Coagulation Factors

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

Poster: a Handheld Fibrinogen Assay Device

The qLab FIB is a recently introduced handheld point-of-care device that returns a fibrinogen result within ten minutes using a single drop of citrated whole blood.

ISTH Poster: FVIII Deficient Plasma with VWF

Yesterday, July 12, 2022, at the ISTH annual meeting in London, England, the research staff of Precision BioLogic Inc., Dartmouth, Nova Scotia, Canada presented the poster: Kesavan N, Rahman M, Sadeghi-Khomami A, Black KM, Wood A. Performance of FVIII deficient plasma with VWF in the activity measurement of FVIII replacement products in plasma samples using […]

Bleeding Disorders

ISTH Poster: Chromogenic FIX Activity Assay

Yesterday, July 12, 2022, at the ISTH annual meeting in London, England, the research staff of Precision BioLogic Inc., Dartmouth, Nova Scotia, Canada presented the poster: Quinton T, Fraser J, Black KM, Sadeghi-Khomami A. Performance of a chromogenic factor IX activity assay in the recovery of factor IX replacement therapies, Abstract PB1183. Their data illustrate […]

Bleeding Disorders

November 2021 QQ: Case Study, Prolonged PTT, Response

Our November 2021 Quick Question Case attracted 75 responses. We asked, “A 3-YOA female with normal PT and prolonged PTT and no bleeding. What is the most likely deficiency?” Here are your responses: Factor V–3 [4%] Factor VIII–18 [20%] Factor IX–2 [3%] Factor XI–4 [7%] Factor XII–44 [59%] Factor XIII–4 [7%] Congenital factor V deficiency […]

Coagulation Factors

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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.

Cheat Sheets from George

Quick Question