C2N Diagnostics
Specialty diagnostics company focused on blood-based biomarker measurement and bioanalytical services for Alzheimer’s disease and related neurodegenerative disorders. Core activities include development and validation of high-resolution LC-MS/MS assays, operation of an accredited clinical laboratory under established quality systems, translational biomarker research, participation in multicenter clinical validation studies, and international laboratory partnerships to support clinical care and trials.
Industries
Nr. of Employees
medium (51-250)
C2N Diagnostics
Patents
Methods for the diagnosis and treatment of neurological and neurodegenerative diseases, disorders and associated processes
US-12253529-B2
View DetailsMethods for the diagnosis and treatment of neurological and neurodegenerative diseases, disorders and associated processes
US-10261097-B2
View Details
Methods for the diagnosis and treatment of neurological and neurodegenerative diseases, disorders and associated processes
US-12253529-B2
View DetailsMethods for the diagnosis and treatment of neurological and neurodegenerative diseases, disorders and associated processes
US-10261097-B2
View DetailsProducts
Laboratory-performed blood biomarker test for amyloid and tau pathology
Clinical laboratory blood test measuring plasma amyloid peptide ratios and phosphorylated tau isoforms, combined into a multi-analyte algorithmic score to estimate likelihood of brain amyloid pathology in symptomatic adults undergoing cognitive evaluation.
Precivity-ApoE
A blood test indicated for use in adult patients for whom knowledge of apolipoprotein E2,E3,E4 allele status may be informative for medical management and treatment decisions.
Precivity-ApoE(TM)
Blood test indicated for use in adult patients for whom knowledge of apolipoprotein E2,E3,E4 allele status may be informative for medical management and treatment decisions.
PrecivityAD2@
Blood test intended for use in patients aged 50 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia.
PrecivityAD@
Blood test intended for use in patients age 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia.
C2N Biopharma Clinical Research Services
Mass spectrometry-based identification, quantification, and monitoring of proteins, protein fragments, and other biomolecules implicated in human neurological diseases for clinical research and biopharma clients.
Laboratory-performed blood biomarker test for amyloid and tau pathology
Clinical laboratory blood test measuring plasma amyloid peptide ratios and phosphorylated tau isoforms, combined into a multi-analyte algorithmic score to estimate likelihood of brain amyloid pathology in symptomatic adults undergoing cognitive evaluation.
Precivity-ApoE
A blood test indicated for use in adult patients for whom knowledge of apolipoprotein E2,E3,E4 allele status may be informative for medical management and treatment decisions.
Precivity-ApoE(TM)
Blood test indicated for use in adult patients for whom knowledge of apolipoprotein E2,E3,E4 allele status may be informative for medical management and treatment decisions.
PrecivityAD2@
Blood test intended for use in patients aged 50 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia.
PrecivityAD@
Blood test intended for use in patients age 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia.
C2N Biopharma Clinical Research Services
Mass spectrometry-based identification, quantification, and monitoring of proteins, protein fragments, and other biomolecules implicated in human neurological diseases for clinical research and biopharma clients.
Services
Laboratory-performed blood and CSF biomarker testing for amyloid and tau markers to aid clinical evaluation of cognitive impairment; testing is provided under accredited clinical laboratory operations and is available by order of licensed health care professionals.
Assay and laboratory services to support trial screening and biomarker endpoint measurement, including rapid turnaround reporting, customized data deliveries for sponsors, and project management for study duration.
Collaborative R&D agreements for biomarker discovery, assay validation, kinetic isotope studies, and analytic support for therapeutic development and clinical validation studies.
Laboratory-performed blood and CSF biomarker testing for amyloid and tau markers to aid clinical evaluation of cognitive impairment; testing is provided under accredited clinical laboratory operations and is available by order of licensed health care professionals.
Assay and laboratory services to support trial screening and biomarker endpoint measurement, including rapid turnaround reporting, customized data deliveries for sponsors, and project management for study duration.
Collaborative R&D agreements for biomarker discovery, assay validation, kinetic isotope studies, and analytic support for therapeutic development and clinical validation studies.
Expertise Areas
- Targeted proteomics using LC-MS/MS
- Biomarker assay development and analytical validation
- Clinical laboratory diagnostics for neurodegenerative disease
- Bioanalytical support for clinical trials and translational studies
Key Technologies
- High-resolution liquid chromatography-tandem mass spectrometry (LC-MS/MS)
- Immunoprecipitation-coupled mass spectrometry workflows
- Targeted quantitative proteomics
- Stable isotope-labeled internal standards
News & Updates
U.S. FDA cleared a blood-based diagnostic test that combines mass spectrometry measurements and a multi-analyte algorithm to aid evaluation of Alzheimer’s disease in symptomatic adults aged 40 and older.
A large U.S. insurer established medical policy coverage for a blood-based biomarker test to aid Alzheimer’s disease evaluation, expanding access for eligible members.
Researchers at an NHS site implemented a blood-based biomarker test into primary care assessment workflows to evaluate its accuracy and impact on early diagnosis and referral pathways for cognitive impairment.
Collaboration with a regional diagnostics partner to implement test availability, local logistics, and physician outreach across multiple countries in Latin America and the Caribbean.
First reported use of a tau243 plasma assay in Phase 3 trial data analyses showed independent and complementary associations with longitudinal cognitive and functional decline.
Received a New York State clinical laboratory permit, enabling laboratory testing availability in New York and completing nationwide availability in the U.S.
U.S. FDA cleared a blood-based diagnostic test that combines mass spectrometry measurements and a multi-analyte algorithm to aid evaluation of Alzheimer’s disease in symptomatic adults aged 40 and older.
A large U.S. insurer established medical policy coverage for a blood-based biomarker test to aid Alzheimer’s disease evaluation, expanding access for eligible members.
Researchers at an NHS site implemented a blood-based biomarker test into primary care assessment workflows to evaluate its accuracy and impact on early diagnosis and referral pathways for cognitive impairment.
Collaboration with a regional diagnostics partner to implement test availability, local logistics, and physician outreach across multiple countries in Latin America and the Caribbean.
First reported use of a tau243 plasma assay in Phase 3 trial data analyses showed independent and complementary associations with longitudinal cognitive and functional decline.
Received a New York State clinical laboratory permit, enabling laboratory testing availability in New York and completing nationwide availability in the U.S.