Hemophilia Point-of-Care Test Gets Regulatory Ready
Official title: TABA Supplement for Hemophilia Point-of-Care Device
Funded at DNA Medicine Institute · NIH-11405365 · Data updated 2026-11-12
A new point-of-care test for hemophilia A measures FVIII and emicizumab to help doctors manage bleeding risk quickly, with plans to obtain regulatory clearance.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | DNA Medicine Institute NIH-funded |
| Lab location | 1 site (Cambridge, UNITED STATES) |
| Project start | September 10, 2020 |
| Project end | February 28, 2027 |
| Funding year | 2026 |
| Award (this year) | $50,000 |
| NIH project number | 3R44HL151147-05S1 |
| Project ID | NIH-11405365 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates include males with hemophilia A who need frequent monitoring of FVIII or emicizumab-like activity to manage bleeding risk.
✕Less likely to help
Patients without access to routine FVIII/emicallyuom monitoring or those not using this device in their care setting may not directly benefit.
What this research studies
If you or a loved one has hemophilia A, this project aims to finalize a device that can test FVIII-related levels at the point of care within about 15 minutes. The team will arrange outsourced compliance testing and secure intellectual property to move the device toward FDA clearance. The work focuses on preparing the device for real-world clinical use by ensuring safety, reliability, and regulatory readiness. It’s part of a broader effort to give patients faster, on-site information to guide treatment decisions.
Why it matters
Potential benefit: If successful, patients could get rapid, on-site FVIII-like level readings to tailor treatments and reduce bleeding risk.
How similar studies have gone: This project builds on a prior Phase IIB effort toward a market-ready hemophilia test, with regulatory steps still ahead.
Where this research is happening
-
DNA Medicine Institute
Cambridge, United States Active
Researchers
- Principal investigator: Chan, Eugene Yan-Ho — DNA Medicine Institute
- Study coordinator: Chan, Eugene Yan-Ho
Related research
Other NIH-funded projects on the same topics.
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cGMP production of FVIII-making placental cells to help people with Hemophilia A
A new, patient-friendly therapy aims to make FVIII-producing placental cells in the lab to help adults with Hemophilia A, potentially offering a longer-lasting and more affordable treatment.
-
Enhancing immune regulation in gene therapy for hemophilia (new approaches to safer treatment)
A patient-focused overview of a long-running NIH grant exploring how to make gene therapy for hemophilia safer by teaching the body’s immune system to tolerate the therapeutic protein.
-
A safer, longer-lasting gene delivery approach for Hemophilia A using improved nonviral vectors
Researchers are testing a new type of nonviral gene delivery that could provide longer expression of a therapeutic gene for adults with Hemophilia A.
-
Non-viral gene therapy approach to permanently fix hemophilia B
A new gene therapy approach aims to permanently correct hemophilia B without using viruses, potentially reducing bleeding events for people with this condition.
-
Hemophilia A: studying why some people develop inhibitors to FVIII across families
This NIH grant funds a multi-year program to follow families affected by severe hemophilia A to understand why some individuals develop antibodies against factor VIII.
-
Intraosseous delivery of gene therapy vectors for hemophilia A
A gene therapy approach using vectors delivered into bone to help people with hemophilia A reduce or eliminate the need for frequent FVIII treatments.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.