Is the recent FDA proposal a blessing, curse, or both for our patients and practice? Dr Paul Auwaerter comments.
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Johns Hopkins offers a number of LDTs. I rely on them in diagnosing adenovirus infections, especially in immunosuppressed patients with pneumonia or liver issues with fever. Our lab has validated an LDT for, finding that it offers better sensitivity than available commercial multiplex kits. Our lab is very careful about releasing LDT results until it has demonstrated sufficient analytic sensitivity with clinical samples.
What does this mean for clinicians? Our clinical microbiology department is preparing because if this rule moves ahead, they will have to seek premarket approval for their LDTs. This may require a lot of paperwork and cost, and the FDA could be inundated with LDTs. But as long as the lab has called premarket approval, it could still be offered as long as it remains within one lab. Someone in our laboratory pointed out that the range of LDTs is fairly broad.
In areas where patients and physicians are using LDTs that provide false information or lead to invalid diagnoses, the new LDT rule would be beneficial. It will be interesting to see how this rolls out over the next few months or so. If it comes to be, it will no doubt change your practice, hopefully for the better.
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