Laboratory developed test

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

Retrieved on: 
Monday, March 4, 2024

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

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."

Enable Biosciences Publishes Study Revealing ADAP Technology's Improved Accuracy in T1D Risk Prediction

Retrieved on: 
Tuesday, February 13, 2024

Detailed findings are presented in the article "Advances in risk predictive performance of pre-symptomatic type 1 diabetes via the multiplex Antibody-Detection-by-Agglutination-PCR (ADAP) assay," published in Frontiers of Endocrinology.

Key Points: 
  • Detailed findings are presented in the article "Advances in risk predictive performance of pre-symptomatic type 1 diabetes via the multiplex Antibody-Detection-by-Agglutination-PCR (ADAP) assay," published in Frontiers of Endocrinology.
  • This pivotal study underscores the ADAP assay's ability to detect islet autoantibodies, which are indicative of a high risk of progression to clinical T1D.
  • Dr. Jason Tsai, PhD, CTO of Enable Biosciences, elaborates on the significance of the findings: "These study results reinforce the strength of our ADAP technology in early T1D detection.
  • For more insights into Enable Biosciences and the impact of their ADAP technology, please visit www.enablebiosciences.com .

Quanterix Announces New Agreement to Advance Blood Based Alzheimer's Disease Detection

Retrieved on: 
Tuesday, October 24, 2023

Under this agreement, Quanterix will receive worldwide, non-exclusive rights to J&J’s extensively studied p-Tau 217 antibodies and assay designs for potential use in clinical research and diagnostic products, further strengthening Quanterix’s position at the forefront of the Alzheimer's Disease (AD) biomarker field.

Key Points: 
  • Under this agreement, Quanterix will receive worldwide, non-exclusive rights to J&J’s extensively studied p-Tau 217 antibodies and assay designs for potential use in clinical research and diagnostic products, further strengthening Quanterix’s position at the forefront of the Alzheimer's Disease (AD) biomarker field.
  • Under the terms of the license agreement, Janssen will grant Quanterix a worldwide non-exclusive license for J&J-developed technology to produce Simoa p-Tau 217 research-use only (RUO) assay kits for global distribution.
  • Furthermore, under the agreement Quanterix will launch a Laboratory Developed Test (LDT) based on the J&J p-Tau 217 antibodies and assay, offered through Accelerator under the Lucent Diagnostics brand.
  • "This collaboration demonstrates the scientific advances that are possible when Simoa’s ultra-sensitive detection is combined with clinically validated antibodies and critical reagents,” said Masoud Toloue, CEO of Quanterix.

Oxford BioDynamics Receives Reimbursement Code for EpiSwitch® Prostate Screening (PSE) Test

Retrieved on: 
Tuesday, October 3, 2023

The unique code, 0433U, was issued to Oxford BioDynamics for the 94% accurate EpiSwitch® Prostate Screening (PSE) test.

Key Points: 
  • The unique code, 0433U, was issued to Oxford BioDynamics for the 94% accurate EpiSwitch® Prostate Screening (PSE) test.
  • The code was published on 29 September and payors will be able to bill for the test using the code from 1 January 2024.
  • A miscellaneous code for high complexity molecular testing will be used for reimbursement until the unique code goes live.
  • The new CPT code provides a standardized billing mechanism for the PSE Test across all US healthcare providers, ensuring accurate reimbursement.

On World Alzheimer’s Day, C2N Diagnostics’ PrecivityAD2™ Blood Test Expands Reach

Retrieved on: 
Thursday, September 21, 2023

Building on the success of the PrecivityAD2 blood test launch in the United States this summer, C₂N’s making the test available in Brazil through its partnership with Grupo Fleury , one of that country’s leading healthcare companies.

Key Points: 
  • Building on the success of the PrecivityAD2 blood test launch in the United States this summer, C₂N’s making the test available in Brazil through its partnership with Grupo Fleury , one of that country’s leading healthcare companies.
  • Healthcare providers in Brazil can order the test through their existing ties to Grupo Fleury.
  • Dr. Aurélio Pimenta Dutra, Fleury’s medical advisor for neurology, says, “I’m glad we’re able to offer the PrecivityAD2 blood test from C2N Diagnostics, which has really set itself apart as a leader in this sector.
  • The PrecivityAD2 blood test is helping healthcare providers determine the presence or absence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease.

