The US Food and Drug Administration (FDA) has approved Labcorp’s nAbCyte Anti-AAVRh74var HB-FE assay as a companion diagnostic to Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt).

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, the FDA approved the ARUP’s AAV5 DetectCDx companion diagnostic for BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian (valoctocogene roxaparvovec-rvox). Arup’s companion diagnostic, similar to Labcorp’s assay, detects the presence of nAbs against the adeno-associated virus serotype 5 component of Roctavian gene therapy.

The use and development of companion diagnostics has increased in recent years. Multiple companies have developed companion diagnostics for high-profile therapies. Earlier this month, Roche received a European Union CE mark for the companion diagnostic for Daiichi Sankyo’s and AstraZeneca’s Enhertu (trastuzumab deruxtecan). The Ventana HER2 test can be used to identify patients with low human epidermal growth factor receptor 2 (HER2) expression, who can best benefit from Enhertu.

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Last month, Bayer and Thermo Fisher Scientific entered a collaboration to develop next-generation sequencing-based companion diagnostic assays (CDx). The assays will be used to screen patients eligible for Bayer’s precision cancer therapies.

In November 2023, Pierre Fabre Laboratories partnered with Foundation Medicine to develop companion diagnostics for non-small cell lung cancer. The diagnostic will be used to detect patients who can benefit from Pierre Fabre and Pfizer’s combination regimen of Braftovi (encorafenib) and Mektovi (binimetinib).