As the fight against the COVID-19 outbreak wages on, the need for more efficient and readily-available testing continues to be at the forefront of the issues facing the United States. Help could soon be on the way, however, thanks to Trax Management Services, a medical logistics company in Delaware and a member of the Delaware Entrepreneurial Center.
On May 1, the company announced the introduction of the PhoenixDx 2019-nCoV test kits to North America after they received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) in late April.
“This is the gold standard test that is used to diagnose the (novel) coronavirus in patients,” said Dr. Rakan Qazziha, the chief science officer at Trax. “This is not an antibody rapid test, not an antigen rapid test. This is done in a lab setup with nasal pharyngeal, like swabs from the nose, taken from the patients.”
After the sample is put through some cycling, Qazziha said a genome of the virus is created, which can then be analyzed for the existence of the virus. The entire process takes a total of approximately 90 minutes to determine whether a sample is positive or negative.
“Right now on the market, there are two types of testing,” Qazziha said. “There’s the rapid test, the pin-prick test where you get a bit of blood and you wait 15 minutes for the results. The problem with that test is it has a high chance for false results — a 40% chance the patient will get a false result … it’s kind of risky to use this test.”
The PhoenixDx utilizes real-time reverse transcription-polymerase chain reaction (RT-PCR) that amplifies the virus genome. The tests contain the reagents to facilitate the PCR which, after cycling, will show through computer software if the virus is present.
Qazziha said the tests offer a 100% sensitivity rate and have 100% specificity, meaning there is no chance for a false result. During the clinical trial, the tests were used on 200 patients and showed 100% accuracy, he said.
While an antibody test result will show if a patient has encountered the virus, regardless of whether or not the virus is active, the RT-PCR test will show whether or not the virus is active in the sample.
Qazziha said another benefit of the tests is that they are compatible with all the molecular analyzers labs should already possess, meaning no specific device is needed in order to utilize the PhoenixDx tests.
Prior to the EUA by the FDA, PhoenixDx has already been used all over Europe and was recently sold in New Zealand. The tests are manufactured in Austria by Procomcure, a biotech company that has been producing in vitro diagnostics for 25 years. Procomcure is able to manufacture one million tests per week, Qazziha said, with the ability to utilize twin companies to boost that number to five million tests per week based on demand.
Qazziha said they are in talks with many medical chains within the United States to order the tests, with a “high potential” for the product to begin use in America soon.
“We are excited to do our part and help to meaningfully address the national need for increased testing,” Dave Curley, of Trax, said in a press release. “This test is currently being used in hospitals and labs across the European Union to detect the novel coronavirus — with stellar clinical results. We are proud to be able to offer it here in the United States.”
Trax’s Robert Holmes said it is really cool that a service-disabled veteran-owned small business (SDVOSB) was able to accomplish such a tremendous feat.
“Certainly, you have the expectations of a large business like Abbott or Roche to step up to the plate and make things like this happen,” Holmes said. “But for us to pull a team together and take this through a complex process with the FDA and get this all validated at the level that it is, and set up production to be able to fulfill demand … it’s a tremendous accomplishment for us at this point, to be able to go down this path and bring these tests to the United States.
“It’s unbelievably fulfilling to know that a small business can put their heads down, through many sleepless nights … To make this happen is a real star on the landscape of the small business world. In these situations, we oftentimes look to big business for support, but the small businesses have just as much power, and this is a perfect example of that.”
Delaware Economic Development Director Sean Hughes said of Trax’s accomplishment, “Amazing innovation and creativity are happening in our community every day. Our Delaware Entrepreneurial Center at Ohio Wesleyan University has been a great boost to making sure that these things are given the support necessary to achieve a new company’s goals. The city of Delaware is a place where dreams can become reality.”
Reach Dillon Davis at 740-413-0904. Follow him on Twitter @DillonDavis56.