Invivoscribe, a global leader in precision diagnostics, has successfully registered its LeukoStrat CDx FLT3 Mutation Assay with regulatory authorities in both the United Kingdom and Switzerland. This regulatory milestone expands access to critical diagnostic testing for patients with acute myeloid leukemia (AML), enabling more precise treatment selection and improved patient care.
The diagnostic assay has received official registration from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Switzerland's Swissmedic. Regulatory compliance was achieved through Invivoscribe's UK Responsible Person (UKRP) and Swiss Authorized Representative (CH-REP), ensuring adherence to each country's specific regulatory frameworks.
Critical Tool for AML Management
AML is characterized as an aggressive and rapidly progressing hematologic malignancy where timely diagnosis and treatment are essential. The LeukoStrat CDx FLT3 Mutation Assay provides same-day results and precise identification of FLT3 mutations, which are associated with poor prognosis in AML patients.
FLT3 mutations occur in approximately 30% of AML cases and are considered important prognostic markers. Detection of these mutations helps clinicians identify patients who may benefit from targeted therapies, representing a crucial application of precision medicine in oncology.
"Making timely and accurate detection of actionable mutations such as FLT3 is critical and essential for optimizing patient outcomes," according to Invivoscribe's announcement. The assay's ability to provide standardized, reliable, and rapid FLT3 mutation testing plays a vital role in guiding therapeutic decisions.
Companion Diagnostic Applications
The LeukoStrat CDx FLT3 Mutation Assay serves as a companion diagnostic for multiple targeted therapies. In regions where XOSPATA (gilteritinib fumarate) is available, the assay helps identify AML patients who may benefit from this treatment. Similarly, in areas where VANFLYTA (quizartinib hydrochloride) is approved, the test aids in identifying FLT3-ITD+ AML patients suitable for this therapy.
The PCR-based in vitro diagnostic test is designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene. These genetic alterations are identified in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of AML patients.
Technical Specifications and Implementation
The LeukoStrat CDx FLT3 Mutation Assay is a qualitative, non-automated test designed for use on the 3500xL or 3500xL Dx Genetic Analyzers. Its technical design allows for integration into existing laboratory workflows at institutions treating AML patients.
Dr. Jeffrey Miller, CEO of Invivoscribe, emphasized the company's commitment to expanding access to high-quality, regulatory-compliant companion diagnostics. "This registration reinforces Invivoscribe's commitment to enabling clinicians and patients to benefit from cutting-edge advancements in molecular testing," he stated.
About Invivoscribe
Invivoscribe has established itself as a vertically integrated biotechnology company with nearly thirty years of experience in precision diagnostics. The company's mission centers on "Improving Lives with Precision Diagnostics®" through providing standardized reagents, tests, and bioinformatics tools.
The company maintains a global laboratory network with facilities in the United States, Germany, Japan, and China. Through its clinical lab subsidiaries (LabPMM), Invivoscribe offers both distributable diagnostic kits and clinical trial services, positioning itself as a comprehensive partner throughout the diagnostic development lifecycle—from initial development through clinical trials, regulatory submissions, and commercialization.
Expanding Global Access
The registration of the LeukoStrat CDx FLT3 Mutation Assay in the UK and Switzerland represents an important step in expanding global access to precision diagnostics for AML patients. As targeted therapies continue to reshape treatment paradigms for hematologic malignancies, companion diagnostics like the LeukoStrat assay play an increasingly vital role in ensuring patients receive the most appropriate and effective treatments.
Healthcare providers in these regions now have access to a standardized, regulatory-approved diagnostic tool that can help guide treatment decisions for AML patients, potentially improving outcomes for this challenging disease.
