I think I have argued this logic several times but perhaps have not sharpened it to the level this need to be.
DTC Genomic/Genetic testing is not medicine. That is the claim.
The answer as to why not?
"It is not intended to diagnose or treat any condition."
Yes, that is the infamous vitamin line.........
Does it work with DTC Genomics? No.
Why? We need to deconstruct the word "intended"
What is Intent? Legally, I mean. It has a few definitions.
"The determination or resolve to do a certain thing, or the state of mind with which something is done."
Make you wonder what state of mind means.....
Another definition and explanation of intent
Intent is a mental attitude with which an individual acts, and therefore it cannot ordinarily be directly proved but must be inferred from surrounding facts and circumstances. Intent refers only to the state of mind with which the act is done or omitted.
So this has all the hallmarks of building a case for intent.
Just because you say you "don't intend" doesn't mean you do not.
You have to examine the facts here to see the mental attitude of those who are doing the act.
In this case The Sherpa Vs. 23andSergey Sherpa alleges that 23andSergey's intent is to "diagnose or treat"
His facts are:
23andSergey tests human biologic samples for BRCA mutations.
Mutations in BRCA create a medical condition known as "Genetic Susceptibility to Malignancy of the Breast"
It is coded in the International Classification of Disease under the V84.01
23andSergey reports acknowledge this and report this result to their customers.
The specific language of what they test is as follows
Breast/Ovarian Cancer is one of the conditions that 23andMe analyzes. Our service includes the following information:
- Whether or not you are a carrier for several mutations linked to breast/ovarian cancer risk.
- Information on 185delAG, 5382insC and 6174delT, three of the most common among hundreds of mutations in the BRCA1 and BRCA2 genes that influence risk for Breast/Ovarian Cancer.
- Background information on Breast/Ovarian Cancer and a list of counselors, links and support groups in your area.
"The genotyping services of 23andMe are performed in LabCorp's CLIA-registered laboratory. The results presented in Health and Traits have not been cleared or approved by the FDA but have been analytically validated according to CLIA standards."
CLIA is an acronym for: Clinical Laboratory Improvement Amendments.
These amendments apply to Clinical Laboratories ONLY.
Why would a company need CLIA to test samples if the INTENT was not to perform a clinical test.
What is a clinical laboratory? From the CLIA site: "
A laboratory is defined to be a facility that performs certain testing on human specimens in order to obtain information that can be used for the diagnosis, prevention, or treatment of any disease or impairment of a human being; or the assessment of the health of a human being; or procedures to determine, measure or otherwise describe the presence or absence of various substances or organisms in a human body (42 C.F.R. sec. 493.2.)."
And from that a clinical test is:
used to obtain information that can be used for the diagnosis, prevention, or treatment of any disease or impairment of a human being; or the assessment of the health of a human being; or procedures to determine, measure or otherwise describe the presence or absence of various substances or organisms in a human body (42 C.F.R. sec. 493.2.)."
Why would a company submit test with a CLIA facility if its INTENT was not to test clinically?
Does it make any logical sense that a company would chose to use a CLIA lab otherwise?
Maybe... But not likely. You see, CLIA does affect direct to consumer tests, just like it does physician ordered tests.
BUT, It does not affect tests which are not for clinical use. Why agree to clinical regulations, if you are indeed not providing Clinical tests?
This point demonstrates some of the "mindset" of 23andSergey. Do they defendants realize that what they are testing for has clinical consequences?
I would say so from their special insert box on the BRCA page, which reads
"This report has information that may indicate substantial odds of developing the disease. Because of the potential impact of this report, we require that you opt-in before viewing your results. It is possible to use the rest of the 23andMe service without viewing your results for this disease. In addition, no one else can see your data for this disease, including those with whom you have basic and extended sharing."
But what they don't realize is that this carrier state is classified as a medical diagnosis/condition.
V84.01-Genetic Susceptibility to Malignancy of the Breast
What is their "state of mind" about what they are doing. Do they intend to give risks about diseases?
They list prominently on their site the "conditions" they test to determine, measure or otherwise describe the presence or absence of various substances or organisms in a human body The substance in this case is DNA code.
DNA code to give risk to health by disease risk What diseases? The defendants cleverly call these "conditions" On their site they list some.
Our Traits & ConditionsAside from eye color, each one of these "Conditions" has an International Classification of Disease code number.
I argue that this company's and others like it have the INTENT to
1. Obtain human specimens for the purpose of quantifying and qualifying a substance in the human body "DNA"
2. Give assessment about the health of that individual by ascertaining their risk of disease through analysis of the DNA.
3. Portray that they are testing for "Diseases" as evidence by the "conditions" they test for.
In fact, upon further construction of this case it is crystal clear that 23andme is intended to diagnose, because its intent is to perform a clinical test and give information regarding that result to the customer/patient.
Because of this I recommend that this dtc company license with the medical board of each state in which it provides clinical testing.
Just saying it isn't "intended" does not make it so when the "intent and mind set" portrayed through its website is contrary to what is stated in "fine print"
The Sherpa Says: Playing doctor on TV is never dangerous, but playing it in real life while you deny you are is very, very dangerous.