Simoa

Quanterix Granted Breakthrough Device Designation from U.S. FDA for Blood-Based p-Tau 217 Test for Alzheimer’s Disease

Retrieved on: 
Monday, March 4, 2024
Research, General Health, Pharmaceutical, Biometrics, Consumer, Clinical Trials, Science, Biotechnology, Neurology, Seniors, FDA, Health, Alzheimer's disease, Pathology, PET, Cerebrospinal fluid, Food, Breakthrough, Risk, Simoa, Biomarker, Deficit spending, Patient, CSF, Diagnosis, Plasma, Corporation, Medical device

The FDA’s Breakthrough Device designation is granted to products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need.

Key Points: 
  • The FDA’s Breakthrough Device designation is granted to products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need.
  • The Simoa p-Tau 217 test described in the Breakthrough Device application is a semi-quantitative in vitro diagnostic immunoassay intended for the measurement of p-Tau 217 concentration in plasma using the Quanterix HD-X immunoassay system.
  • The Breakthrough Device designation for the p-Tau 217 test underscores its potential to significantly impact Alzheimer's disease (AD) diagnosis and treatment.
  • However, Breakthrough Device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved.

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.

Quanterix Launches High Accuracy p-Tau 217 Blood Biomarker Test to Aid Physician Diagnosis of Alzheimer’s Disease

Retrieved on: 
Tuesday, October 24, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Plasma, AD, Simoa, Food, Biomarker, CSF, Neurology, Pathology, Psychiatry, Threonine, Deficit spending, Lucent, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Doctor of Philosophy, PET, Cerebrospinal fluid, CLIA, University of Pittsburgh School of Medicine, Diagnosis, Antibody, Alzheimer's disease, Blood, DSM-IV codes, University, Wilfrid Sellars, Patient, Associate, Medical imaging, Medical device

Lucent Diagnostics, a diagnostics brand of Quanterix Corporation (NASDAQ: QTRX), today announced expansion of its LucentAD product line with the addition of a high accuracy p-Tau 217 blood test for Alzheimer’s disease – LucentAD p-Tau 217.

Key Points: 
  • Lucent Diagnostics, a diagnostics brand of Quanterix Corporation (NASDAQ: QTRX), today announced expansion of its LucentAD product line with the addition of a high accuracy p-Tau 217 blood test for Alzheimer’s disease – LucentAD p-Tau 217.
  • p-Tau 217 has emerged as a top performing biomarker for Alzheimer’s pathology, enabling clinical sensitivity and specificity in blood.
  • Highly sensitive and specific blood-based biomarker tests have the potential to speed diagnosis and expand access to treatments for millions of individuals with early Alzheimer’s disease.
  • LucentAD p-Tau 217 leverages the combination of Quanterix’s ultra-sensitive Simoa® technology and J&J Innovative Medicine’s extensively studied p-Tau 217 antibodies to provide high accuracy with a simplified workflow.

FDA Accelerated Approval of Tofersen Highlights Importance of Blood Neurofilament Light Chain as Surrogate Endpoint in Neurology Therapeutic Trials

Retrieved on: 
Tuesday, April 25, 2023
Science, Research, General Health, Health, FDA, Technology, Genetics, Other Technology, LDT, Partex Group, Therapy, AFL, Serum, Survival, Infection, Limit, Massachusetts General Hospital, Biomarker, Multiple sclerosis, DSM-IV codes, Amyloidosis, Plasma, CLIA, Protein, Corporation, Publication, RRMS, SOD1, Patient, Laboratory, Mass, Blood, Simoa, Laboratory developed test, Neurology, Cardiology, Phase, ALS, News, Disease, Pharmaceutical industry, Medical imaging

This is the first known case in which a blood biomarker was successfully used as a surrogate endpoint for a neurology therapeutic trial to gain accelerated approval, highlighting the potential for other therapeutic trial designs to benefit from including blood NfL measurements.

