Latest news with #ClinicalLaboratoryEvaluationProgram
Business Wire
22-04-2025
- Health
- Business Wire
Invivoscribe's LabPMM Gains New York State Approval for the FLT3 ITD MRD Assay
SAN DIEGO--(BUSINESS WIRE)--Invivoscribe is proud to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine ® (LabPMM), LLC has received approval from the New York State Department of Health to offer the FLT3 ITD MRD Assay to assess measurable residual disease (MRD). LabPMM's ultra-sensitive next generation sequencing FLT3 ITD MRD Assay provides clinicians with critical insights to tailor acute myeloid leukemia (AML) treatments and improve patient outcomes. Following a rigorous review by the Clinical Laboratory Evaluation Program (CLEP), the Department of Health has determined that LabPMM meets the required standards and granted approval to offer the FLT3 ITD MRD Assay in New York State. This approval underscores the assay's robust analytical performance and clinical utility in the detection of MRD in patients with FLT3 ITD-mutated AML. "This milestone reflects our commitment to improve patient lives with precision diagnostics," said Jordan Thornes, V.P. 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." The FLT3 ITD MRD assay is a targeted, highly sensitive next-generation sequencing (NGS) assay that detects and tracks internal tandem duplication (ITD) mutations in the fms-like tyrosine kinase 3 (FLT3) gene at an allele sensitivity of 5 x 10 -5. FLT3 ITD mutations are the most prevalent mutations found in AML and are characterized by an aggressive phenotype with a high prevalence of relapse. 1,2 Detection of residual FLT3 ITD allows clinicians to identify patients that can benefit from continuation or modification of treatment and predict clinical outcomes. 1,2,3 For more information about the FLT3 ITD MRD Assay and LabPMM's full test menu, please visit or contact us at inquiry@ and follow us on LinkedIn. About Invivoscribe Invivoscribe ® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics ®. For thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the US, Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM ®), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization. Dillon, L., et al. JAMA. 2023;329(9):745-755. Dillon, L., et al. JAMA Oncol. 2024;10(8):1104-1110. Levis, MJ et al. (2018) Blood Advances. 2: 825-831.
Yahoo
22-04-2025
- Business
- Yahoo
Invivoscribe's LabPMM Gains New York State Approval for the FLT3 ITD MRD Assay
SAN DIEGO, April 22, 2025--(BUSINESS WIRE)--Invivoscribe is proud to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine® (LabPMM), LLC has received approval from the New York State Department of Health to offer the FLT3 ITD MRD Assay to assess measurable residual disease (MRD). LabPMM's ultra-sensitive next generation sequencing FLT3 ITD MRD Assay provides clinicians with critical insights to tailor acute myeloid leukemia (AML) treatments and improve patient outcomes. Following a rigorous review by the Clinical Laboratory Evaluation Program (CLEP), the Department of Health has determined that LabPMM meets the required standards and granted approval to offer the FLT3 ITD MRD Assay in New York State. This approval underscores the assay's robust analytical performance and clinical utility in the detection of MRD in patients with FLT3 ITD-mutated AML. "This milestone reflects our commitment to improve patient lives with precision diagnostics," said Jordan Thornes, V.P. 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." The FLT3 ITD MRD assay is a targeted, highly sensitive next-generation sequencing (NGS) assay that detects and tracks internal tandem duplication (ITD) mutations in the fms-like tyrosine kinase 3 (FLT3) gene at an allele sensitivity of 5 x 10-5. FLT3 ITD mutations are the most prevalent mutations found in AML and are characterized by an aggressive phenotype with a high prevalence of relapse. 1,2 Detection of residual FLT3 ITD allows clinicians to identify patients that can benefit from continuation or modification of treatment and predict clinical outcomes. 1,2,3 For more information about the FLT3 ITD MRD Assay and LabPMM's full test menu, please visit or contact us at inquiry@ and follow us on LinkedIn. About Invivoscribe Invivoscribe® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the US, Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM®), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization. Dillon, L., et al. JAMA. 2023;329(9):745-755. Dillon, L., et al. JAMA Oncol. 2024;10(8):1104-1110. Levis, MJ et al. (2018) Blood Advances. 2: 825-831. View source version on Contacts inquiry@ Sign in to access your portfolio
Yahoo
18-02-2025
- Health
- Yahoo
ClearNote Health Earns Approval for Avantect® Pancreatic Cancer Test from New York State Department of Health
Physicians in New York can now order the highly sensitive blood test designed to detect pancreatic cancer far earlier than conventional approaches SAN DIEGO, February 18, 2025--(BUSINESS WIRE)--ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) has approved its Avantect® Pancreatic Cancer Test. With this approval, clinicians in New York State can now order this highly sensitive blood test, which is designed to detect the biological signals of pancreatic cancer in its earliest stages for patients with known risk factors. "New York State is well known for its rigorous, patient-focused quality standards for laboratory-developed tests. This approval is another critical milestone for ClearNote Health, further validating our ongoing commitment to excellence in our tests and in our clinical laboratory services," said Dave Mullarkey, CEO at ClearNote Health. "We are quickly transforming the patient care paradigm with a proprietary, epigenomics-based approach that allows clinicians to detect pancreatic cancer at a more treatable stage so patients can enjoy longer, healthier lives." While early detection has vastly improved survival rates for other types of cancer, pancreatic cancer is often diagnosed at an advanced metastatic stage when patients have a five-year survival rate as low as 3%.1 The Avantect Pancreatic Cancer Test is for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a family history and/or a genetic predisposition. The test was designed to detect pancreatic cancer in its earliest stages by profiling the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA and combining that data with other genomic information. Unlike conventional methods, ClearNote's approach leverages the latest advances in machine learning and bioinformatics to provide a deeper understanding of the underpinnings of cancer development with unprecedented clarity to inform the next steps in a patient care pathway. For more information about the Avantect Pancreatic Cancer Test, please visit The NYSDOH CLEP regulates and oversees laboratories that accept clinical specimens originating in New York State. It seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from New York State. The ClearNote Health Laboratory now has its NYSDOH permit, as well as its CLIA certification and CAP accreditation. About ClearNote Health ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company's patented core Virtuoso® epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company's highly sensitive, noninvasive Avantect® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health's headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit or follow the company on X or LinkedIn. ClearNote Health, the ClearNote Health logo, Avantect, and Virtuoso are registered trademarks of ClearNote Health. References 1. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. View source version on Contacts Media Contact Andrew Noble415-722-2129andrew@ Sign in to access your portfolio
