It's difficult to know what, exactly, to make of California SB 482. On the one hand, it seems doomed to fail, so why discuss it? On the other hand, it casts an interesting light on a very hot discussion.
In a nutshell, the bill seeks to create a new (much less stringent) regulatory category for "post-CLIA bioinformatic services" (known to the rest of us as DTC genomics tests). According to the Merc, the bill is the handiwork of 23andMe.
On one hand, you have to appreciate the chutzpah. If you don't like the rules governing medical testing, why not write new ones? Given our strong belief in the transformative effect of new technology, there's a distinct flavor of Bay Area optimism to this regulatory strategy.
On the other hand, it's not difficult to smell the desperation. It's a virtual admission that genomic risk-score tests won't pass muster under the current standards. As such, it's a legal Hail Mary pass... the kind of play you attempt when you've already lost anyway.
Even if this play miraculously works, it strongly suggests the business model may be circling the drain. SB 482 suggests that DTC genomics requires a regulatory environment where low-quality results are subjected to a far lower level of oversight than high-quality results. Will such a system ever come to pass?
FDA hasn't shown any desire to create that system. Established players who have already proven the value of their tests won't stand for it. Consumers aren't agitating for it. Medical groups such as CAP are opposed to it. The major constituency for lower standards, it seems, are the companies who need them. That's going to be a tough hill to climb.
On principle, you should never underestimate any state's ability to adopt ill-conceived legislation. Stupider things have become the law in California and for all I know, this might just work.
Even if it does, you have to wonder if it will do much more than delay the inevitable.
Tags: Enforcement, IVD, LDTs
