Business Wire

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

Share

Abionic SA, a developer of disruptive nanotechnology-based diagnostic solutions, has announced that its Pancreatic Stone Protein (PSP) test on the abioSCOPE® has been certified by BSI certification agency as complying with the European In-vitro Diagnostic Regulation (IVDR), EU 2017/746. This certification granted by notified bodies like BSI is required for in-vitro diagnostics to continue being sold in the European Union. The IVDR’s extensive requirements were adopted by the European Parliament in 2017 and must now be implemented by May 26, 2022.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220808005159/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

FIVE MINUTES TO SAVE LIVES - Immediate clinical decision-making at your fingertips (Photo: Business Wire)

IVDR becomes mandatory as of May 26, 2022. There are also transitional rules that will allow well-established instruments that have not been IVDR certified, but that entered the EU before, to still be sold until 2025. Depending on their shelf life, they may also be used after 2025. Abionic has been preparing for IVDR compliance since 2019, and chose BSI, a reputable notified body that was authorized to perform this certification process.

“As part of its ongoing commitment to meeting 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,” stated Dr. Iwan Märki, CTO of Abionic.

Improving the management of antibiotic administration

Antibiotics are medicines that are used to prevent and treat bacterial infections, which have revolutionized healthcare since the 1930s and have been paramount in saving millions of lives. However, a systematic overuse and misuse of antibiotics is leading to a concerning increase in the number of antibiotic resistant bacteria, which are becoming harder to treat and causing more severe and fatal infections. International and national healthcare 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. The over-prescription of antibiotics by healthcare workers is a key contributing factor leading to resistance, with a direct relationship between antibiotic consumption and the emergence and dissemination of resistant bacteria strains (Nature. 2013:495(7440):141). Studies have shown that antibiotic therapy is incorrectly prescribed in as many as 60% of patients receiving hospital care and is likely to be even higher outside this environment (Luyt et al., Critical Care, 2014). Aside from contributing to resistance, inappropriate antibiotic use may lead to increased mortality and severe disease, increased healthcare costs, increased lengths of stay in hospital and the need for more complex treatments leading to a higher risk for adverse effects and unwanted drug interactions.

Dr. Samir Vora, infectious disease physician, Geneva, Switzerland, commented: “The PSP assay has the potential to help the physician decide whether or not to start antibiotic therapy, and thus contribute to reducing the two major public health problems of sepsis and antimicrobial resistance.”

Two years after the commercial launch of its sepsis test, Abionic’s expansion is reaching a global scale. With over 50 markets already covered, Abionic’s next big step is the U.S. where sepsis represents the single largest cost to the healthcare system. Clinical trials to support FDA 510(k) submission are well underway. “As we gear up for FDA clearance, it’s very motivating to see how excited the U.S. ecosystem is about our novel approach to detecting sepsis and its potential impact on lifespan and healthcare costs,” said Nelson Dumas, Director of the U.S. Subsidiary of Abionic.

About Abionic

Founded in 2010, Abionic is a Swiss Medtech company commercializing a revolutionary nanofluidic technology, providing healthcare professionals with a fast, simple and universal diagnostic tool. Abionic’s cutting-edge nanotechnology enhances the efficiency and versatility of standard ELISA tests to deliver optimal point of care (POC) treatment options by reducing current biological measuring techniques from the macroscale down to the nanoscale in a multi-analyte environment.

Abionic’s In Vitro Diagnostic (IVD) platform provides lab-quality ultra-fast results from a single drop of patient sample (saliva, blood, urine, etc.) at the POC enabling personalized diagnostics and opening the window of opportunity for immediate treatment. The company is mainly active in acute care and in primary care (COVID-19, allergy, iron deficiency) businesses.

For further information about Abionic, please visit https://www.abionic.com/.
For further information about IVDR, please visit: EUR-Lex

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Dr. Nicolas Durand
CEO
Abionic SA
+41 (0)21 353 33 80
info@abionic.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 21:14:00 CET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

Faster Recoveries, Improved Security: HTEC and G2 Risk Solutions Join Forces to Advance Bankruptcy Management28.3.2024 17:02:00 CET | Press release

HTEC, a global digital consulting, software engineering, and product development company, is announcing a strategic collaboration with G2 Risk Solutions (G2RS), the preeminent provider of end-to-end bankruptcy technology solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328622816/en/ HTEC & G2 Risk Solutions Partnership (Photo: Business Wire) Under the agreement, G2RS will engage HTEC to incorporate its leading-edge technology into G2RS’ premier bankruptcy management platform. As the creators of the most comprehensive national bankruptcy database and the first bankruptcy management portal, G2RS is an industry pioneer. By adding HTEC’s premium engineering to the G2RS technology stack, G2RS will offer new and innovative functionalities to help clients expedite financial recoveries, increase data protection, and reduce operational inefficiencies in the bankruptcy management life cycle. “We are thrilled to be a part o

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 16:00:00 CET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 16:00:00 CET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

Eight new sustainability-themed experiences—exclusive to Yokohama—for convention participants28.3.2024 16:00:00 CET | Press release

In a survey conducted by Yokohama Convention & Visitors Bureau (hereinafter YCVB), many convention attendees expressed particular interest in Yokohama’s culture, sightseeing spots, and local cuisine. In response, YCVB has developed eight new Yokohama Tours for event attendees to enjoy during their free time in Yokohama, keeping in line with our ethos of sustainability. Noge Area Bar-Hopping Tour, complete with guide Known affectionately by locals as Yokohama’s kitchen, Noge is a bustling nightlife spot that is home to over 600 izakaya (Japanese-style pubs). A knowledgeable local guide will lead participants to all the hidden gems in Noge, where they can indulge in distinctive, delicious pub-style food and drink. With easy on-foot accessibility, participants can rest assured this fun night out won’t impact their carbon footprint. Soto Zen Tour of Sojiji, head temple of the Soto Zen school As a prominent Zen sect in Japan, Soto Zen provides one of the best Zen wellness experiences. Durin

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye