Clinical Laboratory Improvement Amendments

So I would say like this.

First of all, we are CLIA certified.

It means that basically CLIA is another regulatory body, parallel to the FDA, typically focuses on approving labs.

So they kind of came to the center stage during COVID.

If you remember, people talked about LDTs or laboratory developed tests.

And if your lab passes all the criteria, you can... develop a test in that lab, but only sell outside of that lab.

So this is something that kind of bridges the gap for many diagnostics company until they get their FDA approval.

So we are able to sell to the US population with the CLIA certification.

We want to thank Blythe and Dan for joining us on the podcast today.

One note for listeners, there's a whole other version of this in the lab, CLIA and lab developed tests, that we will be discussing in a future episode.

Different roles, same kind of gray zone.

Dan, any final thoughts that you'd like to add?

And so where are you guys up to in terms of the life cycle now of development, capital raised, and what sort of phase are you in as a company in bringing the test to life?

Yeah, so we have a CLIA laboratory in Research Triangle Park and we have launched tests.

So we have university partnerships with some of the researchers that have really invented and published on these new technologies.

We take that information, we validate it, we make it You know, we put in the quality controls and systems in place to do testing on a daily basis.

So our CLIA laboratory is regularly doing testing for providers.

And we're generally focused on the U.S. just because that's where we are.

And in shipping and logistics are a little bit easier, but we have done some international testing as well.

Our focus is on the clinical studies for our Lyme urine antigen tests, which will feed into our FDA submission next year.

So this should not be a barrier for Lp little a measurement.

Lp little a should be measured in whichever way you can with a clinically available CLIA validated assay.

But if we're talking about what's ideal, the molar assay would be ideal.

The other nuance of alkaloid measurement is that there's no precise conversion factor that's been established between converting between milligrams per deciliter and nanomoles per liter.

Let's get started.

Last time we talked about CLIA.

We talked about testing personnel compliance around this.

As you guys know, I'm a pathologist.

It is a real margin, right? So if you're doing hundreds of these tests a month, that can be real revenue.

Now, you only capture it if you perform the test yourself under your own certificate.

You've documented that you have QC and that you put all of that within the claim, right? Not the QC, but the CLIA number on the claim.

And that you really want to make sure that you are actually getting paid for these.

Your teams must determine if an item has successfully transitioned to a conventional marketing authorization, such as a five ten K clearance, or if there are specific guidelines allowing for the continued use of existing on-hand stock.

For clinical laboratories, if you are replacing an EUA-only test, you are still required to complete the necessary CLIA verification or validation for the new test before it's used for patient care.

And for personal protective equipment, specifically respirators, it's crucial to verify NIOSH approval separately from any previous EUA status.

NIOSH certification remains the gold standard for occupational use.