The assays complement the LeukoStrat CD脳 FLT3 Mutation Assay, which informs treatment choices for patients with acute myeloid leukaemia. Credit: Papa Annur / Shutterstock.

Invivoscribe’s subsidiary, the Laboratory for Personalized Molecular Medicine (LabPMM), has secured New York State (NYS) approval for the NPM1 MRD Assay, marking an advancement to combat acute myeloid leukaemia (AML).

This decision comes after the NYS approval for the company鈥檚 FLT3 ITD MRD Assay two months ago.

These standardised next-generation sequencing (NGS) assays are said to offer a toolset for clinicians, individuals, and pharma companies.

The NPM1 MRD Assay claims to deliver an ultra-sensitive DNA sequencing method to detect minimal residual leukaemia cells in those with nucleophosmin 1 (NPM1) mutation variants.

Given that these mutations are found in approximately 30% of adult AML cases and are stable over time, their presence at allele fractions of 0.01% or higher is said to be linked to increased relapse risk and poorer overall survival.

According to the company, recent studies have highlighted the importance of measurable residual disease (MRD) testing for NPM1 and FLT3-ITD in detecting AML subjects in remission who are at a higher risk of relapse or poor survival outcomes.

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The use of MRD as a surrogate endpoint in trials allows pharma firms to expedite the development processes of the drugs, which is crucial in acute diseases.

NPM1 and FLT3 ITD MRD Assays complement the LeukoStrat CD脳 FLT3 Mutation Assay, which informs treatment choices for patients with AML.

These services are available in the European Union, the US, and Asia, ensuring global access to standardised testing and supporting the advancement of treatments for cancer.

LabPMM global clinical laboratory operations vice-president Jordan Thornes said: 鈥淲e are proud to receive NYS approval for our聽NPM1聽MRD Assay by NGS, marking our second assay approved by NYS this year.

鈥淭his milestone reflects our continued dedication to advancing precision diagnostics in cancer care. With this latest approval, we鈥檙e further empowering clinicians with sensitive, reliable tools to detect residual disease and guide treatment decisions with confidence.鈥�

In 2023, Invivoscribe secured In Vitro Diagnostic Regulation (IVDR) approval for its polymerase chain reaction (PCR)-based LeukoStrat CD脳 FLT3 Mutation Assay.

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