Certification agency BSI has granted the abioSCOPE® device and Abionic’s PSP test IVDR certification for in vitro diagnostics.
This certification is in line with the new European In Vitro Diagnostics Regulation (IVDR) and will be required for products sold in the EU from May 2022. A transitional regulation allows the sale and use of established products that are not IVDR certified. entered the EU before May 2022.
The pancreatic stone protein (PSP) on the abioSCOPE® is the first marker of sepsis, allowing its identification up to 72 hours before the standard treatment in 5 minutes.
The newly certified IVDR PSP test is particularly useful in guiding physicians in the decision to start or modify antibiotic treatment.
LAUSANNE, Switzerland, August 09, 2022–(BUSINESS WIRE)–Abionic SA, a developer of innovative nanotechnology-based diagnostic solutions, announced that its pancreatic stone protein (PSP) test on the abioSCOPE® has been certified by the certification agency BSI as compliant with the European In Vitro Diagnostics Regulation (IVDR), EU 2017/746. This certification issued by notified bodies such as BSI is necessary for in vitro diagnostics to continue to be marketed in the European Union. The detailed requirements of the IVDR were adopted by the European Parliament in 2017 and must now be implemented by May 26, 2022.
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IVDR becomes mandatory from May 26, 2022. There are also transitional rules that will allow well-established instruments that have not been IVDR certified, but entered the EU before, to still be sold until in 2025. Depending on their shelf life, they can also be used after 2025. Abionic has been preparing for IVDR compliance since 2019 and has chosen BSI, a reputable notified body that has been authorized to carry out this certification process.
“As part of its continued commitment to the highest standards to ensure patient safety and meet customer needs, Abionic is proud to have achieved the required IVDR certification for its Class C product,” said the Dr. Iwan Märki, CTO of Abionic.
Improve management of antibiotic administration
Antibiotics are drugs used to prevent and treat bacterial infections, which have revolutionized healthcare since the 1930s and have been essential in saving millions of lives. However, systematic overuse and misuse of antibiotics is leading to a worrying rise in the number of antibiotic-resistant bacteria, which are becoming harder to treat and causing more serious and deadly infections. International and national health organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) have identified antibiotic resistance as one of the biggest threats to global health today. today. Overprescription of antibiotics by healthcare workers is a key contributing factor leading to resistance, with a direct relationship between antibiotic consumption and the emergence and spread of resistant bacterial strains (Nature. 2013:495(7440 ):141). Studies have shown that antibiotic therapy is misprescribed in up to 60% of patients receiving hospital care and is likely to be even higher outside of this setting (Luyt et al., Critical Care, 2014 ). In addition to contributing to resistance, the inappropriate use of antibiotics can lead to increased mortality and serious illness, increased health care costs, increased length of hospital stays and the need more complex treatments resulting in a higher risk of adverse effects and adverse drug interactions.
Dr Samir Vora, Infectious Diseases Physician, Geneva, Switzerland, said: “The PSP test has the potential to help the physician decide whether or not to start antibiotic therapy, and thus help reduce the two major problems of public health issues of sepsis and antimicrobial resistance.”
Two years after the commercial launch of its sepsis test, Abionic’s expansion is taking on a global dimension. With more than 50 markets already covered, Abionic’s next big step is the United States where sepsis is the single largest cost to the healthcare system. Clinical trials in support of the FDA 510(k) submission are well underway. “As we prepare to obtain FDA clearance, it is very motivating to see how excited the US ecosystem is about our new approach to detecting sepsis and its potential impact on lifespan and patients. health care costs,” said Nelson Dumas, director of Abionic’s US subsidiary.
Founded in 2010, Abionic is a Swiss Medtech company marketing revolutionary nanofluidic technology, offering healthcare professionals a rapid, simple and universal diagnostic tool. Abionic’s state-of-the-art nanotechnology improves the efficiency and versatility of standard ELISA tests to provide optimal point-of-care (POC) processing options by reducing current biological measurement techniques from macro to nanoscale in a multi-analyte environment.
Abionic’s In Vitro Diagnostics (IVD) platform delivers ultra-fast lab-quality results from a single drop of patient sample (saliva, blood, urine, etc.) to the POC enabling personalized diagnosis and opening the window of opportunity for immediate treatment. The company is mainly active in the areas of acute care and primary care (COVID-19, allergy, iron deficiency).
For more information about Abionic, please visit https://www.abionic.com/.
For more information on the IVDR, please see: EUR-Lex
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Dr Nicolas Durand
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