EnzySystem for hemophilia A could make home clotting tests easier
But patients, clinicians say accuracy of blood-testing device will be key
- EnzySystem is a new device being developed for hemophilia A to allow easier, faster home blood clotting testing.
- The device measures factor VIII activity and could be used to help prevent bleeds.
- Patients and clinicians say they support the idea, but will require proven accuracy before the device's widespread adoption.
People with hemophilia A and their caregivers, as well as healthcare providers, have shown a strong interest in a new blood-testing device being developed to make blood clotting tests faster and easier to access, according to a recent study.
The device, called EnzySystem, allows for measuring the activity of factor VIII — the blood-clotting protein missing in hemophilia A — along with a key marker of clotting ability (thrombin), using a small blood sample. The test takes about an hour, the researchers noted. Versions are being designed for both clinic use and home testing.
The researchers noted that participants in the study, especially patients, found home testing to be the most appealing option, as it provided easier and faster access to results. According to the team, this could support more frequent and meaningful monitoring.
However, both patients and clinicians said clear proof of accuracy and the opportunity to try the device would be essential before they would trust and adopt it.
“The results of this study support the further development of the EnzySystem for haemophilia A,” the researchers wrote, adding that future work should focus on “generating conclusive evidence of accuracy, followed by facilitating trial use of the EnzySystem.”
The study, “Acceptability and Determinants for Implementation of the EnzySystem, a Novel Near-Patient Testing Platform for Haemophilia A,” was published in the journal Haemophilia by a team of researchers in the U.S. and the Netherlands. The study was funded by Enzyre, the device’s developer, which states on a company webpage that its vision is “bringing the lab to the patient.”
Hemophilia A is caused by a deficiency in factor VIII, or FVIII, a protein needed for blood clotting. That deficiency leads to spontaneous and prolonged bleeding among patients.
To prevent bleeds, people with hemophilia A rely on factor replacement therapies, which are regular FVIII infusions into the bloodstream. To avoid over- or underdosing, treatment should be ideally adjusted using blood tests that measure FVIII pharmacokinetics (PK), which indicates how long the factor remains in the body.
Although PK-guided dosing is recommended by international guidelines, it is frequently omitted due to limited access to specialized laboratories and long turnaround times. As a result, treatment decisions are frequently based on perceived bleeding risk, clinical judgment, or patient preference.
“Moreover, lacking testing availability contributes to underdiagnosis of bleeding disorders, including haemophilia A, in resource poor countries, highlighting the need for accessible and
reliable testing options,” the researchers wrote.
EnzySystem aims to allow easy blood clotting testing at home
EnzySystem, billed as a “handheld microlaboratory,” aims to address this gap. The device enables rapid measurements of FVIII activity and overall blood clotting capacity from a small blood sample in clinical or home settings.
“This study focuses on the EnzySystem’s acceptance, envisioned use, and determinants for implementation according to healthcare providers (HCPs) and [people with hemophilia A],” the researchers wrote.
The team surveyed 36 people with hemophilia A or their caregivers, as well as 22 healthcare providers, using three questionnaires and two in-person focus group discussions. All were done at a hemophilia treatment center in Indianapolis. Most study activities took place during single study visits held between Aug. 22 and 24, 2024.
In the patient and caregiver group, most participants were people with hemophilia A (72%), with the remainder being caregivers (25%) or a patient-caregiver pair (3%). Participants were mostly male (83%), and 69% were on preventive treatment.
The healthcare provider group was comprised of nurses (36%), advanced practice providers (23%), hematologists (23%), and pharmacists (18%).
Study finds 8 of 10 patients, caregivers willing to use new device
Acceptance of the EnzySystem was high, according to the researchers. Among patients and caregivers, willingness to use the system had a median score of 8 of 10. Nearly all (94%) said they would test more often if the device were available, and 86% said they would be willing to pay for it.
The responses from the healthcare providers followed a similar trend: 86% gave the highest possible excitement score, and more than two-thirds (68%) — including all physicians — said they would use the device in their daily practice.
Home testing was the most favored use scenario, supported by 97% of patients and preferred over clinic testing by both groups, including 81% of patients and 60% of providers.
Across both groups, accuracy was ranked as the most important feature. In the focus groups, participants said that clear evidence of accuracy and opportunities to try the device would be key for building trust and supporting adoption.
Involving end-users throughout the development ensures innovations are well-suited to meet real-world clinical needs.
Participants also stated that easier access to testing and timely results would enable more frequent monitoring, which patients believed could help prevent bleeds and provide reassurance before engaging in activities. Clinicians, meanwhile, saw particular value in targeted testing, such as before surgery or after treatment.
While patients welcomed the possibility of greater independence through home testing, most stressed the need to stay connected with their hemophilia treatment center when interpreting results and making treatment decisions. Providers also raised concerns about unsupervised self-testing.
Overall, the study’s results support advancing the device’s development for hemophilia A, and also “highlight barriers that should be addressed to facilitate implementation,” the researchers concluded.
“Involving end-users throughout the development ensures innovations are well-suited to meet real-world clinical needs,” the team wrote.
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