A Fort Payne company that has long been primarily in the business of designing and equipping drug testing labs across the country has shifted focus to delivering a newly approved COVID-19 test to labs nationwide. And the laboratory and regulatory hurdles have been a lot easier to clear than access to the most basic equipment, such as cotton swabs, needed in the testing process.
The FDA granted DTPM (Data Test Program Management) approval for its test under its emergency use guidelines, adopted by the FDA to promote new assays capable of diagnosing COVID-19. DTPM began using the test through its subsidiary Tide Laboratories on March 23.
DTPM, founded in 1993, sets up laboratories and supplies them with tests, or assays. Most of those products have been toxicology tests going to labs at medical facilities, physicians’ offices and drug courts, but the company also has long been involved in viral and bacterial pathogen testing, using the Polymerase Chain Reactions (PCR) test, the genomic-based test now being used to detect the strain of coronavirus said to be causing COVID-19.
Over the years, DTPM has developed over 130 molecular assays, four of which detect other strains of the Coronavirus (Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63 and Coronavirus OC43).
Business Alabama interviewed DTPM CEO Gene Cleckler to get the details on what his company is now doing.
What is the volume of this product that you will be producing?
We produced an “assay” or “test” for COVID-19 named DTPM-COVID-19 and have been running it in Tide Laboratories LLC since March 23rd. We have approximately 120,000 assays in our lab and have ordered another 120,000 to be used by our lab and others. Getting more assays is not difficult. One issue we have is all the other supplies that are required in the chain of the testing. Swabs and other items that we have been able to maintain some inventory but many of them are of a concern.
Where is the demand coming from?
Our demand comes from our laboratories that are also our customers. We don’t test for what we refer to as “Doctor to Lab.” We test for our laboratory customers in different states. “Lab to Lab” testing for those that either don’t have the capacity to test what they are getting or for some test that they don’t offer but that we do.
What did you have to do to focus Tide Laboratory facilities on this product?
DTPM designs and sets up molecular “PCR” laboratories. Tide has been primarily a research laboratory, where we validate the assays that DTPM designs. This was a natural progression to design this assay. We completed the design in late January and had it ready for testing in late February. We then had to complete the FDA validation process and started testing on March 23rd. There are still steps with the FDA that we are following.
How difficult is this product to make?
Not being a scientific person I would say very difficult. However, my staff seem to make it look easy. Most companies buy assays off the market, but our company designs and sets up a laboratory developed test in our customer labs. We provide this to physicians’ offices and reference laboratories — anywhere they have a highly complex laboratory.
How difficult is it to use this product — to employ it effectively and accurately.
All our laboratory products, whether toxicology or molecular, are run in laboratory environments with the correct level of licensure of the laboratory and staff to fit the method. So, as long as the staff is properly qualified, they should be able to use the product as our operating procedures outline. We spend a lot of time training the staff to assure they can run the specimens effectively and accurately.
What guidance and facilitation did you get from the FDA to make these tests?
They put out some very clear guidelines on all EUA products. There are many different type products related to COVID-19. They set very clear guidelines for each. They have been very responsive to our questions, and, where they needed more data, we have provided that to them as well. They don’t give guidance in “making the test,” but they do on validating that the test performs accurately and effectively.
What other companies do you know of in Alabama that are producing such tests?
It is hard to tell what other laboratories are using. Some use the assay that the CDC developed, and I am not sure if others are using assays from vendors or if they have the ability to develop their own.
