeswoman Lea Brooks told GenomeWeb Daily News in an e-mail.
Brooks also said the doctor oversight rule is clear. “In California, all genetic tests must be ordered by a licensed physician.” 
California officials took action after they investigated a total of 25 firms “in response to numerous consumer complaints about the accuracy and cost of genetic testing advertised on the Internet,” Brooks added.
In its cease-and-desist letters, however, CDPH focused not on complaints regarding price or accuracy, but on the state's licensing and doctor oversight laws.
Bennett Greenspan, a founding partner at Texas-based DNATraits, which offers tests for genetic disorders and inherited traits and received a notification from the CPDH, described the move as a blunt maneuver.
“It might have been prudent for the state of California to make some phone calls” and get a better sense of what these businesses do before drafting their cease-and-desist letters, Greenspan said. “The way that I read that law in California, you shouldn’t be able to buy a thermometer, especially a rectal thermometer because it’s invasive.”
“We received no inquiry before receiving the notice,” Mari Baker, CEO of Navigenics, which also received one of the letters, told GWDN. Baker said that at the moment, her company “hopes that much of this stems from a lack of understanding.”
Greenspan said DNATraits has already complied with the California ruling by not allowing California residents to order its services, and he said the company will seek to satisfy compliance with the lab license rule for its lab in Houston.
But he finds the physician oversight law deeply flawed for this field, noting that DNATraits offers genetic counseling services for its customers at the time of order and when the results of the genotyping are returned.
“If you go ask a random 100 doctors to talk about genetic disease, a huge number of them will say that don’t know much about that. Genetic counselors … that’s what they do for a living,” he said.
“I don’t think it is in anyone’s best interest for the state to say you can’t test unless an MD says it’s okay,” Greenspan continued. “It’s your DNA. You’ve got the right to know.”
Consumer genomics companies are scratching their heads about how California came up with the list of companies it found in violation. DNA Direct offers a similar service as many of the other firms, but did not receive a letter, and on its website pointed to that as a badge of merit.
On its website, DNA Direct said its lab is CLIA certified, which is not the same as having a California license, and that the test includes “authorization by an MD medical geneticist.”
California Pushing for Feds to Take the Lead
CDPH began scrutinizing these companies recently as part of a larger investigation of how many medical testing labs in the state are licensed and accredited, CDPH Director of Laboratory Field Services Karen Nickel told a group of health regulators and interested parties in a June 13 conference call.
“This [investigation] is part of a larger push to get labs that are not accredited in California into compliance with the law,” Nickel told the group.
But some wonder why genetic tests offered directly to consumers received special emphasis in the investigation. The whole enforcement issue by the state against these firms appears to some to be an attempt to impose clarity and order to a field that has far outpaced the law.
Direct-to-consumer testing and state law “puts us between a rock and a hard place,” Nickel told the group, and listed a number of problems these tests present. “There’s a lot going on right now, but we’ve started it this week by no longer tolerating direct-to-consumer genetic testing in California,” Nickel said.
“And what changes are we looking for? We’re looking for some kind of federal action,” she explained, suggesting that the big goal of the round-up is to get the US Food and Drug Administration to clarify regulations so that the states do not have to deal with companies that offer services over the internet around the world.
The FDA did not return calls seeking comment by press time.
Nickel described a state regulatory body that is unprepared, in terms of available laws and policies regarding DTC testing, to perform its functions as a protector of health. “The public demands access, but their concern about the cost and the accuracy has created the ‘worried well,’” she said.
“They want to [take genetic tests] but they’re afraid to do it. And once they get the results, they don’t know what to do about it,” she said. “That’s the state perspective.”
Peter Kazon, a lawyer with Allston & Bird who has specialized in medical diagnostics regulatory affairs, thinks that beyond licensing and doctor oversight concerns, a background issue that could become important is the larger question of exactly what these companies are selling. If a company's service informs a customer that they have a genetic variant that puts them in a broad risk category for cancer or Alzheimer’s, the product is that information, he said.
One aspect of the California action, Kazon added, is that the regulators want to know what the science is behind these services’ claims and how those claims are communicated to patients.
“California is saying this is healthcare information, and not just saying, ‘Am I related to Barack Obama in my distant past?’ You’re telling people healthcare information,” he said. 
The potentially complicated issue Kazon sees springs from a section of the state law that was adopted from a US Code of Federal Regulation stating that these kinds of tests must have established performance specifications for a number of factors including accuracy, precision, analytical sensitivity, analytical specificity, and others.
How state or federal regulators should gauge the performance or accuracy for a test that does not make a claim about disease, but about the presence of a genetic marker for a predisposition, could be become a highly complicated issue if it is left to be handled on a state-by-state basis.
Nickel said there is a “need to clarify diagnostic versus predictive reports.”
Because of the difficulty of interpreting the meaning and utility of the information being provided to consumers, direct-to-consumer testing has been subject to criticism about whether these services are ready for public consumption.
For example, Muin Khoury, head of the National Office of Public Health Genomics at the US Centers for Disease Control and Prevention, recently joined with two academics to criticize some of the new services in the New England Journal of Medicine as too immature to be of use to the public.
Such criticism and the moves by California and New York to begin to control the industry could set the stage for a federal dialogue about regulation in this quickly evolving field.
“I’d rather there be a federal solution than a state solution,” DNATraits’ Greenspan told GWDN, “just as a matter of efficiency.
“It doesn’t matter to me, as long as everybody on the regulation side has a common mind as to what is reasonable. You just want to make sure you have standard, consistent procedures,” he added.
“The way they write the law,” Greenspan said, “it sounds like they really don’t want genetic testing. If they only want it to go through two companies, then of course the price is going to be sky high forever.”

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