The numbers are going to go up consistently because our testing is way behind the reality of what the situation is.

I have no doubt that the reality is a multiple of everything we're seeing in the numbers.

And as we test more, that's what you're going to see.

That's New York Governor Andrew Cuomo explaining why he made the City of New Rochelle a partial containment

zone against the novel coronavirus that causes COVID-19. The lack of enough testing has made it

impossible so far to determine the extent of the pandemic in the United States. Now, clinical labs are trying to make tests available. One is

Topa Diagnostics in Southern California, where Dr. Edward Blackman is Director of Clinical

Pathology. And doctor, thanks a lot for taking the time to be with us. Yes, thank you for

having me. Tell us where you and other clinical labs are at this point,

and to what extent testing is now being made available? Well, testing is available at the two

largest national labs, Quest and Lab Corp, and other clinical labs around the country, such as ours,

are attempting to bring the test in-house, which generally

means working with an in vitro diagnostic manufacturer. These companies have developed

tests, and more are developing the tests, and they're currently available, but are not

FDA approved.

So to use one of the tests that are currently being produced by the in vitro diagnostic manufacturers,

independent labs will be required to validate the tests ourselves.

So you can't do that at the moment.

To what extent we've heard a lot about the FDA,

the Federal Drug Administration, and the Centers for Disease Control as well. Have they made it

difficult to get the testing underway? Well, the FDA requirements do slow down the process and the approval by the FDA for tests that are manufactured

and distributed by the IVD companies.

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