Key Points: 
  • This is the first known case in which a blood biomarker was successfully used as a surrogate endpoint for a neurology therapeutic trial to gain accelerated approval, highlighting the potential for other therapeutic trial designs to benefit from including blood NfL measurements.
  • This data supported an extended FDA review of tofersen’s new drug application under the accelerated pathway leading to its recent announcement of approval.
  • The FDA’s decision to approve tofersen through its Accelerated Approval Program focused on strong surrogate biomarker data, adding momentum to the use of biomarkers in predicting disease severity and clinical benefit in neurodegenerative diseases.
  • NfL, in particular, has been extensively studied in different neurodegenerative diseases, including Alzheimer’s, spinal muscular atrophy, hereditary transthyretin-mediated amyloidosis, and multiple sclerosis.

AriBio Co., Ltd. to Present Biomarker Data for AR1001 from the Mild to Moderate Alzheimer’s Disease Phase 2 Study at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2023)

Retrieved on: 
Friday, March 31, 2023
Biotechnology, Neurology, Mental Health, Health, Pharmaceutical, Cognition, GFAP, Autophagy, PDE5, Neurogenesis, AFL, Plasma, Patient, Apoptosis, Simoa, CSF, Safety, Pharmaceutical industry

The phase 2 study was a double-blind, randomized, placebo-controlled, multi-center trial to evaluate the safety and preliminary efficacy of AR1001 over 26 and 52 weeks of treatment in patients with mild to moderate Alzheimer’s disease.

Key Points: 
  • The phase 2 study was a double-blind, randomized, placebo-controlled, multi-center trial to evaluate the safety and preliminary efficacy of AR1001 over 26 and 52 weeks of treatment in patients with mild to moderate Alzheimer’s disease.
  • AriBio initiated a phase 3 pivotal trial with 30mg of AR1001 to be administered daily to early and mild Alzheimer’s disease patients in December of 2022.
  • “This biomarker data helps bolster the positive effects seen in cognition with the high dose of AR1001 in the Phase 2 study in mild AD patients.
  • We will continue to collect both CSF and plasma as part of the phase 3 study to analyze as supportive data,” stated Dr. Greeley.

Quanterix Expands Laboratory Developed Test Menu with Launch of Neurofilament Light Chain Test

Retrieved on: 
Monday, January 9, 2023
Health, Neurology, Other Science, Research, Science, Biotechnology, Simoa, Multiple sclerosis, RUO, Blood, Neurodegeneration, CSF, CLIA, Ageing, RRMS, SLAC National Accelerator Laboratory, MS, Laboratory developed test, AFL, HIV, Amyotrophic lateral sclerosis, Corporation, Microangiopathy, LDT, FDA, Risk, Neurology, Plasma, TBI, ISO 15189, Protein, Diagnosis, Central nervous system, CAR, Therapy, Patient, HIV/AIDS, Research, ISO, Stroke, Serum, Nerve, Concussion, Traumatic brain injury, Clinical trial, Cerebrospinal fluid, ALS, Medical device, Pharmaceutical industry, Medical imaging, Parkinsonism

NfL is a well-studied biomarker for neuro-axonal injury with wide applicability to different neurological disorders.

Key Points: 
  • NfL is a well-studied biomarker for neuro-axonal injury with wide applicability to different neurological disorders.
  • Any disorder or injuring force resulting in neuronal damage can lead to the release of NfL into the interstitial fluid and cerebrospinal fluid (CSF).
  • A fraction of these proteins diffuses into the blood, where concentrations are typically 50- to 100-fold lower than in CSF and difficult to measure with conventional immunoassay technologies.
  • “Assessment and monitoring of brain health is incredibly difficult and typically performed in limited fashion by surgery or imaging.

