JPM23: 'What has the pandemic done for us?' Freenome and other diagnostics developers on making tests more accessible

SAN FRANCISCO—If there’s one silver lining to the COVID-19 pandemic, it’s the amount of rapid innovation that occurred across medtech, biotech and healthcare to better serve patients who had either caught the coronavirus or were staying away from traditional points of care to avoid it.

Diagnostics developers, in particular, made the long-standing dream of easy-to-access, highly accurate tests come true—and over-the-counter COVID swabs were just the beginning. In interviews with Fierce Medtech during the annual J.P. Morgan Healthcare Conference on Monday, leaders from Freenome, Babson Diagnostics and Immunexpress discussed their ongoing plans to make a wide range of blood tests as broadly accessible and as simple to use as possible.

For Freenome, for example, that means partnering with CVS, Cerner and other collaborators that are already embedded within patients’ communities and local healthcare systems. That approach is what will help bring the company’s early colorectal cancer screening test to “the forefront of clinical care,” CEO Mike Nolan said.

“The pandemic has proven that patients want us to meet them somewhere else, in addition to the healthcare system,” he continued, highlighting Freenome’s aim to cater to patients via alternative points of care such as retail pharmacies, telehealth platforms and federally qualified health centers.

That’s one key way in which Freenome is answering the all-important question of “what has the pandemic done for us, in terms of what we need to learn from it and apply going forward?” according to Nolan. That question currently poses both opportunities and challenges across all of medtech, he said, and will serve as a major catalyst for much of the industry’s growth—and Freenome’s own expansion plans—throughout 2023 and beyond.

Also rising to the challenge is Babson Diagnostics, maker of a simplified blood collection device and accompanying suite of tests.

“COVID showed us that having accessibility to diagnostic testing is super critical, and it's funny, people would always say, ‘There has to be a better way to get your routine blood testing,’” said Babson CEO David Stein, Ph.D. Those concepts have now combined to ask how diagnostics developers can “bring the high accessibility of rapid testing, of point-of-care, but couple that with the menu breadth of what you can get at a Labcorp, Quest or a Central lab,” he said.

That once-unattainable coupling is now within reach, thanks to a “truly reimagined end-to-end process,” per Stein, comprising the fingertip blood-collection device Babson developed in partnership with BD, a fully automated and Babson-developed process of centrifuging the blood and work with Siemens Healthineers that allows a range of tests to be run on a relatively small sample of serum.

That overhaul of the current status quo in routine blood tests is in keeping with an ongoing healthcare trend Stein identified: “They want high accessibility, but no longer are people willing to deal with ‘just good enough.’”

Immunexpress, meanwhile, is hoping to take advantage of the somewhat slow reaction to pandemic-induced pressures in its own corner of the diagnostics sector.

The startup has developed an FDA-cleared PCR test to detect sepsis in adults, with plans to expand that indication to pediatric patients this year, according to CEO Rolland Carlson, Ph.D.

Not only does the test represent an entirely new market area, and “one that’s going to change some clinical practice,” Carlson said, but Immunexpress is also leading the pack when it comes to developing new diagnostics for infectious diseases—though he's hoping the company's peers will soon follow suit as a "tsunami of antibiotic resistance" ebbs ever closer.

“I see many novel tests coming out on the oncology side, and not as much as far as the infectious disease side,” Carlson said. “But the pandemic proved this: You need to have very efficient, highly sensitive tests. And the utility that molecular diagnostics bring to the table for infectious disease is very important, as evidenced by what we went through.”