C2N Diagnostics Releases the PrecivityAD2™ Blood Test for Clinical Care, a Robust Assay with High Concordance to Amyloid PET and CSF

Retrieved on: 
Thursday, August 17, 2023

C2N Diagnostics , a leader in advanced brain health diagnostics, today announced the release of the PrecivityAD2 blood test , a clinical care assay that meets the standard of care with currently available PET scans and cerebrospinal fluid tests.

Key Points: 
  • C2N Diagnostics , a leader in advanced brain health diagnostics, today announced the release of the PrecivityAD2 blood test , a clinical care assay that meets the standard of care with currently available PET scans and cerebrospinal fluid tests.
  • In a clinical validation study involving two independent cohorts totaling 583 patients with cognitive impairment using amyloid PET as the reference standard, the PrecivityAD2 blood test achieved an overall test performance statistic of 0.94 AUC and 88% accuracy.
  • The PrecivityAD2 blood test simultaneously quantifies specific plasma amyloid beta and tau peptide concentrations to calculate the Aβ42/40 Ratio and p-tau217/np-tau217(p-tau217 Ratio).
  • In this regard, the PrecivityAD2 blood test makes a significant contribution to the diagnosis of patients with Alzheimer’s disease.

Global Reproductive Genetics Market Report 2023: Increasing Demand for Genetic Testing Drives Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 11, 2023

The global reproductive genetics market is anticipated to witness impressive growth during the forecast period.

Key Points: 
  • The global reproductive genetics market is anticipated to witness impressive growth during the forecast period.
  • Additionally, significant growth in advanced testing, along with increasing awareness among different age groups of women for a leading safe life, is further expected to increase the demand for reproductive genetics, thereby fuelling the market growth through 2027.
  • Furthermore, increasing focus on family planning, favorable regulations by the government, and advancements in different testing are further expected to increase the demand for reproductive genetics, thereby supporting market growth.
  • Increasing demand for genetic testing of embryos, either during pregnancy or of those created through IVF to check for possible genetic disorders, is driving the growth of the reproductive genetics market.

FDA Grants De Novo Marketing Authorization for KidneyIntelX.dkd to Assess Risk of Progressive Kidney Function Decline in Adults with Diabetes and Early-Stage Kidney Disease

Retrieved on: 
Thursday, June 29, 2023

LONDON and SALT LAKE CITY, June 29, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (LSE: RENX) (NASDAQ:RNLX) announces that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for its KidneyIntelX.dkd ™ prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease. Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals.

Key Points: 
  • This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease.
  • Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals.
  • This result provides comprehensive information on patient risk for progressive decline in kidney function within five years, independently of the current standard of care measures.
  • KidneyIntelX.dkd is the name used to differentiate tests to be provided under the De Novo marketing authorization by the FDA from those provided under the KidneyIntelX name as a Laboratory Developed Test.

PathomIQ and Neuberg Diagnostics Partner to Deploy Novel AI-based Prognostic and Predictive Biomarker tests in Clinical Practice

Retrieved on: 
Tuesday, June 6, 2023

These tools capture prognostic and predictive histologic features using AI and can identify upfront, patients who are likely to benefit from certain approved and/or experimental therapies.

Key Points: 
  • These tools capture prognostic and predictive histologic features using AI and can identify upfront, patients who are likely to benefit from certain approved and/or experimental therapies.
  • Neuberg Diagnostics is a leading provider of best-in-class molecular and histopathology laboratory services with presence across India, UAE, South Africa and USA.
  • NCGM aka Neuberg Center for Genomic Medicine is a CLIA-certified and HIPAA-compliant laboratory based out of Raleigh, North Carolina and is a part of the Neuberg Diagnostics global laboratory network.
  • "Our mission is to provide cost-effective and best-in-class technologies in clinical laboratory services and make them accessible to people worldwide.