Approval of LeukoStrat CDx FLT3 Mutation Assay in the EU
Invivoscribe has made a significant announcement regarding its CE-2797 IVD certified LeukoStrat CDx FLT3 Mutation Assay. This diagnostic test has received approval from BSI Netherlands and the EMA, a pivotal step that will aid in selecting patients in the European Union and European Economic Area diagnosed with FLT3-ITD positive acute myeloid leukemia (AML) who are eligible for treatment with Daiichi Sankyo's VANFLYTA (quizartinib). As a Notified Body accredited in the EU, BSI's certification ensures that the assay complies with rigorous European regulations.
Importance of Targeting FLT3 Mutations
Invivoscribe is dedicated to advancing diagnostic tools that lead to personalized treatment solutions, ultimately improving the lives of individuals affected by aggressive forms of leukemia. Jason Gerhold, the Vice President of Global Regulatory, Quality and Clinical Affairs at Invivoscribe, emphasized the importance of targeting driver mutations linked to innovative therapies like VANFLYTA. He stated, "This Class C CDx assay provides oncologists with an essential tool to optimize treatment options for their patients."
Understanding Acute Myeloid Leukemia (AML)
Acute myeloid leukemia is a serious blood cancer characterized by the rapid multiplication of abnormal white blood cells. It is known for having one of the lowest survival rates among all leukemias, with about 31.9% surviving five years post-diagnosis. Approximately 25% of AML patients possess the FLT3-ITD mutation, a significant factor contributing to the growth and persistence of cancer cells.
How the LeukoStrat CDx FLT3 Mutation Assay Works
This in vitro diagnostic test employs a PCR-based method to detect specific mutations in the FLT3 gene, including internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations such as D835 and I836. The assay utilizes genomic DNA extracted from mononuclear cells found in peripheral blood or bone marrow aspirates of AML patients.
Therapeutic Use Cases of the Assay
The LeukoStrat CDx FLT3 Mutation Assay serves as a companion diagnostic for two notable treatments. When XOSPATA (gilteritinib fumarate) is available, this test aids healthcare providers in assessing AML patients who may qualify for this therapy. In situations where VANFLYTA (quizartinib hydrochloride) is an option, the assay assists in identifying patients with FLT3-ITD+ AML who might benefit from this specific treatment protocol.
Characteristics of the Test
This qualitative, non-automated diagnostic test is designed for usage on the 3500xL or 3500xL Dx Genetic Analyzers, allowing for reliable results that can guide treatment choices.
About Invivoscribe
Invivoscribe is a pioneering biotechnology firm passionate about precision medicine, with a mission to enhance healthcare quality globally through its advanced diagnostic tools. For almost thirty years, it has provided high-quality reagents, tests, and bioinformatics that drive breakthroughs in personalized medicine. Invivoscribe's established collaborations with leading pharmaceutical companies reflect its extensive expertise in diagnostic development and regulatory processes, ensuring that companion diagnostics reach the market effectively.
For more information, you can visit their official website or get in touch through their contact options. You can also follow their updates on LinkedIn to stay informed about their latest innovations and developments.
Frequently Asked Questions
What is the LeukoStrat CDx FLT3 Mutation Assay?
The LeukoStrat CDx FLT3 Mutation Assay is an in vitro diagnostic test that detects mutations in the FLT3 gene, aiding in the treatment selection for AML patients.
Who approved the LeukoStrat CDx FLT3 Mutation Assay?
The assay received approval from BSI Netherlands and the European Medicines Agency (EMA).
What is its significance in AML treatment?
The assay helps identify patients who are eligible for targeted therapies such as VANFLYTA, which is crucial for improving treatment outcomes in AML.
Which mutations does the assay detect?
It detects internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations in the FLT3 gene.
How long has Invivoscribe been in the biotechnology industry?
Invivoscribe has been advancing precision diagnostics for nearly thirty years, developing tools and tests that enhance healthcare worldwide.
