Invivoscribe Registers LeukoStrat® CDx FLT3 Assay in UK & Switzerland
Invivoscribe, a global leader in precision diagnostics, has announced the successful registration of its LeukoStrat CDx FLT3 Mutation Assay in both the United Kingdom (UK) and Switzerland. This critical milestone significantly expands access to high-quality molecular diagnostics, ensuring that clinicians and patients benefit from advanced leukemia detection tools in these regions.
Enhancing Access to Precision Medicine
The LeukoStrat CDx FLT3 Mutation Assay is a companion diagnostic designed to aid in the detection of FLT3 mutations, which play a crucial role in the prognosis and treatment of acute myeloid leukemia (AML). AML is an aggressive hematologic malignancy, and timely identification of FLT3 mutations is essential for guiding targeted therapies. By offering rapid and reliable results, the assay empowers clinicians to make well-informed treatment decisions, ultimately improving patient outcomes.
The approval and listing of the assay in the UK and Switzerland were made possible through Invivoscribe’s UK Responsible Person (UKRP) and Swiss Authorized Representative (CH-REP). These entities ensured full compliance with regulatory requirements set forth by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and Swissmedic in Switzerland. Both agencies are responsible for assessing product safety, efficacy, and post-market surveillance, ensuring that all diagnostics meet stringent national standards.
The Role of FLT3 Mutations in AML
FLT3 mutations are among the most common genetic abnormalities observed in AML patients, with internal tandem duplications (FLT3-ITD) and tyrosine kinase domain (TKD) mutations being associated with poor prognosis and disease progression. The presence of these mutations can significantly influence treatment strategies, making it imperative for healthcare providers to have access to highly precise diagnostic tools.
The LeukoStrat CDx FLT3 Mutation Assay offers a standardized and reliable method for identifying these mutations. The assay utilizes polymerase chain reaction (PCR)-based testing to detect FLT3-ITD and TKD mutations (D835 and I836) in genomic DNA extracted from peripheral blood or bone marrow samples. With its high sensitivity and specificity, the test provides rapid, same-day results that support precision medicine initiatives.
Meeting Global Regulatory Standards
The registration of the LeukoStrat CDx FLT3 Mutation Assay in the UK and Switzerland aligns with Invivoscribe’s broader mission to expand access to high-quality companion diagnostics worldwide. Regulatory compliance is a cornerstone of this strategy, ensuring that all assays meet the highest international standards for accuracy and reliability.
The MHRA and Swissmedic registrations follow previous approvals in other global markets, further reinforcing the assay’s clinical value. Invivoscribe remains committed to working closely with regulatory authorities to facilitate market access and support the implementation of precision diagnostics in oncology care.
Companion Diagnostic for Targeted Therapies
As a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay plays a critical role in guiding treatment decisions for AML patients. The test is used to determine eligibility for targeted FLT3 inhibitor therapies, including:
- XOSPATA® (gilteritinib fumarate) – This targeted therapy is designed for AML patients with FLT3 mutations. The LeukoStrat CDx FLT3 Mutation Assay aids in identifying patients who may benefit from XOSPATA® treatment, ensuring personalized care approaches.
- VANFLYTA® (quizartinib hydrochloride) – Used for patients with FLT3-ITD-positive AML, VANFLYTA® is another critical therapeutic option. The assay helps assess mutation status, aiding clinicians in determining the most appropriate treatment regimen.
By facilitating personalized treatment pathways, the LeukoStrat CDx FLT3 Mutation Assay directly contributes to improving the prognosis and quality of life for AML patients.
The Growing Need for Molecular Diagnostics in Hematology
The field of hematologic oncology has witnessed remarkable advancements in molecular diagnostics over the past decade. As new targeted therapies continue to emerge, the demand for precise and efficient companion diagnostics has grown exponentially. The ability to detect actionable mutations such as FLT3 not only improves treatment selection but also enhances patient monitoring and disease management.
Invivoscribe’s commitment to precision medicine is reflected in its extensive portfolio of diagnostic solutions. The company has been at the forefront of developing and commercializing molecular assays that support hematologic malignancies, enabling clinicians to adopt a more tailored approach to cancer treatment.
Future Implications and Global Expansion
The successful registration of the LeukoStrat CDx FLT3 Mutation Assay in the UK and Switzerland marks an important step in Invivoscribe’s ongoing expansion. By securing approvals in key international markets, the company is poised to further enhance global access to state-of-the-art molecular diagnostics.
Looking ahead, Invivoscribe aims to continue expanding its reach by:
- Collaborating with healthcare institutions to integrate FLT3 testing into routine clinical practice.
- Pursuing additional regulatory approvals in other countries to broaden patient access.
- Advancing research in molecular diagnostics to develop next-generation assays for hematologic malignancies.
