Latest news with #Invivoscribe
National Post
3 days ago
- Health
- National Post
LabPMM® Receives New York State Approval for the NPM1 MRD Assay - Informing Therapy and Accelerating Targeted Trials
Article content SAN DIEGO — Invivoscribe is happy to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine ® (LabPMM) has received approval from New York State (NYS) for the NPM1 MRD Assay. This approval comes just two months after gaining NYS approval for our FLT3 ITD MRD Assay. Together these tests represent a critical tool for patients with acute myeloid leukemia (AML), clinicians and pharmaceutical companies. This new approval underscores Invivoscribe's ongoing commitment to providing the most accurate, standardized measurable residual disease (MRD) testing solutions worldwide. Article content The NPM1 MRD Assay is a pivotal development in the fight against AML, offering an ultra-sensitive DNA sequencing method to accurately measure trace levels of residual leukemia cells in patients with the NPM1 mutation variants. NPM1 mutations are considered an ideal target for MRD assessment because they are present in ~30% of adult AML cases, 1 stable over time, 2 and, if present in blood at allele fractions ≥0.01%, are associated with increased relapse and worse overall survival. 3 Recent studies show emerging evidence that pre-transplant MRD testing for NPM1 and FLT3 -ITD identifies AML patients in remission who are most likely to relapse or experience poor survival. 3,4,5 With this approval, LabPMM is helping to transform the landscape of AML research, treatment and drug development. By using MRD as a surrogate endpoint in clinical trials, instead of relying solely on overall survival (OS), pharmaceutical companies can accelerate their drug development timelines. This is particularly valuable in acute disease, where time is of the essence, and earlier intervention can dramatically improve patient outcomes. Article content 'We are proud to receive New York State approval for our NPM1 MRD Assay by NGS, marking our second assay approved by New York State this year,' said Jordan Thornes, V.P., Global Clinical Laboratory Operations at LabPMM. 'This milestone reflects our continued dedication to advancing precision diagnostics in cancer care. With this latest approval, we're further empowering clinicians with sensitive, reliable tools to detect residual disease and guide treatment decisions with confidence.' Article content LabPMM's NPM1 and FLT3 ITD MRD Assays are standardized next generation sequencing (NGS) tests that complement the LeukoStrat ® CDx FLT3 Mutation Assay, which is used to guide treatment selection for patients with AML. These services are offered in the U.S., European Union, and across Asia to ensure patients around the world have access to high-quality, standardized testing and to support the development of cutting-edge cancer treatments. LabPMM remains committed to advancing precision medicine and improving outcomes for patients worldwide. For more information about the NPM1 MRD Assay and LabPMM's full test menu, please visit or contact us at inquiry@ and follow us on LinkedIn. Article content About Invivoscribe Article content 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 U.S., 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. Article content Article content Article content Article content Article content Article content
Yahoo
3 days ago
- Business
- Yahoo
LabPMM® Receives New York State Approval for the NPM1 MRD Assay - Informing Therapy and Accelerating Targeted Trials
SAN DIEGO, June 18, 2025--(BUSINESS WIRE)--Invivoscribe is happy to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine® (LabPMM) has received approval from New York State (NYS) for the NPM1 MRD Assay. This approval comes just two months after gaining NYS approval for our FLT3 ITD MRD Assay. Together these tests represent a critical tool for patients with acute myeloid leukemia (AML), clinicians and pharmaceutical companies. This new approval underscores Invivoscribe's ongoing commitment to providing the most accurate, standardized measurable residual disease (MRD) testing solutions worldwide. The NPM1 MRD Assay is a pivotal development in the fight against AML, offering an ultra-sensitive DNA sequencing method to accurately measure trace levels of residual leukemia cells in patients with the NPM1 mutation variants. NPM1 mutations are considered an ideal target for MRD assessment because they are present in ~30% of adult AML cases,1 stable over time,2 and, if present in blood at allele fractions ≥0.01%, are associated with increased relapse and worse overall survival.3 Recent studies show emerging evidence that pre-transplant MRD testing for NPM1 and FLT3-ITD identifies AML patients in remission who are most likely to relapse or experience poor survival.3,4,5 With this approval, LabPMM is helping to transform the landscape of AML research, treatment and drug development. By