Friday, March 20, 2009

Navigenics has a lab.....NYS will likely regulate this too!

Navigenics now is the proud owner of a laboratory. Congratulations! Now New York State has some hefty regulations for you. Otherwise, you can't test people in New York.....Pay close attention to numbers 4 and 5....

NYS Clinical Laboratory Permit Requirements
1. Qualified Director, PhD, 4 yrs post doc work.
2. Application and fee 1100 USD
3. Inspection
4. Assay validation
5. Compliance with all applicable statutes and rules

Assay Validation?????

1. Assay description
Suitable to guide authorized person in ordering the test

2. Consent process
Consistent with NYS CRL s 79-l

3. Analytical validity
Ability to detect and/or measure analytical target

4. Clinical validity
Documented association of analytical target with clinical condition or outcome

5. Reporting format
Interpretation suitable for non-geneticist

Clinical Validity????? Uh-Oh.....

Compliance with all applicable statutes and rules

NYS PHL Article 5, Title 510 NYCRR 58

1. Laboratories may perform tests only at the request of a "person authorized by law" to make use of the test results (physician)
2. Laboratories must report the results of the test only to the person who ordered the test
3. Laboratories may communicate with the tested person only at the written authorization of the ordering person, and then only to repeat the test results

So Much For Direct To Consumers.

Direct billing law

1. Laboratories must bill the person tested (or their insurance with authorization)
2. Provider to provider exception as between laboratories
"Facilitators" cannot receive funds from the person tested or pay laboratory service bills on behalf of that person

So much for Genome Broker websites.......


There can be NO fiscal or other incentives provided by the laboratory or other entity to the ordering practitioner

1. Payment of any fee
2. Employment
3. Provision of services to the tested person that would otherwise be provided by the practitioner

So Much for that extremely smart and very nice Genome DTC Business Development Lady in Redwood City who offered me tests at Wholesale for Resale at mark up......

The Sherpa Says: A lab is no quick fix for a bad business model or a company that is trying to peddle something as clinical which has NO PROVEN CLINICAL VALIDITY.......Clinical is probably not the way to go for these companies. I think Novelty test is the right way.....AND NOT clinical, until it IS CLINICAL......Too Early, Too Untested....and making everyone suspect of fields which ARE REAL like PGX....

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