“These kinds of situations remind people how important diagnostics are,” Hawkins told BioSpace in an interview.
Hours before the U.S. Food and Drug Administration granted Emergency Use Authorization to California-based Cepheid’s rapid Xpert Xpress SARS-CoV-2 point-of-care diagnostic, Jeff Hawkins, chief executive officer of Truvian Sciences, noted that in all of the industry response to the pandemic, approval of such a device was still missing.
“These kinds of situations remind people how important diagnostics are,” Hawkins told BioSpace in an interview.
Hawkins and his team at Truvian have been meticulously developing an automated benchtop system that is designed to provide accurate lab results within 20 minutes from a small blood sample. The benchtop system, about the same size as a computer processor tower, is capable of conducting a full suite of diagnostics tests. The benchtop system combines chemistries, immunoassays and hematology assays in one device. The capabilities of the company’s device could be applied to the testing of coronavirus, seasonal flu or some kind of infectious agent, Hawkins said. Although the company is currently not building its device with that kind of testing in mind, Hawkins said they are cognizant of what is happening with the pandemic and did not rule out including such needs in the future.
“We have the platform that you need for that,” he said.
With the current coronavirus pandemic, Hawkins pointed to the work of companies like Roche, Thermo Fisher, Abbott and Cepheid as companies that can provide immediate need to the industry. Each of these companies have received FDA-approval for diagnostic devices, with Cepheid’s device capable of providing a diagnosis within 45 minutes. While those devices are benefitting, or soon will benefit, treatment options for COVID-19, the disease caused by the novel coronavirus, Hawkins said Truvian’s automated, benchtop diagnostic system that is designed to provide results for a comprehensive suite of health tests within 20 minutes is a long-term solution.
While no one wants another pandemic, Hawkins said it’s best to be prepared. To that end, Truvian has been in discussions with some undisclosed agencies that are providing grant money for long-term infrastructure investments for rapid-response solutions to future pandemics. With its smaller size, Truvian’s device can be easily set up in an office setting, or even in a pop-up drive-by testing site, much like is being used today in the coronavirus outbreak.
“It would be ideal if you got swabbed and 20 minutes later you were given your results and could then proceed with your care,” Hawkins said. “This is what excited me about what we’re doing. In the end, we could be placing these devices in thousands of places and do some testing on the spot.”
Hawkins also noted that Truvian’s device could be tailored to perform a serological result to “really provide a broad overview.” It’s these kinds of capabilities that “remind people how important diagnostics are,” he added.
The company continues to play the long-game though, as it is striving to drive its device through the regulatory channels. Hawkins said Truvian is “feeling its way along” and deploying beta machines as they move closer toward potential approval. Hawkins said the company’s pace is moderated and noted that the current working conditions under a statewide lockdown in California could slow things down a bit. Hawkins lauded the actions of Gov. Gavin Newsom to implement the lockdown to slow the spread of the virus in California. He said it was the right thing to do for the safety of employees and the company is doing its share to comply. Hawkins said it is difficult, but Truvian is limiting the number of employees who work within its labs at a given time in order to maintain social distancing standards. Unlike many companies where remote work isn’t much of an issue, Truvian, and other medtechs, rely on scientists and engineers having access to a laboratory.
“We’re taking proactive steps in letting those who can work remotely and stagger shift in the labs,” Hawkins said.
