James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in 360Dx, in “NY State Database Offers Glimpse into Laboratory-Developed Testing Landscape,” by Adam Bonislawski. (Read the full version – subscription required.)
Following is an excerpt:
The laboratory-developed testing space in New York state is dominated by large national labs with areas like oncology, genetics, immunology, and infectious disease testing as major areas of focus, according to an analysis by 360Dx. …
James Boiani, an IVD, drug, and medical device life sciences attorney at Epstein, Becker & Green in Washington, D.C, said that the low number of LDTs from out-of-state academic medical centers in the New York state database is “really interesting” and “aligns with the fact that with academic medical centers in lots of cases, patients are going to them and collection and testing is performed where the medical center is.”
Whether this has implications for how LDTs from such centers should be regulated, is a different question, though, Boiani said.
He said he expects that any carve-outs in LDT regulation will be based not on the commercial reach or strategy of the performing facility but on factors like the number of patients a test is meant to serve and whether a particular testing need can be met by IVDs. The VALID Act offered some such provisions, exempting tests for noncontagious disease or conditions that affect no more than 10,000 individuals in the US annually and tests “developed to diagnose a unique pathology or physical condition of a specific patient or patients,” provided the test isn’t intended for use in more than five patients and isn’t included on the performing lab’s test menu or in its marketing materials. …
Boiani also noted that there is a likely some percentage of labs that are pursuing a national commercialization strategy but have not yet taken their LDTs through the New York state process.
