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Abionic SA

Home Clinical Trial Sponsors and OrganizationsAbionic SA

Abionic SA

secteur Esplanade SE-B, Epalinges, Vaud, Switzerlandwww.abionic.comEstablished: 2010-01-01

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Clinical Trials

8

0 active

Approvals

0

Total approvals

Agencies

0

Regulatory bodies

Founded

2010

Overview

Trial Phase Distribution

No trial phase data available

Trial Status Distribution

Completed

6

75.0%

Withdrawn

2

25.0%

Clinical Trials

Trials sponsored by this organization (8)

abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003

Jul 202361 participants

Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2

Oct 2022440 participants

Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

Aug 202246 participants

Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population

Nov 2021150 participants

abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation

Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis

Dec 2019544 participants

Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial.Pancreatic Stone Protein (PSP) Measured Using the AbioScope.

Jun 2018296 participants

Approvals

No approval data available

News

Abionic's CAPSULE PSP Receives FDA Approval for Early Sepsis Detection

- Abionic's CAPSULE PSP, an innovative test for early sepsis detection, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). - The CAPSULE PSP test measures Pancreatic Stone Protein (PSP), a biomarker that rises in response to infections and inflammation, enabling earlier sepsis detection. - Fapon has secured exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China through a strategic partnership with Abionic SA and LASCCO SA. - Fapon is developing and commercializing PSP on its chemiluminescent immunoassay (CLIA) analyzer for the Chinese market, leveraging the FDA approval and strategic collaboration.

On this page

Overview
Clinical Trials8
Approvals
News1

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