The peer-reviewed grant funding will accelerate FDA approvals for these blood tests.
Bedford, MA, January 14, 2025 . rHEALTH today announced that its two coagulation tests are being funded by $5M from two National Institutes of Health (NIH)/National Heart Lung and Blood Institute (NHLBI) grants. The awards are to rHEALTH’s affiliate, the DNA Medicine Institute (DMI), which has granted rHEALTH all commercial rights to the technology. This funding will accelerate the FDA approval of these critically needed point-of-care tests.
The funding for rHEALTH’s hemophilia tests are to further develop the company’s fingerstick-based point-of-care technology for measuring FVIII and emicizumab levels. This is funded via a $3M NHLBI Phase IIB Bridge Award to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases. The second grant, a $2M Direct to Phase II SBIR award, will fund efforts to develop a rapid test for measuring anti-factor Xa activity for patients taking oral anticoagulants such as Eliquis® and Xarelto®.
Hemophilia A is an X-linked recessive genetic disorder with an incidence of 1 in 5000 live male births. For these patients, lifelong treatment is required to provide adequate and therapeutic FVIII or emicizumab FVIII-like levels. FVIII replacement monitoring is essential to maintaining optimal dosing. Acute bleeding and surgeries require knowledge of FVIII and/or FVIII-like levels for proper management. Testing challenges have resulted in hemophilia being greatly underdiagnosed in many countries around the world. Management of patients on anti-factor Xa inhibitors is also a pressing issue. Over 16 million patients currently take factor Xa inhibitors and of these over 500,000 patients experience major or life-threatening bleeding or strokes. Time-to-result is critical to administer lifesaving interventions. rHEALTH’s tests for hemophilia A and for anti-factor Xa activity return results within minutes, providing accurate data for time-critical clinical decisions.
“We are on a mission to improve patient care by providing broader access to tests which are conventionally limited to central labs. Tests for patient samples with hemophilia A and those on anti-Xa inhibitors are typically limited to specialized central laboratories. Our rHEALTH technology advances the field by allowing these tests to be performed by patients and caregivers alike,” said Eugene Chan MD, CEO of rHEALTH.
About rHEALTH
rHEALTH is a company focused on the development and commercialization of its Your Health, AnywhereTM technology The rHEALTH blood sensor is the subject of XPRIZE awards, NASA contracts, multiple issued patents, and a gravity-defying demonstration on the space station. For more information, visit www.rhealth.com.