Ever since COVID-19 hit the United States, the ability to adequately test patients has been a constant problem. While availability is part of the problem, methodology and accuracy rates present issues as well.
With roots in clinical and medical diagnostics, biotech company PathogenDx has developed a new ultra-rapid genetics-based testing technology that is could provide relief. Since 2014, the company has been focused on simplifying the process of simultaneously analyzing multiple biomarkers, with initial applications serving the agricultural industry.
Each of the chambers on the PathogenDx Detect test represents an individual sample. In the case of COVID19, when a nasal or throat swab or a throat swab comes in from 12 different patients, labs can test for not just COVID19, but also for SARS, influenza or multiple other issues that commonly present with the same symptoms.
“What's different about what we've developed is that ability to test for up to 10 different viruses, all in the same sample,” he says. “This is important because when people are walking into the doctor's office, ER or urgent care facility, they can be difficult to determine whether it’s a cold, COVID, SARS or influenza. The idea here is to be able to intelligently test to know who is at highest risk.”
The other thing that PathogenDx can do with its testing technology is pool samples. As such, it is possible to swab all four family members and complete the test in one circle. “You can quickly identify those who are likely to be infected,” he says. “It can tell you that the kids are clear, but you could be infected or might be a carrier, and therefore you know it is time to quarantine.”Perhaps the biggest difference maker is PathogenDx’s sensitivity, which leads to much higher accuracy levels. This is crucial considering that the accuracy of the current approved tests can range from 45% to 70%. “These lower levels result in a significant number of false negatives, mostly because they lack enough sensitivity,” says Patel. “In our test it's yes or no.”
The plan is to start rolling out roughly 100,000 tests per month starting in late April or early May. And we'll be scaling up to a million a month. We are currently producing a similar test for agricultural market at a rate of 20,000 per month, so we are confident in our projections.
Although the average COVID test reimbursements is around $51, PathogenDx expects to price its test around $25. “Providers will get much better accuracy, much better specificity, and the ability to test up to 10 organisms or viruses with an answer within three to four hours of a swab,” says Patel.
Patel tells IndustryWeek that PathogenDX’s test does not use as many reagents as other tests, which is reason has been the biggest delay. “We need the FDA to work a little bit quicker on approving these new technologies,” he says.
PathogenDX is also launching its Enviro-x respiratory virus test that will capture the airborne virus. This will allow surgical centers, nursing homes, long-term care facilities or palliative care units to quickly monitor the air and see if the virus is in the air. “This allows you to remediate the air and will ultimately inform you know when is safe to go back in,” says Patel.