After Nestlé Health Science sold Prometheus Laboratories in June, the San Diego-based company cut a significant chunk of its staff, laying off 72 employees according to a report with California’s Employment Development Department. But a small cadre of employees are working to advance the diagnostic tests Prometheus was developing for a number of gastrointestinal conditions. The 24-person spinoff, ProciseDx, continues to work for Nestle out of its headquarters in Sorrento Valley.
Larry Mimms, the former chief scientific officer at Prometheus, serves as CEO of the new company. Prometheus’ former chief financial officer, Peter Westlake, is now president and CFO of ProciseDx.
The company’s main focus is to develop two-to-five-minute tests for auto-immune diseases, such as celiac disease, and metabolic disorders, such as diabetes. ProciseDx is taking steps toward regulatory approval in the U.S. and Europe.
The company has begun clinical trials in the U.S. and plans to submit a 510(k) premarket approval application to the FDA in early 2020. This streamlined process would allow ProciseDx to seek an expedited approval for its instrument and one of its assays, if they are substantially equivalent to an existing device that has already been approved.
In Europe, ProciseDx scored a recent victory by obtaining a CE mark for its instrument, which will allow the company to begin beta-testing its platform at facilities within the EU. A CE mark essentially certifies that a product meets the EU’s health, safety and environmental regulations. The company still cannot sell any of its diagnostic assays in Europe until those, too, are CE marked.
"We have been working in stealth mode with Nestlé's support for the last three years to develop this unique point of care diagnostic platform,” Mimms said in a news release. “We are very excited to have the opportunity to build a diagnostics company with revolutionary and disruptive technology and to launch this platform in Europe next year.”