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Tag: California Department of Health

Two DNA Testing Companies Set to Resume Business in the Bay Area

Written by on Wednesday, August 20th, 2008

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.

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DNA Testing Companies Pulling Out of California Direct-to-Consumer Market

Written by on Tuesday, June 24th, 2008

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.

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Fallout Over Genetic Testing Controversy Continues

Written by on Wednesday, June 18th, 2008

The fallout over California’s attempts to regulate genetic testing continued today as more facts over the California action came to light.

As the California Biotech Law Blog reported earlier this week , California’s Department of Health sent out cease and desist letters to thirteen genetic testing companies, including Navigenics, Inc. and 23andMe, Inc, demanding that these companies halt sales in the state until they can demonstrate that their laboratories are certified by the state and federal governments and that the tests have been ordered by a doctor as required by state law.

Wired.com is following the controversy, and has obtained copies of the letters that went out to at least two of the recipients.  Alleging that the companies violated California law, the letters cite eight statutory provisions of California’s Business and Professions Code in support of their allegations: Sections 1206(a)(4), 1220(d), 1241, 1246.5, 1265(a)(1), 1281, 1287(b)(3), 1288. 

These provisions state as follows:

    • 1206(a)(4):"Clinical laboratory test or examination" means the detection,
      identification, measurement, evaluation, correlation, monitoring,
      and reporting of any particular analyte, entity, or substance within
      a biological specimen for the purpose of obtaining scientific data
      which may be used as an aid to ascertain the presence, progress, and
      source of a disease or physiological condition in a human being, or
      used as an aid in the prevention, prognosis, monitoring, or treatment
      of a physiological or pathological condition in a human being, or
      for the performance of nondiagnostic tests for assessing the health
      of an individual.

 

    • 1220(d) (1) Each clinical laboratory shall perform all clinical
      laboratory tests or examinations classified as waived under CLIA in
      conformity with the manufacturer’s instructions.
         (2) Except for those clinical laboratories performing only tests
      or examinations classified as waived under CLIA, each clinical
      laboratory shall establish and maintain all of the following:
         (A) A patient test management system that meets the standards of
      CLIA in Subpart J (commencing with Section 493.1101) of Title 42 of
      the Code of Federal Regulations.
         (B) A quality control program that meets the requirements of CLIA
      in Subpart K (commencing with Section 493.1201) of Title 42 of the
      Code of Federal Regulations.
         (C) A comprehensive quality assurance program that meets the
      standards of CLIA in Subpart P (commencing with Section 493.1701) of
      Title 42 of the Code of Federal Regulations.

 

    • 1241: This chapter applies to all clinical laboratories in
      California or receiving biological specimens originating in
      California for the purpose of performing a clinical laboratory test
      or examination, and to all persons performing clinical laboratory
      tests or examinations or engaging in clinical laboratory practice in
      California or on biological specimens originating in California,
      except as provided in subdivision (b).
         (b) This chapter shall not apply to any of the following clinical
      laboratories, or to persons performing clinical laboratory tests or
      examinations in any of the following clinical laboratories:
         (1) Those owned and operated by the United States of America, or
      any department, agency, or official thereof acting in his or her
      official capacity to the extent that the Secretary of the federal
      Department of Health and Human Services has modified the application
      of CLIA requirements to those laboratories.
         (2) Public health laboratories, as defined in Section 1206.
         (3) Those that perform clinical laboratory tests or examinations
      for forensic purposes only.
         (4) Those that perform clinical laboratory tests or examinations
      for research and teaching purposes only and do not report or use
      patient-specific results for the diagnosis, prevention, or treatment
      of any disease or impairment of, or for the assessment of the health
      of, an individual.
         (5) Those that perform clinical laboratory tests or examinations
      certified by the National Institutes on Drug Abuse only for those
      certified tests or examinations.  However, all other clinical
      laboratory tests or examinations conducted by the laboratory are
      subject to this chapter.
         (6) Those that register with the State Department of Health
      Services pursuant to subdivision (c) to perform blood glucose testing
      for the purposes of monitoring a minor child diagnosed with diabetes
        if the person performing the test has been entrusted with the care
      and control of the child by the child’s parent or legal guardian and
      provided that all of the following occur:
         (A) The blood glucose monitoring test is performed with a blood
      glucose monitoring instrument that has been approved by the federal
      Food and Drug Administration for sale over the counter to the public
      without a prescription.
         (B) The person has been provided written instructions by the child’
      s health care provider or an agent of the child’s health care
      provider in accordance with the manufacturer’s instructions on the
      proper use of the monitoring instrument and the handling of any
      lancets, test strips, cotton balls, or other items used during the
      process of conducting a blood glucose test.
         (C) The person, receiving written authorization from the minor’s
      parent or legal guardian, complies with written instructions from the
      child’s health care provider, or an agent of the child’s health care
      provider, regarding the performance of the test and the operation of
      the blood glucose monitoring instrument, including how to determine
      if the results are within the normal or therapeutic range for the
      child, and any restriction on activities or diet that may be
      necessary.
         (D) The person complies with specific written instructions from
      the child’s health care provider or an agent of the child’s health
      care provider regarding the identification of symptoms of
      hypoglycemia or hyperglycemia, and actions to be taken when results
      are not within the normal or therapeutic range for the child.  The
      instructions shall also contain the telephone number of the child’s
      health care provider and the telephone number of the child’s parent
      or legal guardian.
         (E) The person records the results of the blood glucose tests and
      provides them to the child’s parent or legal guardian on a daily
      basis.
         (F) The person complies with universal precautions when performing
      the testing and posts a list of the universal precautions in a
      prominent place within the proximity where the test is conducted.
         (7) Those individuals who perform clinical laboratory tests or
      examinations, approved by the federal Food and Drug Administration
      for  sale to the public without a prescription in the form of an
      over-the-counter test kit, on their own bodies or on their minor
      children or legal wards.
         (8) Those certified emergency medical technicians and licensed
      paramedics providing basic life support services or advanced life
      support services as defined in Section 1797.52 of the Health and
      Safety Code who perform only blood glucose tests that are classified
      as waived clinical laboratory tests under CLIA, if the provider of
      those services obtains a valid certificate of waiver and complies
      with all other requirements for the performance of waived clinical
      laboratory tests under applicable federal regulations.
         (c) Any place where blood glucose testing is performed pursuant to
      paragraph (6) of subdivision (b) shall register by notifying the
      State Department of Health Services in writing no later than 30 days
      after testing has commenced.  Registrants pursuant to this
      subdivision shall not be required to pay any registration or renewal
      fees nor shall they be subject to routine inspection by the State
      Department of Health Services.

 

    • 1246.5: Notwithstanding any other provision of law, any person may
      request, and any licensed clinical laboratory or public health
      laboratory may perform, the laboratory tests specified in this
      section.  A registered clinical laboratory may perform the laboratory
      tests specified in this section if the test is subject to a
      certificate of waiver under CLIA and the laboratory has registered
      with the department under paragraph (2) of subdivision (a) of Section
      1265. A program for nondiagnostic general health assessment that
      includes a laboratory test specified in this section shall comply
      with the provisions of Section 1244.  The results from any test may
      be provided directly to the person requesting the test if the test is
      on or for his or her own body.  These test results shall be provided
      in a manner that presents clear information and that identifies
      results indicating the need for referral to a physician and surgeon.

         The tests that may be conducted pursuant to this section are:
      pregnancy, glucose level, cholesterol, occult blood, and any other
      test for which there is a test for a particular analyte approved by
      the federal Food and Drug Administration for sale to the public
      without a prescription in the form of an over-the-counter test kit.
      A test approved only as an over-the-counter collection device may not
      be conducted pursuant to this section.

