Following up on our previous postings regarding California’s issuance of cease and desist letters to thirteen (13) genetic testing companies doing business in California, two DNA testing companies are now set to resume business in California, after having received new licenses to do business in the state.

According to The Mercury News, the California Department of Health has issued licenses to Navigenics of Redwood City and 23andMe of Mountain View, which will enable them to resume business operations.  Both companies had always argued that they were lawfully doing business in the state, and the fact that the state issued them both licenses seems to be a validation of their positions.

International Herald Tribune reported on the development as follows:

The companies had argued that they were not offering medical testing but rather personal genetic information services, and that consumers had a right to information from their own DNA. The companies also said they did not need a license because the actual testing of the DNA samples was being done by outside laboratories that did have licenses.

But the two companies do their own interpretation of the raw genetic data. Now, after reviewing the procedures used by the companies, the state is satisfied that the companies’ interpretation is based on the scientific literature. . . . the companies also satisfied the requirement for a doctor to be involved.

Navigenics already was paying a physician to review customer orders and now it appears that 23andMe might be doing something similar.

There is no word yet as to whether or not the other eleven (11) genetic testing companies, which also received cease and desist letters, will likewise receive licenses to resume operations in the state of California.  Today’s move should at the very least be viewed as encouraging by the similarly affected companies.  The action should also help to calm fears as to the state’s ulterior motives in attempting to regulate genetic testing companies.

Having said this, direct-to-consumer genetic testing has been virtually non-existent in the state of California for the past two months, and it is very likely that all of the genetic testing  companies have suffered at least some financial consequences as a result.  We have yet to see what the long-term impact of this incident will be on all of the affected businesses.

For now, however, concerned Californians can rest easy knowing that direct-to-consumer genetic testing will live to see another day in this state.

Wired.com is reporting that three DNA testing companies are pulling out of the California direct-to-consumer market, as a result of California’s recent action to send cease and desist letters to thirteen DNA genetics testing companies (See our recent  blog posting).

Alexis Madrigal for Wired.com reported yesterday that HairDx decided “on advice of legal counsel, to require California (and New York) residents to order their tests through a doctor.”  Then today, Madrigal reported that two additional genetics companies, Sciona and SeqWright, have decided to pull out of the California market.  According to Madrigal, SeqWright “ceased allowing tests from the state without even getting rapped by regulators.”

Will other DNA testing companies soon follow suit? It seems that the State of California’s actions may very well prove to have had a chiling effect over the whole DNA direct-to-consumer industry.  As Madrigal in his Wired.com column suggests, this may have very well been the intended result.

At least one company, however, may be prepared to take this fight to the next level.  Madrigal reported today that 23andMe seems to be standing its ground.  The company appears to be taking the position that it is in compliance with California law and is going to continue to sell in California at this time.  There is no word yet as to whether any other DNA testing companies are prepared to stand up to the state and challenge its regulatory actions.

It’s hard to see how these developments are good for the State of California.  One would have expected that a state as proactive as California with respect to promoting biotechnology and stem cell research would not have taken such a hard stance against direct-to-consumer DNA testing.  Will this incident ultimately prove to be the nail in the coffin for DNA testing services?  Certainly, California’s actions have the potential to initiate a wave of similar actions across the country, as other states may feel pressured to follow California’s lead.

The California Biotech Law Blog will continue to follow developments on this issue as they arise.

California’s Department of Health has taken a first step towards regulating genetic testing companies by sending out cease and desist letters demanding that they halt sales in state until they comply with quality and reliabilty standards, reported SF Gate. 

According to SF Gate, thirteen companies received the letters, including the two most visible genetic testing companies, Navigenics INc. and 23andMe Inc.

SF Gate reported:

All the companies have two weeks to demonstrate to regulators that their laboratories are certified by the state and federal governments, said department [of health] spokeswoman Lea Brooks. They must also show that the tests currently being sold to California residents have been ordered by a doctor as required by state law. . . . Companies face fines of up to $3,000 a day if they don’t comply.

The California action follows a similar action taken by the New York Department of Health earlier this year, as we discussed in our May 14th blog posting.

Having just spoken last week at the Beyond Genome Conference in San Francisco, where we were discussing the ins and outs of the recent advances in genetic testing , I was a bit surprised to read that California–given our robust biotech industry–was following in New York’s footsteps on this issue.  Moreover, I was surprised to discover that there is a state law in California requiring that genetic tests be ordered by a physician.

