FDA approves Labcorp companion diagnostic for Pfizer gene therapy [Yahoo! Finance]
Pfizer, Inc. (PFE)
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Source: Yahoo! Finance
The assay will determine the patient's eligibility to receive Pfizer's FDA-approved haemophilia B gene therapy. Beqvez was approved to treat moderate to severe haemophilia B, a rare genetic disorder characterised by insufficient blood clotting due to a deficiency in factor IX (FIX), leading to prolonged and more frequent bleeding. Labcorp's nAbCyte cell-based neutralising antibody assay detects the presence of pre-existing neutralising antibodies (nAbs), which can interfere with the gene therapy's adeno-associated virus delivery vector and decrease the efficacy of the treatment. A negative nAbCyte test indicates that an individual with moderate to severe haemophilia B can be considered for Beqvez therapy. GlobalData forecasts that the global market for haemophilia A and haemophilia B treatments will grow to $14.7bn by 2030, up from $9.4bn in 2020. Gene therapies such as Beqvez are expected to be significant drivers for this growth due to their significant price tag In June 2023
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PFE
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PFE
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