Precision BioLogic has developed what it says is a better way of detecting levels of substances in hemophilia A patients’ blood that prevent clotting factor therapies from working as well as they should.
It collaborated with Roche and Genentech in creating a kit it says can detect levels of the substances more accurately than other methods. Accurate readings of the substances are important to treatment.
The substances are a reaction to treatments that replace the clotting factor VIII that hemophilia A patients are missing. These factor VIII inhibitors build up in the bodies of about 30 percent of hemophilia A patients over time.
Precision said the kit has the potential to standardize the detection of FVIII inhibitor levels. Doctors can use it to help manage a patient’s disease. And it can be used in clinical trials.
The company discussed the kit at the 4th Biennial Summit of the Thrombosis & Hemostasis Societies of North America in San Diego, March 8-10. The poster-session presentation was titled “Performance of a New Kit for a Modified Nijmegen-Bethesda Assay: Comparison of a Chromogenic Versus a Clot-based Factor VIII Inhibitor Assay in Plasma from Persons with Hemophilia A (PwHA).”
By the end of 2018, Precision plans to ask regulators for permission to sell the kit globally.
“Precision BioLogic has been developing, manufacturing and marketing hemostasis [blood] diagnostic products for more than 25 years,” Paul Empey, the company’s president and CEO, said in a press release. “We’re excited to expand our product offerings and make a meaningful contribution that has the potential to improve the quality of life for people with hemophilia.”
Hemophilia A is caused by genetic mutations that prevent the normal production of FVIII clotting factor, making patients susceptible to uncontrolled bleeding. They require a synthetic clotting factor to prevent bleeding episodes.
But over time almost a third of patients develop inhibitors that prevent clotting factor replacement therapies from working as well as they should.
Doctors need to know the amount of these inhibitors to manage patients’ hemophilia A properly. Detection methods vary from lab to lab, and there is no U.S. Food and Drug Administration-approved gold standard that doctors can use as a reference.
Precision BioLogic took two steps to modify a widely used inhibitor detection method. The first was heating blood samples to reduce the likelihood of faulty results. The second was replacing FVIII-depleted samples with an albumin solution.
The company used the kit to test blood samples from 22 hemophilia A patients and 30 healthy individuals. It proved more effective than other detection methods, Precision said.