While perhaps it makes some sense to require the laboratories of these companies to be certified by the state and federal governments (although I confess that I do not know what is involved in the certification process), does it really make sense to require that all genetic testing be initiated by a doctor’s order?  Is this really good public policy? 

As I indicated in my prior posting on this issue, I personally would be rather reluctant to pursue genetic testing even if I was interested in the results simply because I would not want the results to get into the hands of the insurance companies.  Requiring that no testing can be pursued without a doctor’s order makes it virtually impossible to run the tests without the insurance companies obtaining copies of the results.  According to Ryan Phelan, the CEO and Founder of DNA Direct, who also spoke at the Beyond Genome Conference last week, genetic test results are not even considered uniformly reliable across the board; some tests are viewed as being more reliable than others.  Would this be understood, however, by the insurance companies evaluating the results?  I personally would not be willing to take that risk.  Then again, as I have shared with blog readers previously, I have had first-hand experience with the challenges that can be encountered with obtaining health insurance even when young and in relatively good health, as my COBRA insurance was terminated six months after my previous employer closed its doors and I was forced to go out and look for insurance on the open market before I had "exhausted" my COBRA under state law.  Based on my experience, it is not inconceivable to think that an insurer would label you "uninsurable" solely on the basis of your genetic testing results. 

In evaluating the debate over genetic testing, I cannot help but  wonder what is at the crux of the fears over confidential genetic testing.   Is the medical community concerned that a public that already has access to HIV and pregnancy testing over-the-counter somehow cannot handle genetic testing results?  Is there a concern about protecting the public from reliability issues arising from some of the genetic tests?  Is there a worry about what the public will do with the information, or what the public will expect physicians to do with the information? Or is something else entirely at the heart of these concerns?

I’m interested to hear any commentary on the genetic testing debate: should there be laws in place to require physicians to be involved with genetic testing, or to order the tests?  Would you be deterred from pursuing testing because of a physician’s involvement?  Do the laws need to be changed so that states cannot in essence "shut down" genetic testing start-ups that are emerging in the marketplace? 

The California Biotech Law Blog will continue to follow this issue as it unfolds, and we will keep you posted on any feedback we receive on the issue.

A legal issue is brewing between companies conducting at-home DNA testing and some state governments, which object to the fact that these companies are conducting such tests without state permits and/or physician supervision, according to a report by Forbes.

Forbes reported on the issue as follows:

New York State’s Department of Health recently sent letters raising the specter of fines and jail time to 23andMe, its competitor Navigenics, their partners Illumina and Affymetrix, and five other gene-testing outfits. The state says they can’t do their scans without permits. (Navigenics says it uses a licensed doctor.) California is investigating 12 public complaints about certain mail-order gene testers.

In Maryland a health department official frets that self-prescribed gene tests have "serious potential for causing harm" if misinterpreted. Overall, 24 states prohibit or limit certain testing without a doctor’s involvement, according to the Johns Hopkins University’s Genetics & Public Policy Center.

Should the states have the ability to regulate gene testing, and should that regulation require the supervision by a licensed doctor?   This question raises some interesting public policy issues.

As a consumer, if I were to pursue gene testing, I am not sure that I would want such testing run through a physician, since in all likelihood, that would mean that the test results would end up in the hands of my insurance company, whereas, if I paid a company privately for such tests, the information is more likely to remain private.   My preference would be to have the tests privately run and then take responsibility myself for ensuring that the appropriate medical tests were run subsequently to screen for whatever illnesses that the testing had indicated I would be genetically inclined to catch.

In contrast, I am sure that a physician’s perspective would be that a physician needs access to the results in order to better treat the patient.  The physician might argue that the results are worthless unless the physician has access to the information.  He or she might even argue that it is not in the patient’s best interest to be told the results without having a physician there to interpret the data or to offer some support as needed.

I am interested in hearing what the blog readers have to say on this issue: should private companies be allowed to run gene screening tests privately without being regulated by the individual states and without requiring that the tests be run under a physician’s superivision? If you have any comments on this issue, please pass them along and we will post them to the site.

There is little doubt that this debate is going to continue to receive attention in the near future as gene testing increases in popularity.  We will keep you posted here at the California Biotech Law Blog as the debate further develops.