Tuesday, November 10, 2015

New Flurry of Letters to LDT Labs: FDA Found You!

November opens with the FDA sending letters to at least three LDT labs, DNA4Life, DNA CardioCheck, and Interleukin Genetics, in Alabama, Illinois, and Massachusetts, respectively.

The three letters are online at the FDA here, here, and here.  For November 16 coverage at Bloomberg, see here.

The FDA notes that the tests are both LDT tests and offered in a DTC model.  While I haven't checked each state for its legal system for direct access testing, these FDA activities suggest at least the possibility of a conflict between state law (where a state might pass a liberal consumer access law for DTC lab tests, like Arizona's) and federal law (where FDA does *not* like labs to offer DTC lab tests, especially if they are LDT tests.)

Theranos would be a tough case, since its large tests panels seem to be a mix of (A) one locally invented FDA cleared lab test (for blood herpes), (B) a variably offered panel of LDTs on the locally invented Edison device aka LDTs, and (C) conventionally manufactured test kits and platforms.  Selectively among these options, FDA would seem to be most concerned if and when an LDT test is also a DTC test, even where state law allows or encourages DTC tests.   (Think federal law contra marijuana despite a state law allowing sale and use of it.)

I have not seen this mentioned in the wide spectrum of Theranos press, but Theranos' one FDA cleared special test, for herpes in blood, seems like a hard test for a solo untrained consumer to evaluate.  Lay people with their DTC result would face questions like: what a positive result means, what a negative result means, whether it is for Type I, Type II, or both; how a negative test should be interpreted in light of an incubation period; whether it is an viral antibody or a viral DNA test as they read about either on the internet; and so on.