using MRD as a surrogate endpoint in clinical trials, instead of relying solely on overall survival (OS), pharmaceutical companies can accelerate their drug development timelines. This is particularly valuable in acute disease, where time is of the essence, and earlier intervention can dramatically improve patient outcomes. "We are proud to receive New York State approval for our NPM1 MRD Assay by NGS, marking our second assay approved by New York State this year," said Jordan Thornes, V.P., Global Clinical Laboratory Operations at LabPMM. "This milestone reflects our continued dedication to advancing precision diagnostics in cancer care. With this latest approval, we're further empowering clinicians with sensitive, reliable tools to detect residual disease and guide treatment decisions with confidence." LabPMM's NPM1 and FLT3 ITD MRD Assays are standardized next generation sequencing (NGS) tests that complement the LeukoStrat® CDx FLT3 Mutation Assay, which is used to guide treatment selection for patients with AML. These services are offered in the U.S., European Union, and across Asia to ensure patients around the world have access to high-quality, standardized testing and to support the development of cutting-edge cancer treatments. LabPMM remains committed to advancing precision medicine and improving outcomes for patients worldwide. For more information about the NPM1 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 U.S., 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. Falini, B. et al. Blood. 2020; 136(15):1707–1721. Kelemen, K. Life. 2022; 12(1): 109. Dillon, L. et al. JAMA. 2023; 329(9):745-755 Dillon, L. et al. JAMA Oncology. 2024; 10(8)1104-1110 Levis, M. et al. Blood. 2025; 145(19):2138-2148. View source version on Contacts inquiry@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
3 days ago
- Business
- Business Wire
LabPMM ® Receives New York State Approval for the NPM1 MRD Assay - Informing Therapy and Accelerating Targeted Trials
SAN DIEGO--(BUSINESS WIRE)--Invivoscribe is happy to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine ® (LabPMM) has received approval from New York State (NYS) for the NPM1 MRD Assay. This approval comes just two months after gaining NYS approval for our FLT3 ITD MRD Assay. Together these tests represent a critical tool for patients with acute myeloid leukemia (AML), clinicians and pharmaceutical companies. This new approval underscores Invivoscribe's ongoing commitment to providing the most accurate, standardized measurable residual disease (MRD) testing solutions worldwide. The NPM1 MRD Assay is a pivotal development in the fight against AML, offering an ultra-sensitive DNA sequencing method to accurately measure trace levels of residual leukemia cells in patients with the NPM1 mutation variants. NPM1 mutations are considered an ideal target for MRD assessment because they are present in ~30% of adult AML cases, 1 stable over time, 2 and, if present in blood at allele fractions ≥0.01%, are associated with increased relapse and worse overall survival. 3 Recent studies show emerging evidence that pre-transplant MRD testing for NPM1 and FLT3 -ITD identifies AML patients in remission who are most likely to relapse or experience poor survival. 3,4,5 With this approval, LabPMM is helping to transform the landscape of AML research, treatment and drug development. By using MRD as a surrogate endpoint in clinical trials, instead of relying solely on overall survival (OS), pharmaceutical companies can accelerate their drug development timelines. This is particularly valuable in acute disease, where time is of the essence, and earlier intervention can dramatically improve patient outcomes. 'We are proud to receive New York State approval for our NPM1 MRD Assay by NGS, marking our second assay approved by New York State this year,' said Jordan Thornes, V.P., Global Clinical Laboratory Operations at LabPMM. 'This milestone reflects our continued dedication to advancing precision diagnostics in cancer care. With this latest approval, we're further empowering clinicians with sensitive, reliable tools to detect residual disease and guide treatment decisions with confidence.' LabPMM's NPM1 and FLT3 ITD MRD Assays are standardized next generation sequencing (NGS) tests that complement the LeukoStrat ® CDx FLT3 Mutation Assay, which is used to guide treatment selection for patients with AML. These services are offered in the U.S., European Union, and across Asia to ensure patients around the world have access to high-quality, standardized testing and to support the development of cutting-edge cancer treatments. LabPMM remains committed to advancing precision medicine and improving outcomes for patients worldwide. For more information about the NPM1 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 U.S., 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.
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
