Congratulations...Sort Of....

For those of you who had no internet/tv/WSJ access this week (But how could that be if you are reading this post?) Navigenics, the DTC genomic testing company has officially launched. 11/6/07 (Funny, my lucky number just happens to be 24) What they offer is pretty decent

From the WSJ

"The company believes people will want to take the $2,500 test when they're healthy, and then make lifestyle and other changes to avoid or delay disease. Results, which will be posted on a Web site that customers access with a password, will tell consumers their risk for more than 20 conditions, including diabetes, obesity, prostate cancer and glaucoma"

Not a bad price for 20 genetic tests. Who gives the counseling? Navigenics can. Will this replace high priced tests like BRACAnalysis? Maybe. But here is DTC testing's Achilles heel.

New York State has laws on medical privacy, genetic privacy, and human subject protection, making it among the more restrictive states for the conduct of research or genetic testing.

New York prohibits the conduct of “genetic tests” without the prior written informed consent of the individual. A genetic test is defined as:

“…. Any laboratory test of human DNA, chromosomes, genes, or gene products to diagnose the presence of a genetic variation linked to a predisposition to a genetic disease or disability in the individual or the individual’s offspring; such term shall also include DNA profile analysis. ‘Genetic test’ shall not be deemed to include any test of blood or other medically prescribed test in routine use that has been or may be hereafter found to be associated with a genetic variation, unless conducted purposely to identify such genetic variation.”

According to the statute, prior to a genetic test, individuals must be notified, individual authorization must be obtained, and specific elements must be incorporated into the informed consent form including: a general description of each specific disease or condition tested for, the level of certainty that a positive test result for that disease or condition serves as a predictor of such disease, the name of the person or categories of persons or organizations to whom the test results may be disclosed, and a statement that no tests other than those authorized shall be performed on the biological sample.

Bottom Line- A separate consent for each disease which is tested for!

For clinical genetic tests, the informed consent must state that the sample shall be destroyed at the end of the testing process, or not more than sixty days after the sample was taken, unless a longer period of retention is expressly authorized. New York law requires individual authorization for sample retention for up to ten years if no genetic testing is performed; however, informed consent must be obtained prior to the conduct of genetic tests. Retention of a DNA sample past a period of ten years requires explicit consent for a longer or indefinite period of retention.

Bottom Line-A separate consent for DNA Banking

So what does the written consent look like? I wonder what dream team of lawyers have debated these issues. This is not the first time laws to protect the patient were devised. Back in 1997 we had some similar arguments.

In addition to the thoughts of individual consents for zillions of "possible" tests. Who constructs consents for tests never conceived? I imagine you will have to review the DTC testing legislation in each state. A nice review is here at Hopkins.

In my states (CT, NY) we have many prohibitive laws....

From CT

Regs.Conn. State Agencies §19a-36- D29(a)

Regs., Conn. State Agencies §19a-36-D32(a)

Laboratories may accept specimens only upon request of licensed physician or other persons
authorized by law to make diagnoses. Laboratories may report findings only to the licensed provider that ordered the test. Laboratories may provide results to lay persons upon written request of the provider who ordered the test. An official at the Connecticut
CLIA Laboratory Program confirmed that DTC testing is not permitted.

New York?
N.Y. Pub Health Law § 576-b N.Y. Pub. Health Law § 577 10 NYCRR § 19.1(j) 10 NYCRR § 58-1.7 10 NYCRR § 58-1.8 10 NYCRR § 63.3(e)

In general, tests may be ordered only by licensed physicians “or other persons
authorized by law to use the findings of laboratory examinations in their practice or the
performance of their official duties.” Consumers are not listed among those
authorized. Test results cannot be sent directly to patients except with written consent of the
physician or authorized person, except blood type and RH factor can be given in writing to
the patient without written consent. DTC testing is permitted for tests that have been
approved by the Food and Drug Administration for direct, over-the-counter sale

to consumers. An official with the New York State Department of Health confirmed that
DTC testing is not permitted, other than for certain tests relating to the blood supply, such as HIV and Hepatitis C tests.

The Sherpa Says:

Congratulations Navigenics....I look forward to the hordes of lawyers, genetic counselors, and States' Attorney Generals. More importantly, this should serve as a wake up call to all DTC testing companies playing around in CT and NY. Consider yourselves warned! DTC testing in these states is Illegal! Luckily at Helix Health of Connecticut there are trained physicians and counselors skilled at guiding you through the testing process. In the offices in Greenwich or New York, Or through our home visit service. You get the best of both worlds, testing AND counseling!