Abionic

Abionic Receives IVDR Certification for Its Predictive Ultra-Rapid Sepsis Test Allowing the Management of Antibiotic Administration

Retrieved on: 
Tuesday, August 9, 2022
Technology, Medical Supplies, Infectious Diseases, FDA, Nanotechnology, Clinical Trials, Biotechnology, Other Health, Health, FDA, FIVE, Multimedia, Union, World Health Organization, Risk, Patient safety, Mortality, Decision-making, BSI, POC, Ecosystem, PSP, Center, Infection, IVDR, Saliva, Nature, ELISA, Environment, Urine, Compliance, Blood, Allergy, European, Patient, CDC, COVID-19, International, European Parliament, CTO, Critical care, Health, Sepsis, WHO, World, IVD, Luyt, Korea Disease Control and Prevention Agency, Immediate, Medtech, Certification, Drug, Efficiency, Medical device, Pharmaceutical industry, Abionic, EU

This certification granted by notified bodies like BSI is required for in-vitro diagnostics to continue being sold in the European Union.

Key Points: 
  • This certification granted by notified bodies like BSI is required for in-vitro diagnostics to continue being sold in the European Union.
  • The IVDRs extensive requirements were adopted by the European Parliament in 2017 and must now be implemented by May 26, 2022.
  • Abionic has been preparing for IVDR compliance since 2019, and chose BSI, a reputable notified body that was authorized to perform this certification process.
  • Two years after the commercial launch of its sepsis test, Abionics expansion is reaching a global scale.

Abionic launches ultra-fast on site COVID-19 Saliva Test aimed at schools, hotels, airports and restaurants

Retrieved on: 
Tuesday, November 30, 2021
Patient, School, European Union, Saliva, PCR, Antigen, Severe acute respiratory syndrome coronavirus 2, Reliability, IVD, Abionic, Education, Vaccination, Physician, Pharynx, Restaurant, Union, Person, CE marking, Airport, Vaccine

This milestone allows Abionic to commercialize its ultra-fast test for identifying individuals infected by SARS-CoV-2 throughout the European Union.

Key Points: 
  • This milestone allows Abionic to commercialize its ultra-fast test for identifying individuals infected by SARS-CoV-2 throughout the European Union.
  • The ultra-fast IVD CAPSULE COVID-19 test using a saliva sample has been compared to Cobas 6800 UNICOVID saliva RT-PCR and showed very good correspondence.
  • The test detects the presence of the nucleoprotein inside the SARS-CoV-2 virus, and thus can be used for assessing the contagiousness of an individual.
  • Abionic's In Vitro Diagnostic (IVD) platform provides lab-quality ultra-fast results from a single drop of patient sample (saliva, blood, urine, etc.)

Abionic Integrates First Patients in US Clinical Trial for Sepsis Diagnosis Method

Retrieved on: 
Thursday, January 9, 2020
Research, Other Health, Pharmaceutical, Technology, Medical devices, Infectious diseases, Hospitals, Clinical trials, Science, Biotechnology, FDA, Practice Management, Health, Medical specialties, Medicine, Intensive care medicine, Medical emergencies, Neonatology, RTT, Sepsis, Inflammation, Sepsis Alliance, Neonatal sepsis, Abionic, the technology underlying abioSCOPE

The PSP test on the abioSCOPE can diagnose sepsis 24 hours earlier than todays standard of care for sepsis diagnosis.

Key Points: 
  • The PSP test on the abioSCOPE can diagnose sepsis 24 hours earlier than todays standard of care for sepsis diagnosis.
  • As indicated by earlier studies, PSP is the best marker to distinguish sepsis from non-infectious inflammation.
  • Of the 30 million people that are affected by sepsis each year, nine million cases are fatal.
  • If sepsis is diagnosed and treated in the first hour, the patients chances of survival exceed 80%.

Abionic: International Pivotal Study Successfully Demonstrates Diagnosis of Sepsis within 5 Minutes – 24 Hours Earlier Compared with Current Standard-of-Care

Retrieved on: 
Friday, September 13, 2019
Research, Infectious diseases, Clinical trials, Biotechnology, Pharmaceutical, Health, Science, Medical specialties, Medicine, Intensive care medicine, Neonatology, Medical emergencies, RTT, Sepsis, Neonatal sepsis, the PSP Sepsis Test on the abioSCOPE, Abionic

The results of the study show an anticipation of 24 hours for the diagnosis of sepsis compared to current standard of care.

Key Points: 
  • The results of the study show an anticipation of 24 hours for the diagnosis of sepsis compared to current standard of care.
  • During the study, the majority of patients who developed sepsis already showed high PSP concentration values 24 hours before the diagnosis with current methods.
  • Time being critical with this condition, the outcome for patients could dramatically be improved with a gain of 24 hours.
  • Our study demonstrates that, from a drop of blood and in 5 minutes sepsis can be identified several dozen of hours upfront than todays standard of care.

Abionic Signs Agreement to Optimize Asthma Management in the U.S. through Innovative Rapid Point-of-Care Tests

Retrieved on: 
Thursday, September 5, 2019
Biotechnology, Pharmaceutical, Health, Medical devices, Hospitals, Other Health, Medical specialties, Medicine, Immune system, Immunology, RTT, Allergology, Allergy, Asthma, Allergen, Pathophysiology of asthma, Occupational hazards of human nail dust, allergic asthma, Abionic

At Abionic we are focused on delivering true patient-centric diagnostic solutions, which means a rapid, reliable test available at any time, from anywhere, whenever a patient needs it.

Key Points: 
  • At Abionic we are focused on delivering true patient-centric diagnostic solutions, which means a rapid, reliable test available at any time, from anywhere, whenever a patient needs it.
  • The agreement with Genentech, a leader in developing novel medicines in respiratory diseases including allergic asthma, is a great step towards more personalized and precise diagnostics, commented Nicolas Durand, PhD, Chief Executive Officer of Abionic.
  • Allergic asthma is a subtype of asthma caused by the exposure and hypersensitivity to allergens.
  • Allergic asthma is diagnosed by medical history, physical examination, lung function testing, skin testing and/or laboratory tests that identify sensitization to allergens.