Marstacimab ELISA Kit

Catalog No.

KDC82803

Description

PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human TFPI has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Marstacimab in the sample competitively binds to the pre-coated protein with biotin-labeled Marstacimab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Marstacimab bound in the initial step. The color development is stopped and the intensity of the color is measured.

Applications

Used for the quantitative determination of Marstacimab concentration in serum and plasma.

Detection method

Colorimetric

Sample type

Plasma, Serum

Assay type

Quantitative

Range

31.25 - 1,000 ng/mL

Sensitivity

39.99 ng/mL

Precision

Intra-Assay Precision (Precision within an assay): <20%

Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.

Inter-Assay Precision (Precision between assays): <20%

Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.

	Intra-Assay Precision			Inter-Assay Precision
Sample	1	2	3	1	2	3
n	16	16	16	24	24	24
Mean (ng/mL)	574.2	120.8	47.5	463.0	118.3	46.5
Standard deviation	50.2	12.8	8.1	33.1	14.9	9.3
CV (%)	8.7	10.6	17.1	7.2	12.6	19.9

 

Recovery

80-120%

Shipping

2-8 ℃

Stability and Storage

When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%.

Alternative Names

PF-06741086, CAS: 1985638-39-8

Background

Marstacimab, previously known as PF-06741086, is a fully human monoclonal antibody IgG1 antibody that binds to the K2 domain of TFPI at nanomolar to suprananomolar concentration ranges. Non-clinical experiments demonstrated that marstacimab could enhance thrombin generation in vitro and in vivo in a concentration-dependent manner. In vitro thrombin generation assays (TGAs) and dilute prothrombin time (dPT) assays evaluating Marstacimab added to donor plasma from healthy normal volunteers and patients with haemophilia A, haemophilia B, and haemophilia A with inhibitors have all shown the ability of marstacimab to increase coagulation activity and promote haemostasis. Bleed control was demonstrated in severe injury mice models of haemophilia A and B.

Anti-tissue factor pathway inhibitors for hemophilia: are these treatments the answer to overcoming current treatment limitations?, PMID:40515600

Concizumab (Alhemo) for hemophilia A and B with inhibitors., PMID:40324964

Revolutionizing Treatment Strategies through Inhibition of Tissue Factor Pathway Inhibitor: A Promising Therapeutic Approach for Hemophilia Management., PMID:40200623

Consistent clinical factor VIII equivalency is unlikely for non-factor therapies in hemophilic mice., PMID:40176760

Novel drugs approved by the EMA, the FDA and the MHRA in 2024: A year in review., PMID:39971274

Marstacimab (Hympavzi) for hemophilia A and B., PMID:39752723

Marstacimab-hncq., PMID:39719032

Marstacimab: First Approval., PMID:39715914

Advances in Development of Drug Treatment for Hemophilia with Inhibitors., PMID:39698264

Hympavzi (Marstacimab-hncq)., PMID:39694756

Non-factor Therapies for Hemophilia: Achievements and Perspectives., PMID:39613145

Benefits and risks of non-factor therapies: Redefining haemophilia treatment goals in the era of new technologies., PMID:38481077

Non-clotting factor therapies for preventing bleeds in people with congenital hemophilia A or B., PMID:38411279

Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab., PMID:37610502

Safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of marstacimab in Chinese participants with severe haemophilia., PMID:37339017

The Use of Bypassing Treatment Strategies in Hemophilia and Their Effect on Laboratory Testing., PMID:37146647

Long-term safety and efficacy of the anti-tissue factor pathway inhibitor marstacimab in participants with severe haemophilia: Phase II study results., PMID:36220152

A phase 1b/2 clinical study of marstacimab, targeting human tissue factor pathway inhibitor, in haemophilia., PMID:35999026

The Vascular Endothelium and Coagulation: Homeostasis, Disease, and Treatment, with a Focus on the Von Willebrand Factor and Factors VIII and V., PMID:35955419

Current and future therapies for haemophilia-Beyond factor replacement therapies., PMID:35869698

Anti-TFPI for hemostasis induction in patients with rare bleeding disorders, an ex vivo thrombin generation (TG) guided pilot study., PMID:35525014

Hemostatic efficacy of marstacimab alone or in combination with bypassing agents in hemophilia plasmas and a mouse bleeding model., PMID:35316941

Progress in the Development of Anti-tissue Factor Pathway Inhibitors for Haemophilia Management., PMID:34026796

Practical considerations for nonfactor-replacement therapies in the treatment of haemophilia with inhibitors., PMID:33742707

Marstacimab, a tissue factor pathway inhibitor neutralizing antibody, improves coagulation parameters of ex vivo dosed haemophilic blood and plasmas., PMID:31336410

Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody., PMID:30927117

A first-in-human study of the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06741086, an anti-tissue factor pathway inhibitor mAb, in healthy volunteers., PMID:29908043

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