Santa Cruz company gets on FDA fast track for pathogen sequencing method approval
Nearly 3,000 devices receive approval from the FDA each year, according to Pathogenomix Chairman Chris Risley, but only 75 receive a Breakthrough Device Designation.
Patho-Seq, short for pathogen sequence, is Pathogenomix’s new development to identify infections in hospitalized patients more effectively. The recent designation by the FDA gets it on the fast track to full approval, a process which normally takes years, but is now set back by the effects of COVID outbreaks, according to Risley.
“Right now, the FDA is so overwhelmed with COVID tests and everything to do with COVID, they are very slow in processing any other kinds of applications. I think we can all sympathize with that,” he said. “A Breakthrough Device Designation says you’ve got a shortcut, but tis still a very slow path right now. This puts us on an accelerated pathway to the FDA.”
Risley likened the Breakthrough Device Designation to a Fast Pass at Disneyland. Instead of the years it normally takes to receive FDA approval, Patho-Seq is likely to receive approval within a year. However, he said that estimate isn’t even guaranteed with how inundated the FDA is with the pandemic.
Nonetheless, Risley stressed the importance of getting on the procedure on the fast track to approval. Currently, it can only be used in labs that have developed the test for the bacteria DNA. Typically, that is a service that only larger hospitals have access to. Through those labs, Pathogenomix has analyzed more than 400,000 samples since its conception in 2016, Risley stated.
Smaller hospitals, such as Dominican Hospital, don’t have access to that type of testing, and by proxy don’t have access to Pathogenomix’s sequencing procedure. The idea behind FDA approval is to get the technology into every hospital in the nation.
“What this is about is getting an FDA approval so our technology can be used in any hospital in the country, not just these few that have a laboratory developed test,” Risley said.
Risley wants Pathogenomix’s procedure to be available nationwide because of its speed and accuracy in determining infections. That in turn allows doctors to properly prescribe patients and saves the patient time and money.
That factor was a key to Patho-Seq’s designation as a breakthrough device. To receive that designation, the device must assist in the treatment of a life-threatening or life-long health condition, and it must make a major improvement in the standard of care, Risley noted.
Currently, doctors determine if a patient has an infection and what kind of infection it is using a bacteria culture. The response time on a culture can range from a few days to as many as two weeks. Patho-Seq can return the results of a bacterial sample two days faster than a culture.
“If you’re a patient with an infection, two more days of the infection growing is a big deal,” Risley said.
Additionally, a culture does not return a positive result on all types of bacterial infections. Patho-Seq can detect the presence of an infection with 99% sensitivity and can determine the type of infection if 97% specificity, Risley noted.
January 21, 2022
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