 

    • 1265(a)(1):A clinical laboratory performing clinical laboratory
      tests or examinations classified as of moderate or of high complexity
      under CLIA shall obtain a clinical laboratory license pursuant to
      this chapter.  The department shall issue a clinical laboratory
      license to any person who has applied for the license on forms
      provided by the department and who is found to be in compliance with
      this chapter and the regulations pertaining thereto.  No clinical
      laboratory license shall be issued by the department unless the
      clinical laboratory and its personnel meet the CLIA requirements for
      laboratories performing tests or examinations classified as of
      moderate or high complexity, or both.

 

    • 1281:It is unlawful for any person to own, operate, maintain,
      direct, or engage in the business of operating a clinical laboratory,
      as defined in this chapter, unless he or she possesses a valid
      clinical laboratory license issued by the department.  In the event a
      health facility does not perform clinical laboratory services, but
      provides laboratory services to its patients under an agreement with
      another person or entity that holds and is operating under a valid
      clinical laboratory license, the health facility shall not be
      required to obtain a clinical laboratory license.

 

 

    • 1287(b)(3):  The enforcement remedies provided under this section are not
      exclusive, and shall not preclude the use of any other criminal or
      civil remedy.  However, an act or omission punishable in different
      ways by this section and any other provision of law shall not be
      punished under more than one provision.  Under those circumstances,
      the penalty to be imposed shall be determined as set forth in Section
      654 of the Penal Code.

 

    • 1288:Any person conducting or operating a clinical laboratory may
      accept assignments for tests only from and make reports only to
      persons licensed under the provisions of law relating to the healing
      arts or their representatives.  This section does not prohibit the
      acceptance of evaluation specimens for proficiency testing or
      referral of specimens or such assignment from one clinical laboratory
      to another clinical laboratory, either licensed or exempt under this
      chapter, providing the report indicates clearly the laboratory
      performing the test.  A report of results issuing from a clinical
      laboratory shall show clearly the name and address of the laboratory
      and the name of the director.

 

The letters demand that the party submit a plan before June 23, 2008 advising how the company will prevent further violation of the law.

It is impossible to determine from these letters whether or not these companies actually are in violation of the law;  however, assuming the allegations are in fact accurate, is this really the whole story?  Or is something else actually responsible for this "attack" on genetic testing companies?  What is prompting this interest in genetic testing?

I cannot help but wonder if the medical community is at the heart of this controversy.  But if this is in fact the case, what is the issue?  Is there a concern by doctors that they are going to be found guilty of malpractice simply as a result of something they either overlook or do not know how to respond to in the genetic testing report?  As we suggested in our previous blog posting, there is certainly some debate as to how accurate various genetic tests actually are and what, if anything, should be done in response to certain results.  On the other hand, is there a fear by the medical community that the public will not know how to handle the data in the report?  Or is there at the heart of this issue an entirely different matter entirely?

It is interestng that in the same week that this controversy has erupted, Newsweek ran a story about Dean Ornish’s new book, where he looks at how changing lifestyle can change genes.  The prospect of potentially changing your genetic predisposition by making lifestyle changes is perhaps the best argument for why the public should have direct access to these tests.  Thomas Goetz of Wired.com also makes a compelling argument for direct access, arguing that "Frankly, it’s insulting and a curtailment of my rights to put a gatekeeper between me and my DNA." 

To date, this controversy has erupted in only two states: New York and California.  There are forty-eight other states yet to take this issue up.  Those states will be looking to New York and California to see how they deal with the controversy.  Perhaps the California legislature should jump to the forefront of this issue and look at changing the law to ensure direct public access to genetic testing.  Such an action would undoubtedly set an important precedent for the other forty-nine states, which might very well follow in California’s footsteps.  California: will you rise to the challenge? 

The California Biotech Law Blog will continue following this controversy as it further unfolds.

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California Takes First Step Towards Regulating Genetic Testing Companies

Written by on Monday, June 16th, 2008

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.

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