Steve, do you counsel labs that have that decision to make?
Steve Swartzell: Yes, depending on the test type, whether an IVD, ASR, or RUO. We provide full assistance with an IVD test. ASRs and RUOs are trickier because of the regulatory environment for those tests; for those we provide consulting and troubleshooting support. For ASRs it’s up to the lab to develop the test and validate it on its system.
Despite the recent decision on LDTs, concerns remain—there is still a chance for regulation. Do people ask you about that?
Scott Johnston: They do. There is still uncertainty and trepidation about what the government is going to do. You can go with what is published, which is what we’re doing now.
The following four questions are from listeners of the roundtable.
Can your tests run on open channels or on platforms other than those from ELITech?
Steve Swartzell: Yes. We have several customers who are running tests on different platforms. Most of our dyes are designed to go on the open platforms present in most labs. If a customer has a question about a specific instrument, we can talk to them about what that would entail.
The beauty of lab-developed tests is that labs can develop them on whatever platform they have.
LDT assays have created confusion from a regulatory perspective. Can you explain the CLIA requirements for LDT assays? Can the LDTs developed by a national reference lab be offered nationwide, or are they restricted to the health care facility that performs the validation?
Scott Johnston: Individual reference labs do their own LDT development and validation, and those tests go through groups like the Wadsworth Center [New York State Department of Health] for verification and approval. Those tests are specific to that institution.
As for the CLIA requirements, you must be able to demonstrate within your laboratory in a subpopulation of those patients the assay’s performance with the specific configuration being used and that it is updated to show it is working as expected. That’s submitted to an accrediting body for approval. You must comply with the quality management regulation in your laboratory so you can demonstrate you met the necessary study parameters to prove the LDT works and you’re maintaining the data over time. If something has changed, you can show you’re taking care of this assay accordingly.
Given the current ambiguity around LDT regulation and the rapid pace of AI and automation and diagnostics development, how is ELITech prioritizing its investments to balance immediate operational efficiency and regulatory compliance with the long-term need for scalable, future-proof data integration and innovation?
Scott Johnston: “Investments” and “balance” are the key words. There is only so much money, time, and labor, so the question is how to balance those and meet the market need. We look strongly at existing disease states that are of interest to a variety of groups. In the past few years we’ve seen a lot of steel on the floor, meaning many labs have purchased a lot of high-throughput equipment, and when the need decreased after the pandemic, they’re left with testing capability or volume that’s not being taken up.
We want to look into disease states that have enough volume to justify a lab’s investment in an LDT, because it’s not inexpensive and it requires a lot of labor. We’re looking at investing in new assays such as for measles, which is top of mind these days. Is that a lot of samples? No. But it is growing. HHV-7 and other herpes viruses have enough volume and interest from the laboratory that it’s worth the development. We listen closely to what labs are telling us.