Invivoscribe announced today that its subsidiary, Laboratory for Personalized Molecular Medicine (LabPMM), has received approval from the New York State Department of Health to offer its FLT3 ITD MRD Assay for assessing measurable residual disease (MRD) in acute myeloid leukemia (AML) patients. This ultra-sensitive next-generation sequencing test provides critical insights that allow clinicians to personalize treatment approaches and potentially improve outcomes for patients with this aggressive form of leukemia.
The approval follows a comprehensive evaluation by the state's Clinical Laboratory Evaluation Program (CLEP), confirming that the assay meets New York's stringent regulatory standards. This validation enables immediate access to the test for clinicians and patients throughout New York, one of the nation's largest and most rigorously regulated laboratory testing markets.
"This milestone reflects our commitment to improve patient lives with precision diagnostics," said Jordan Thornes, Vice President of Global Clinical Operations at LabPMM. "With New York state's approval, we are immediately able to extend access to this important test to clinicians and patients throughout one of the nation's largest and most rigorously regulated laboratory testing markets."
Technical Specifications and Clinical Significance
The FLT3 ITD MRD assay employs targeted next-generation sequencing technology to detect and monitor internal tandem duplication (ITD) mutations in the fms-like tyrosine kinase 3 (FLT3) gene. The test achieves an exceptional allele sensitivity of 5 x 10^-5, allowing for the detection of minimal residual disease at levels far below the threshold of conventional testing methods.
FLT3 ITD mutations represent the most common genetic alterations in AML, occurring in approximately 25-30% of patients. These mutations are associated with an aggressive disease phenotype and significantly higher relapse rates compared to FLT3 wild-type AML. Recent studies published in JAMA (2023) and JAMA Oncology (2024) have demonstrated that persistent FLT3 ITD mutations after therapy correlate strongly with adverse outcomes.
The ability to detect residual FLT3 ITD mutations at ultra-low levels provides clinicians with actionable information to:
- Identify patients who may benefit from continuation of targeted therapy
- Guide decisions regarding treatment modification or intensification
- Predict clinical outcomes with greater accuracy
- Monitor treatment response in real-time
Implications for AML Management
AML represents one of the most challenging hematologic malignancies, with a five-year survival rate of approximately 29% across all age groups. For patients with FLT3 ITD mutations, outcomes have historically been even poorer, though the introduction of FLT3 inhibitors has improved the therapeutic landscape.
The availability of highly sensitive MRD testing addresses a critical unmet need in AML management. Traditional morphologic assessment of remission (defined as <5% blasts in bone marrow) fails to detect lower levels of residual disease that can lead to relapse. The FLT3 ITD MRD Assay can detect one mutant cell among 20,000 normal cells, providing a much more accurate assessment of treatment efficacy.
Dr. Mark Levis, a leading AML researcher not affiliated with Invivoscribe, noted in a 2018 Blood Advances publication that "MRD monitoring in FLT3-mutated AML represents a powerful tool for predicting relapse and guiding therapeutic decisions."
About Invivoscribe and LabPMM
Invivoscribe is a global biotechnology company with a 30-year history in precision diagnostics. The company's vertically integrated approach encompasses reagent development, test creation, bioinformatics tools, and laboratory services. LabPMM, its wholly-owned subsidiary, operates clinical laboratories in the United States, Germany, Japan, and China.
The company has established a successful track record of partnerships with pharmaceutical companies for clinical trial testing and companion diagnostic development. This comprehensive approach positions Invivoscribe as a key player in advancing precision medicine in oncology.
The FLT3 ITD MRD Assay joins LabPMM's extensive menu of molecular diagnostic tests focused on hematologic malignancies. For clinicians treating AML patients in New York State, this newly approved test represents an important addition to the diagnostic arsenal in the fight against this challenging disease.
