SALT LAKE CITY, Utah (ABC4 News) – One of the companies recently dumped by the Test Utah program is hitting the market again.
Co-Diagnostics helped start the Test Utah program with its Logix Smart COVID-19 test. The tests were processed at the Timpanogos Regional Hospital Laboratory. In August, ABC4 News told you Nomi Health partnered with Fulgent Therapeutics to continue the Test Utah Program.
The company TNG Dx tells ABC4 News it completed the validation study.
“We would challenge anyone to reproduce these,” TNG Dx Chair Bryan Melgar said. “We wanted to be able to just say, ‘Hey you can reproduce it. Don’t point fingers until you reproduce it. And, you’ll get the same results we have.”
When asked how many validations studies the company completed Melgar said, “We have never done validations for COVID.”
TNG Dx Chair Bryan Melgar
The validation study was conducted by TNG Dx Chief Scientific Advisor Dr. Meghan Lockard indicates the tests are reliable detecting COVID-19.
Melgar adds the Logix Smart Test is low-cost.
“It is high sensitivity and you know, it’s fast processing, and then you know pricing and manufactured in the US. Those are kind of like the trifecta,” said Melgar.
TNG Dx looked into the test while it was apart of the Test Utah program in June.
“We came across Co-Diagnostic’s tests and on paper they, you know, they seemed too good to be true,” said Melgar.
Dr. Lockhard says she was skeptical of the lawsuits and negative press surrounding Co-Diagnostics.
The suit filed in federal court back In June by Gelt Trading Inc. accuses Co-Diagnostics of making false claims about the test being “100%” accurate.
“Co-Diagnostics, its directors and officers… including Ph.D.-level scientists who should know better…made continual, knowing and willful misstatements about their main product, a COVID-19 diagnostic test, to pump up the price of Co-Diagnostics’ stock while the officers and directors exercised low priced options and dumped their stock into the market… Their fraudulent misstatements, and disregard for the basic scientific principles that make their falsity of their statements clear in retrospect, cost investors to lose millions of dollars,” the complaint states.
“What I really had to do was to perform the validation study myself and see for myself,” said Dr. Lockard. “Despite making these accusations, you know, no one had ever actually tested the test, and I found that really interesting and kind of troubling.”
The doctor says she got her equipment from Co-Diagnostics, and an inactive sample of COVID-19 and Influenza B online.
TNG Dx Chief Scientific Advisor Dr. Meghan Lockard
“I got that from a medical supply company BEI Resources, and the reason I did that was because I wanted to perform this limit of detection study and I wanted to know precisely how many viral copies I was starting with.”
We asked the doctor why she would not use an active sample of the viruses.
“There is no difference in the treatment what so ever. Basically, it is just that the virus, the viral sample has been irradiated so that it is no longer infectious,” Dr. Lockard said. “This was tested for cross-reactivity to make sure I wasn’t getting a false signal with an influenza sample opposed to a COVID sample.”
The study created a partnership with CLIA Certified Arches Research, where the doctor found the tests work on different polymerase chain reaction machines.
“I collaborated with Arches while I was doing my own validation study. So I could see how the test performed on different PCR machines. This test works on all open platform PCR machines, which is one of the nice features about it,” she said.
Because there are so many questions about the test, they gave the results to ABC4 News to publish online.
Dr. Lockard adds, “It is there to be critiqued and to be examined.”
ABC4 News reached out to Co-Diagnostics and to representatives for Arches Research to talk about the study, neither company had anyone available to comment.