Chronus Health, FII’s Newest Company, Poised to Revolutionize $80 Billion U.S. Clinical Laboratory Testing Market

Imagine going to the doctor’s office for your annual check-up. The nurse starts going through the usual tests, such as measuring your blood pressure, heart rate and temperature and completing the blood draw from your arm.

Then the nurse immediately starts testing your blood with a hand-held device, explaining that instead of waiting for the sample to return from the lab, you can receive all your test results in five minutes, allowing the doctor to counsel you on the results right away. This is the future that Fogarty Institute’s newest company-in-residence, Chronus Health, is building today.

Finding a better way to get quick blood test results

While many of our vital signs are easily obtained, unfortunately the one test that doctors rely on to make 70 percent of their diagnoses – the blood test – can take hours, if not days, for results. While blood tests at large healthcare systems are often carried out on-site, in most other settings, such as urgent care clinics, primary care offices and nursing homes, physicians must send samples to a central lab for analysis and then wait until the results are sent back to them to make a clinical decision.

While there are several on-site blood analyzers already available in the market, most clinics are reluctant to buy them based on several factors. First, they are classified as moderate-complexity instruments, which means the clinic needs to hire a qualified lab technician to operate the analyzers. Second, the Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing through the Clinical Laboratory Improvement Amendments (CLIA), which means clinics would have to obtain CLIA certification that involves a rigorous compliance, monitoring and documentation process. Finally, there is the expense of the analyzer itself, with a base unit with limited functionality starting at $15,000 and more sophisticated machines topping out at over $100,000. And of course, the clinics would also then be responsible for costs associated with maintenance, calibrations and reagents.

Chronus Health’s portable device promises to sidestep most of these barriers. Operating with the simplicity of a glucose meter, it provides lab results in minutes, thus allowing for real-time diagnosis, promising to dramatically improve time-to-care and patient outcomes.

The company accomplishes this by replacing complex optical measurements and movement of samples with microfluidics that use only electrical measurements and no mechanical pumps. The entire analysis happens on a disposal test strip the size of a credit card embedded with sensors, which means this technology puts the equivalent of an expensive and bulky blood analyzer in the palm of your hand.

The startup has focused its initial efforts on complete blood count (CBC) and comprehensive metabolic panel (CMP), which make up approximately half of the tests ordered by physicians. CBC can quickly evaluate a patient’s overall health and help detect a broad range of potential disorders, including infection, cancer and anemia; while CMP provides insight on kidney and liver conditions, blood sugar and electrolyte levels.

Building the company based on an unmet need

As often happens, the idea came to its inventor because of a need in his personal life. Ashish Jagtiani, Ph.D., co-founder and CTO of Chronus Health, was working at IBM’s Thomas J. Watson Research Center, focused on semiconductor devices and the development of highly specialized lab-on-chip devices, such as one that detected markers for prostate cancer, when his sister was diagnosed with Acute Lymphocytic Leukemia. After learning she spent the vast majority of her time in the hospital waiting for blood test results, Ashish was motivated to find a better solution for quick results for blood panels. As Ashish shares, “My sister said to me, ‘If you can do something so complex (referring to the prostate cancer detection), why hasn’t someone found a solution for simple, everyday blood panels?’”

He recruited long-time friend and fellow University of Akron bioengineering graduate Anand Parikh, who already had found success in his 10 years of experience, launching several medical devices with FDA and CE mark approvals that generated over $60 million in annual revenue. Together they launched Chronus Health.

The team quickly grew to eight members, each offering a broad range of experiences and backgrounds that have helped the company move quickly and nimbly. “Our cross-functional team is driven by changing the status quo” said Anand. “We are on a mission to accelerate clinical decision making and improve patient care by bringing point-of-care blood testing to every examination room through our innovative technology.”

Joining the Fogarty Institute 

Chronus Health joined the Fogarty Institute earlier this year to capitalize on the available expertise, as the company aims to rapidly get its device to market and then expand its offerings.

“Already we are seeing the benefits of aligning with the Institute’s seasoned team and taking advantage of its individualized mentorship program. We are looking forward to working closely with FII to grow rapidly,” said Anand.

“We are delighted to have the Chronus Health team join the Fogarty Institute,” said Mike Regan, Fogarty Institute CIO. “They are addressing a large unmet clinical need with a novel approach and the passion and energy exhibited by the team in their pursuit of helping patients has been contagious!”

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