rHEALTH’s FVIII Point-of-Care Device Awarded $1.5M Direct-to-Phase II Grant from the NIH

Grant supports efforts to utilize rHEALTH’s point-of-care technology for monitoring FVIII and emicizumab levels in hemophilia A patients

BEDFORD, Mass., October 8, 2020 – rHEALTH LLC, a Diagnose Yourself, Anywhere™ company, announced today that its breakthrough point-of-care testing technology has been selected for funding by the National Institutes of Health (NIH). The award was granted to rHEALTH’s affiliate, the DNA Medicine Institute (DMI), which has provided rHEALTH with commercial rights to the technology.

The focus of this NIH grant is to advance rHEALTH’s next-generation fingertip-based assay platform for rapid monitoring of both FVIII and emicizumab in patients with hemophilia A. The rHEALTH device delivers results in as little as 15 minutes from a tiny sample of blood, leveraging an app-driven, Bluetooth-enabled interface that can be used by clinicians or patients at the point of care.

By contrast, conventional FVIII testing relies on large, complex lab-based analyzers and skilled technicians — limiting access in lower-resource regions and contributing to a global underdiagnosis of hemophilia. These barriers make both treatment and surgical planning highly challenging in many parts of the world.

To ensure real-world impact, two internationally recognized collaborators are partnering on the effort: the World Federation of Hemophilia (WFH) and Boston Children’s Hospital (BCH).

  • WFH, a global leader in advancing care for bleeding disorders, will help guide field deployment and testing in developing regions.

  • Boston Children’s Hospital, ranked the #1 pediatric hospital in the U.S. by U.S. News & World Report, will benchmark device performance against gold-standard lab analyzers and extend testing accessibility to its hemophilia patients.

“The rHEALTH point-of-care technology has the potential to transform the diagnosis and monitoring of hemophilia A worldwide,” said Alain Baumann, CEO of WFH. “A simplified, portable solution for monitoring FVIII and emicizumab will significantly widen access to care, replacing today’s highly complex and hospital-bound testing models,” added Glenn Pierce, MD, PhD, WFH VP of Medical.

rHEALTH CEO and inventor Eugene Chan, MD, stated:

“We are committed to delivering a patient-friendly, accessible solution that empowers individuals to manage their condition easily and effectively. Hemophilia patients deserve testing that matches the urgency of their realities.”

The rHEALTH device is an award-winning, patented platform that utilizes rHEALTH’s CE-marked two-stage fluorogenic assay for FVIII monitoring, providing precise measurements across a broad dynamic range (<1% to 200%).

About rHEALTH®

rHEALTH is focused on commercializing its Diagnose Yourself, Anywhere™ technology — a universal blood testing platform capable of running multiple assays from a single tiny sample. The technology has been recognized in multiple XPRIZE competitions and is actively being evaluated by NASA for astronaut health monitoring.

Visit: www.rhealth.com

About DNA Medicine Institute

The DNA Medicine Institute (DMI) is a biomedical incubator advancing breakthrough healthcare technologies funded by NASA, NIH, and the Bill & Melinda Gates Foundation. Its mission is to accelerate life-improving innovation across diagnostics, therapeutics, and global health applications.

Visit: www.dnamedinstitute.com

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