Fort Payne Lab Approved by CDC to offer Coronavirus testing

DTPM, Inc. in Fort Payne is a high-complexity CLIA accredited laboratory, assisting clinicians and health care providers to quickly identify the pathogens and underlying causes of diseases.

A Fort Payne based company received approval from the Centers for Disease Control and Prevention (CDC) to offer testing for the COVID-19 coronavirus.

DTPM CEO Gene Cleckler said Friday afternoon that the test will most likely be available for people referred by physicians offices by Wednesday or Thursday. Then they will apply for the FDA’s emergency use authorization. 

“We are very excited,” Cleckler said. Established in 1993, DTPM, Inc. is based on Airport Road in Fort Payne.

Scientists at DTPM started working on their test, or assay, the second week in January when reports of the COVID-19 coronavirus began circulating out of China.

“We had [the test] designed by the end of that first month. It runs great. There were a lot of hurdles to getting this approved. We’ve been like a horse at the gate just waiting to start. There are protocols to validate because this is a public health issue. It’s a little frustrating, but we understand they can’t just let everybody offer a test.”

Cleckler said the pace of developments has been frantic.

“Things have changed daily. A day has felt like a week. We’ve followed the developments and read the literature. Our scientists say we can detect all four of the strains of the coronavirus.”

DTPM’s test involves using a swab similar to a long Q-tip to capture part of the virus from the back of the nose or throat onto the tip. It can be more useful to do a whole upper respiratory panel rather than testing only for COVID-19.

“If you test negative for the coronavirus, you still have to find out the reason for your symptoms if you’re at the doctor’s office for coughing or other symptoms,” Clecker said.

Patients with confirmed COVID-19 infection have reportedly had mild to severe respiratory illness with symptoms of fever, cough, and shortness of breath appearing anywhere from two to 14 days after exposure. Alabama health officials confirmed the state’s first case on Friday morning.

Cleckler is hopeful that the requirement to get the test ordered through a physician’s office will eventually be waived so people can go directly to a lab like DTPM.

“We hope to get it where you can walk into your doctor’s office where we will have installed a lab and within two hours have the test run,” he said. DTPM, Inc. has some labs now in physician's offices, but Cleckler's goal is to see one of the instruments in every physician's office, much like the personal computer is ordinary in every home now. 

DTPM’s COVID-19 resembles the one the CDC has used to diagnose cases of the epidemic.

“[The test] is very similar. They are twins, but not identical twins,” Cleckler said.

He said once testing begins on a more widespread basis , the number of documented cases of people with the coronavirus will go way up, but the positive is that the mortality rate will go down as people self-isolate and assist in notifying anyone around them who might have caught the virus.

Cleckler said the development of the test was important to him as a father of eight.

The Clinical Laboratory Improvement Amendments, passed by Congress in 1988, set forth standards of accuracy governing all medical laboratory testing. CLIA became the basic regulations for all labs involved in testing human samples. DTPM’s in-house laboratory is a CLIA-accredited laboratory and offers comprehensive molecular genetic testing to find specificity for bacteria, viruses, and even parasites.

They are also able to detect antibiotic-resistant organisms. The over-prescription of antibiotics is a problem, Cleckler said.

For more information on DTPM, visit https://www.dtpm.com.

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