Coagulation Factors

FVIII-depleted Plasma with VWF

Precision BioLogic’s successful Factor VIII Deficient Plasma with VWF is now FDA-cleared for sale in the U.S. [Precision BioLogic supports Fritsma Factor]

Bleeding Disorders

Arabic Numerals?

Frequent FF contributor Dave McGlasson, MS, MLS posted this comment in LinkedIn on 9/7/23. “I have noticed at recent meetings and in some journal articles that coagulation factors are sometimes referred to in Arabic instead of Roman numerals. For example F8 instead of FVIII. Has this been officially proposed as a change by any standardization […]

Coagulation Testing in Hyperviscosity

Rae Kerlin from the Ohio State University Werner Medical Center wants to provide coagulation testing for a patient who has type I cryoglobulinemia [monoclonal IgM kappa]. Rae’s team team ordered a PFA but they were unable to obtain results due to hyperviscosity. PT/PTT = 13.9/24.7. They are planning to test FVIII via the 0ne-stage clotting […]

Bleeding Disorders

Follow-up to “FDA Approves Hemophilia A Gene Transfer Therapy”

This is a follow-up to “FDA Approves Hemophilia A Gene Transfer Therapy,’ posted July 3, 2023, with reference to Dr. Emmanuel Favaloro’s comment, added August 9 and citing Valentino LA, Kaczmarek R, Pierce GF, et al. Hemophilia gene therapy: first, do no harm. J Thromb Haemost. 2023: S1538-7836(23)00501-9. doi: 10.1016/j.jtha.2023.06.016. [click for a copy]. The […]

Bleeding Disorders

FDA Approves Hemophilia A Gene Transfer Rx

Today, July 3, 2023, the FDA approved the use of BioMarin’s Roctavian® [valoctocogene roxaparvovec] for treating adults with severe hemophilia A without inhibitors. The FDA also approved BioMarin’s companion diagnostic, AAV5 DetectCDx, which identifies the patients most likely to benefit from Roctavian. Click here for the LinkedIn announcement. Click here for a provocative FirstWord PHARMA […]

Bleeding Disorders

More on Specimen Storage

Frequent contributor and coag expert Dave McGlasson sent this linked scanned copy of a 1985 article in his state newsletter, “The Texan.” The article documents factor VIII deterioration when stored at –20°C. This is a follow-up to our June 15, 2023 post, Freezing Coagulation Specimens.

Coagulation Factors

Concizumab: Anti-TFPI

On 4-17-2023, Novo Nordisk announced Health Canada’s approval of Alhemo®, their trademark for injectable concizumab, the first anti-tissue factor pathway inhibitor [TFPI] designed to prevent bleeds in Hemophilia A and B patients with inhibitors. The current Canadian approval supports relatively few Hemophilia B [Christmas disease] patients with inhibitors but generalization to Hemophilia A patients could […]

Bleeding Disorders

Precision BioLogic Chromogenic FIX Assay Cleared by the FDA

Congratulations to our sponsor, Precision BioLogic Inc., as their CRYOcheck chromogenic factor IX assay was cleared by the US Food and Drug Administration on January 5, 2023. Click here for PBI’s news release. and click “Factor IX Testing and Introduction to CRYOcheck Chromogenic Factor IX” to register for our February 1 webinar featuring special guest […]

Coagulation Factors

Non-severe Hemophilia Treatment

Here is a meta-analysis of concentrate treatment for mild to moderate hemophilia. Iorio A, Königs C, Reding MT, et al. Prophylaxis use of clotting factor replacement products in people with non-severe haemophilia: A review of the literature. Haemophilia. 2022. doi: 10.1111/hae.14676.

Bleeding Disorders

FDA Approves Gene Therapy for Hemophilia B

Click here for CSL Behring’s press release from November 22, 2022, announcing FDA approval of etranacogene dezaparvovec [Hemgenix] for adult Hemophilia B [factor IX deficient] patients.

Bleeding Disorders

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George Fritsma is a medical laboratory scientist, educator, and author. George holds faculty appointments with Rutgers University and Michigan State University, and is a member of the International Society on Thrombosis and Hemostasis, American Association of Clinical Chemists, and American Society for Clinical Laboratory Science.

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