Approval could lead to wider testing needed to open economy

By Mike Ramczyk


According to new analysis by Harvard researchers, COVID-19 testing must be ramped up across the country before the restaurants, bars and other establishments can safely reopen to the public.

Due to unreliable tests and a shortage of tests, not nearly enough people have been screened for coronavirus, they contend.

In order to reopen states safely, according to the analysis, new cases of the virus must be caught to prevent resurgence once numbers begin to decline.

Nathan Libbey

Enter Nathan Libbey.

A 2001 Burlington High School graduate, Libbey is the Business Development Director at Pathogen DX, a laboratory based in Tucson, Arizona.

Libbey works remotely from his Burlington home, where he, along with a host of scientists and other experts, have come up with a new test for coronavirus, just in time to help the country recover from the pandemic.

“This was our long-term goal, clinical diagnostics,” Libbey said Tuesday. “We were working on food and ag applications, with probes printed to capture our good friends listeria and salmonella as well as other plant viruses.”

“Given the need to test and eventually reopen our economies, schools, and infrastructure, we really didn’t have a choice but to pivot, rapidly.”

Libbey said the country wasn’t ready for this pandemic, as the bulk of tests have lower sensitivity and accuracy. In addition, the tests have been limited to people with symptoms, those who’ve been exposed to someone with COVID-19 and frontline workers.

Higher volume, more people can be tested

“We are scrambling to test as many as possible,” Libbey said. “This option, when scaled, will allow for thousands of tests to be performed by one system. We are also in trials of a pooled option, that is we pool together 10-12 samples in one test.”

“If it is negative, all in the pool are cleared. If positive, we rerun all samples individually. This would greatly reduce much of the logjam in the supply system, as the chemicals used in each test are in high demand and backordered in many cases.”

The test Pathogen DX is creating is a microarray – about 150 small probes (dots) are printed into a dime-sized spot on a standard microscope slide. Each spot has three sets of the same probes, so the test is run in triplicate to ensure high accuracy.

Each probe is designed to stick to a target, in this case a virus. If the virus is present in a sample, it sticks to a probe. Slides are then scanned by a computer and if the probe lights up, the sample is positive for the virus.

“The amazing thing about using microarray is that we can print several targets on one dime-sized well,” Libbey said. “For our SARS-CoV-2 (the virus that causes COVID-19), we also have several other viruses printed, including SARS, MERS, and influenza strains.

“While we are hyper-focused on looking only for SARS-CoV-2 now, in the future we can, in a rapid fashion, diagnose a sniffle in a matter of a couple of hours. With this data, we can quantify risk as well as better contract trace and, ideally, eliminate a virus before it spreads.”

Libbey said they submitted the test to the Food and Drug Administration for Emergency Use Authorization on April 16.

The average turnaround has been 15 days on approval, so he expects to hear soon whether the test has been approved.

To read the entire story see the April 30 edition of the Burlington Standard Press.