Quanterix’ Simoa® Technology Powers Advances in Alzheimer’s Disease Research Presented at 2021 Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Retrieved on: 
Tuesday, November 16, 2021
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Quality of life, Population, University, Neurology, Lilly, Science, Industry, Dementia, Plasma, Biogen, News, PET, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, NASDAQ, Longevity, Disease, CEO, Technology, Simoa, Inflammation, Infection, Founder, Eli Lilly, Research, Cardiology, Forward-looking statement, Clinical trial, Company, PPH, Antibody, Diagnosis, Pathology, EMERGE, Corporation, Patient, FDA, Pharmaceutical industry, Medical imaging

The findings were presented at the Clinical Trials on Alzheimers Disease (CTAD) conference held on November 9-12, 2021.

Key Points: 
  • The findings were presented at the Clinical Trials on Alzheimers Disease (CTAD) conference held on November 9-12, 2021.
  • The assays represent a new frontier in Alzheimers disease clinical research, enabling new trial designs focused on patients at earlier stages of disease, and facilitating accelerated and more efficient trial enrollment.
  • Biogen Corporation, a global pharmaceutical company, presented data from its Phase 3 EMERGE and ENGAGE studies, which used Quanterix Simoa HD-X technology and assays to measure plasma pTau-181.
  • Quanterix recently announced that its Simoa plasma pTau-181 assay has been granted Breakthrough Device Designation from the FDA for use as an aid in Alzheimers disease diagnosis.

Quanterix Corporation Releases Operating Results for Fourth Quarter and Full Year 2020

Retrieved on: 
Tuesday, March 2, 2021
Mental health, Health, Other Science, General Health, Research, Science, Biomarkers, Biology, Life sciences, Modum, Economy of New York City, NASDAQ, Simoa

Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced financial results for the fourth quarter and 12 months ended December 31, 2020.

Key Points: 
  • Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced financial results for the fourth quarter and 12 months ended December 31, 2020.
  • Quanterix Simoa technology was highlighted in a record 443 new publications in 2020, bringing total Simoa-specific inclusions to over 1,120.
  • William Geist joined Quanterix as Chief Operating Officer to help us sustain and grown our strong momentum across numerous digital biomarker platforms.
  • In conjunction with this announcement, Quanterix Corporation will host a conference call on March 2 at 4:30 p.m., EST.

Quanterix Announces Simoa® Joint Laboratory with WuXi AppTec

Retrieved on: 
Friday, February 12, 2021
Science, Other Science, Research, Other Technology, Technology, Biomarkers, Biology, Life sciences, Branches of biology, Contract research organizations, WuXi AppTec, Simoa, UST, Wuxi, Quanterix, WuXi AppTec

Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced it has entered into an agreement to open a joint Simoa laboratory with WuXi AppTec to improve access to Quanterix industry leading biomarker testing and development offerings across China and the APAC market.

Key Points: 
  • Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced it has entered into an agreement to open a joint Simoa laboratory with WuXi AppTec to improve access to Quanterix industry leading biomarker testing and development offerings across China and the APAC market.
  • The Simoa Joint Lab is the strategic partnership between the two companies and will be established at WuXi AppTecs Shanghai facility.
  • Were excited to provide access to Simoa technology to the APAC region, said Kevin Hrusovsky, Chairman, Chief Executive Officers and President of Quanterix.
  • Starting in 2021, APAC researchers across academia, private research firms and biopharmaceuticals organizations will be able to access Quanterix high-definition Simoa technology and suite of custom biomarker testing, development and validation services offered through the Simoa Joint Lab in Shanghai.

Quanterix Corporation Releases Operating Results for Third Quarter 2020

Retrieved on: 
Thursday, November 5, 2020
Biotechnology, Health, Medical devices, Sigdal, Modum, Biomarkers, Simoa, NASDAQ, Finance

Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced financial results for the three months ending September 30, 2020.

Key Points: 
  • Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced financial results for the three months ending September 30, 2020.
  • Most importantly, we are pleased with our growth potential associated with COVID, MS and upcoming Alzheimers disease trials.
  • Quanterix Simoa technology was highlighted in a record 104 new publications, bringing total Simoa-specific inclusions to over 985.
  • In conjunction with this announcement, Quanterix Corporation will host a conference call on November 5 at 4:30 p.m., EST.