LDT

Lab Community "Extremely Concerned" About Patient Access to Testing If FDA Regulates Lab-Developed Tests

Retrieved on: 
Tuesday, March 5, 2024
Marie Cassidy, Doctor of Philosophy, ARUP, MD, Synovial joint, Physician, FDA, ARUP Laboratories, Culture, 2005 in television, Manuscript, LDT, Feedback, Safety, Health, MedRxiv, Patient, Congress, Laboratory, Public, Medical device

"If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."

Key Points: 
  • "If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."
  • To better understand how clinical laboratorians perceive the proposed rule, ARUP Laboratories conducted a survey of the clinical laboratory community.
  • Most respondents identified themselves as lab managers, lab supervisors, lab directors, lab employees, medical directors, pathologists, physicians, clinicians, or PhD scientists.
  • Over a hundred thousand clinical laboratorians dedicate their professional lives to ensuring high-quality testing and patient care every day in the U.S.

CND Life Sciences Partners with Visiopharm on Novel AI-Tool to Detect and Quantify Pathological Alpha-Synuclein in Cutaneous Nerves

Retrieved on: 
Tuesday, March 5, 2024
Parkinson's disease, Marie Cassidy, Algorithm, Ariz, CND, MD, Pathology, Drug development, Alpha-synuclein, Neurology, LDT, Disease, Patient, Clinical trial, Sympathetic nervous system, Synucleinopathy, Diagnosis, Machine learning, Three-body problem, Deep learning, Lewy body, Partnership, Medical imaging

SCOTTSDALE, Ariz.., March 5, 2024 /PRNewswire/ -- CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today will unveil its NerValence pathology detection system at the AD/PD 2024 conference in Lisbon, Portugal. NerValence, developed through a strategic collaboration with precision pathology company Visiopharm, significantly enhances CND's biomarker testing services for clinical trials targeting the alpha-synuclein protein in patients with suspected Parkinson's disease, dementia with Lewy bodies, and related disorders.

Key Points: 
  • NerValence aids in the identification, tracking, and measuring the volume of alpha-synuclein in cutaneous nerves.
  • NerValence features machine learning algorithms that recognize and differentiate microscopic structures, nerves, and important disease markers that can be found in cutaneous tissue.
  • "Utilizing our novel deep learning technology to power this crucial advancement in neurodegenerative diseases represents a significant leap forward in analyzing peripheral nerves," said Michael Grunkin , Visiopharm Chief Executive Officer.
  • "Collaborating with CND Life Sciences on its deployment of NerValence will continue to be a major priority as we advance AI-driven precision pathology to enhance biopharmaceutical drug development."

DiaCarta Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024

Retrieved on: 
Monday, March 4, 2024
Recurrence, BCG, CMS, Physician, Bladder cancer, LDT, NMIBC, Medicare, Medicine, Patient, Diagnosis, CAP

PLEASANTON, Calif., March 4, 2024 /PRNewswire/ -- DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.

Key Points: 
  • PLEASANTON, Calif., March 4, 2024 /PRNewswire/ -- DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.
  • Oncuria-Monitor: Enables the monitoring of bladder cancer recurrence, offering physicians valuable insights for disease management and surveillance.
  • Oncuria-Predict: Revolutionizes the prediction of BCG therapy response for non-muscle invasive bladder cancer (NMIBC) patients, empowering clinicians with personalized treatment strategies.
  • By securing Medicare reimbursement for Oncuria®, DiaCarta continues to facilitate access to innovative diagnostic solutions for patients and healthcare providers nationwide.

Neurocode Launches Groundbreaking pTau217 Blood Test for Alzheimer's Disease Clinical Diagnosis

Retrieved on: 
Monday, March 4, 2024
Collection, Doctor of Philosophy, Research, MD, Blood, Pathology, Cerebrospinal fluid, Neurology, AUC, LDT, Laboratory developed test, Diagnosis, Simoa, Autopsy, Biomarker, Gold, Health, Patient, Radiation exposure, CSF, DSM-IV codes, Disease, PET, JAMA Neurology, Brain, Medical imaging

Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.

Key Points: 
  • Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.
  • Neurocode's new blood test is as accurate as brain imaging or CSF testing for diagnosing Alzheimer's, but is faster, more accessible, less expensive, and less invasive.
  • Neurocode is the first laboratory in the world to offer the ALZpath Dx test for clinical use within a CAP-accredited, CLIA-certified facility.
  • Sample collection kits are provided to facilitate blood collection and shipping to Neurocode by an affiliated phlebotomy site.

DiaCarta, Inc. and OncoAssure Ltd. Collaborate to Launch Prostate Cancer Lab Developed Test

Retrieved on: 
Monday, February 26, 2024
Cepheid variable, Recurrence, Prostate cancer, CMS, LDT, Laboratory developed test, Risk, Medicare, Patient, Infection, Prostate, Cancer, Partnership, Pharmaceutical industry

The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.

Key Points: 
  • The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.
  • This partnership will expedite the validation process and pave the way for commercialization of the OncoAssure Prostate LDT test, benefiting healthcare providers and patients alike."
  • Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta, added, "We are very pleased to collaborate with OncoAssure to bring the best-in-class highly accurate OncoAssure Prostate LDT test to commercialization in DiaCarta's CAP/CLIA laboratory.
  • The unique OncoAssure Prostate prognostic test addresses an unmet need in prostate cancer management and is a valued addition to DiaCarta's portfolio of molecular diagnostic tests for cancer that includes tests for bladder and colorectal cancer."

Tempus Introduces xM to Assess Minimal Residual Disease (MRD) in Patients with Colorectal Cancer (CRC) for Research Use Only

Retrieved on: 
Thursday, January 18, 2024
Technology, Research, Surgery, Medical Devices, Health Technology, Health, Science, Artificial Intelligence, Oncology, Clonal hematopoiesis, Patient, MRD, Neoplasm, DNA, CHIP, Liquid biopsy, DX, Intelligence, Chief Justice of Hungary, Algorithm, Lung cancer, Risk, Methylation, Recurrence, Plasma, NeXT, LDT, Doctor of Philosophy, Artifact, CRC, Medicine, Blood, Medical imaging

Tempus, a leader in artificial intelligence and precision medicine, today announced the addition of a novel MRD assay, xM, to its comprehensive testing solutions.

Key Points: 
  • Tempus, a leader in artificial intelligence and precision medicine, today announced the addition of a novel MRD assay, xM, to its comprehensive testing solutions.
  • The tumor-naïve plasma based test is available for research use only to detect circulating tumor DNA (ctDNA) in the blood of patients with early stage CRC after surgery.
  • xM is a liquid biopsy approach to MRD assessment, where no baseline tumor tissue is required.
  • “Colorectal cancer is the second leading cause of cancer-related deaths worldwide,1 and surgical intervention alone may not be curative for all patients.

Bionano Reports Preliminary Fourth Quarter and Full-Year 2023 Results

Retrieved on: 
Monday, January 8, 2024
NGS, LCD, OGM, Sale, Met, Workflow, FDA, Data analysis, DNA, Doctor of Philosophy, IRB, SAN, Bank statement, ATM, Genomics, LDT, Medicare, Data collection, Bone marrow, Video game

The Company’s full results for the fourth quarter and the fiscal year ended December 31, 2023 are not yet available.

Key Points: 
  • The Company’s full results for the fourth quarter and the fiscal year ended December 31, 2023 are not yet available.
  • Nanochannel array flowcells sold in the fourth quarter is expected to be 7,980, an estimated increase of 67% over the 4,781 flowcells sold in the fourth quarter of 2022.
  • Bionano has not completed preparation of its financial statements for the fourth quarter or full year of 2023.
  • Additional information and disclosures would be required for a more complete understanding of Bionano’s financial position and results of operations as of and for the fourth quarter and year ended December 31, 2023.

International Consortium Publishes Comprehensive Roadmap for the Clinical Implementation of OGM in Hematological Malignancy Applications

Retrieved on: 
Wednesday, January 3, 2024
Consortium, OGM, SVS, Radboud University Medical Center, Workflow, University, Bone marrow, Quality control, Blood, University of Oulu, SAN, Columbia University, Laboratory, LDT, UZ Leuven, MD Anderson Cancer Center, Biomarker, University of Toronto, University Health Network, Algorithm, Medical device

The authors believe that a proactive approach to the development of standards would be beneficial for global laboratories’ understanding of how best to use an OGM workflow.

Key Points: 
  • The authors believe that a proactive approach to the development of standards would be beneficial for global laboratories’ understanding of how best to use an OGM workflow.
  • Consortium members collaboratively outlined a consensus framework designed to provide guidance to laboratories interested in the adoption and implementation of OGM.
  • The authors covered considerations that need to be addressed when incorporating OGM into a laboratory, including assessment of clinical utility, proof of principle study, method validation, clinical validation, and implementation.
  • The framework addresses these considerations with specific recommendations in three areas: validation, quality control, and analysis and interpretation of variants.

Blue Water Biotech Acquires Proteomedix as Part of Transformation to Commercial Stage Oncology Company; Announces Name Change to Onconetix™

Retrieved on: 
Monday, December 18, 2023
Physician, Research, FDA, Acquisition, Transaction, Prostate cancer, Cancer, BWB, LDT, Patient, BPH, Therapy, Management

The acquisition of Proteomedix for all stock consideration provides its shareholders with an initial 19.9% ownership stake of Onconetix.

Key Points: 
  • The acquisition of Proteomedix for all stock consideration provides its shareholders with an initial 19.9% ownership stake of Onconetix.
  • Two members of Proteomedix’ leadership team will become executives of Onconetix.
  • “This pivotal move not only expands our global footprint, it enables us to harness the advanced technological platform and diagnostic expertise of Proteomedix.
  • Tungsten Advisors served as the exclusive financial advisor to Proteomedix AG.

Bionano Laboratories Announces Publication of the Analytical Validation of its OGM-Based Laboratory Developed Test for Hematological Malignancies and Additional Multi-Site Technical Evaluation of OGM

Retrieved on: 
Tuesday, December 12, 2023
CMA, OGM, SVS, Bone marrow, Workflow, WHO, NCCN, Blood, SAN, IRB, Laboratory, University, LDT, Aberration, VAF, World Health Organization, Genome, National Comprehensive Cancer Network, Chromosomal translocation, Tier 1, KT, Diagnosis, Patient, Malignancy, Tier 2

SAN DIEGO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Bionano Laboratories today announced the publication of a study covering the analytical validation of its laboratory developed test (LDT), marketed as OGM-Dx™ HemeOne.

Key Points: 
  • SAN DIEGO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Bionano Laboratories today announced the publication of a study covering the analytical validation of its laboratory developed test (LDT), marketed as OGM-Dx™ HemeOne.
  • The publication also included a multi-site peer-reviewed IRB-approved analytical validation study of OGM for the analysis of hematological malignancy samples, conducted by researchers at laboratories including Bionano Laboratories, Augusta University, University of Rochester Medical Center, and Children’s Hospital Los Angeles.
  • Subsequently, the OGM workflow was applied at the other three sites, showing high levels of reproducibility across the sites.
  • “We are pleased to see the clinical validation of Bionano Laboratories' OGM-Dx™ HemeOne LDT, analyzing its potential to serve as a first-tier cytogenetic test for heme malignancies.