Business Wire

biosurfit Receives CE Mark for Its spinit® HbA1c Point-of-Care Blood Test to Assist Doctors Diagnose and Monitor Diabetes

Del

Today, biosurfit SA (“biosurfit”), the in vitro point-of-care (PoC) diagnostics company, announces CE Marking (Conformité Européenne) for its HbA1c (Haemoglobin A1c) test, the third in a series of tests available on its spinit® point-of-care instrument.

The CE Mark approval of the HbA1c clinical chemistry test signifies the latest advancement of biosurfit’s spinit®, the first and only, PoC diagnostic system capable of performing all three of the major blood tests (haematology, immunoassays and clinical chemistry) on the same instrument. The spinit® test could also signal cost-efficiencies for physicians who can now use just one instrument, instead of several ones. Existing, commercially launched tests for the spinit® instrument include CRP (c-reactive protein) and BC (blood count).

The HbA1c test is one of the key diagnostic tests used by physicians to diagnose and monitor diabetes as well as to identify patients at risk of developing diabetes. With a requirement for a tiny finger stick blood sample of only 5µl, the new spinit® clinical chemistry HbA1c test allows physicians to manage the progression of this very serious disease in a few minutes. HbA1c is one of the most commonly used PoC tests performed in physicians’ offices. With the CE marking of biosurfit’s spinit® HbA1c test, biosurfit is now able to offer this valuable tool to help physicians efficiently diagnose and monitor diabetes without having to collect and send blood samples off to a central laboratory.

With the new HbA1c test, along with CRP and Blood cell counting, biosurfit now offers a comprehensive menu of fast, easy to perform laboratory quality tests on the spinit® instrument. The combination of different detection methods on the CD/DVD format of the spinit® disc along with powerful microfluidics will facilitate the development of the pipeline of products in the near future, including a lipid panel, an inflammation panel and a d-dimer test. This attractive menu of tests, on a rapid and simple to use instrument will allow the performance of these key tests in GP offices, clinics, pharmacies and other PoC testing sites.

João Garcia da Fonseca, Chief Executive Officer of biosurfit, commented: “We are delighted to have secured this new and important milestone in the continuous development of spinit®. It is a clear testament to its disruptive, technical viability and rising commercial acceptance in setting the future gold standard in IVD PoC diagnostics. We are looking forward to continuing the roll out and commercialisation of the expanded spinit® test menu in the near future.”

Ian Gilham, Chairman of biosurfit, commented: “CE-Marking of the HbA1c test is a major milestone in the development of the spinit instrument and test menu providing an indispensable aid to patients and physicians in their fight against diabetes. We are excited by the ever expanding menu of spinit tests and the increased installed base of instruments which will be further driven by the launch of new tests and the opening of new global markets in the near future.”

Notes to editors

About biosurfit and spinit ®

biosurfit is a fast-growing and highly innovative commercial stage European medical diagnostics company focused on the development and manufacture of breakthrough technologies for the in vitro diagnostic (IVD) market. Its lead product spinit®, which was commercially launched in 2014, addresses an unmet need for fast, precise, reliable, easy-to-use blood analysis for medical testing in the PoC setting.

1 International Diabetes Federation. IDF Diabetes Atlas, 7th edition, Brussels, Belgium: International Diabetes Federation; http://www.diabetesatlas.org. Accessed 6 November 2016.

2 NIH – National Institute of Diabetes and Digestive and Kidney Diseases: The A1C Test and Diabetes; www.niddk.nih.gov. September 2014.

Contact information

FTI Consulting (media relations)
Con Franklin
con.franklin@fticonsulting.com
+44 (0)203 727 1000
or
biosurfit SA
João Garcia da Fonseca, Chief Executive Officer
Daniel Neves, Chief Marketing Officer / Chief Financial Officer
+351 218 860 169

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Philip Morris International Releases Latest Scientific Update for Smoke-Free Products on Clinical Program12.12.2017 15:23Pressemelding

Philip Morris International Inc. (PMI) (NYSE/Euronext Paris: PM) today released its latest Scientific Update for Smoke-Free Products, a regular publication on its research efforts to develop and assess a range of smoke-free alternatives to cigarettes. The latest issue of the Scientific Update can be found at this link. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171212005891/en/ Philip Morris International Releases Latest Scientific Update for Smoke-Free Products on Clinical Program (Photo: Business Wire) This issue of the Scientific Update provides a closer look at some of the principles and practices on which PMI’s scientific assessment program is built. Director Medical Affairs Dr. Patrick Picavet describes specific examples from PMI’s clinical program that highlight the company’s

Murex to Offer MX.3 Risk, Trading and Post-Trade Solutions on the AWS Cloud12.12.2017 14:00Pressemelding

Murex, an industry leader in trading, risk management and processing solutions for capital markets, announced they will run their MX.3 technology platform on Amazon Web Services, Inc. (AWS). With the acceleration of cloud adoption in capital markets, Murex and AWS agreed to collaborate to help clients migrate their Murex application workloads to the AWS Cloud. Murex clients are looking to consolidate more and more of their capital markets activity on the MX.3 platform and this means their need for infrastructure is increasing. New regulatory requirements are also driving financial organizations to use cloud to scale up their computing capacity. Murex is collaborating with AWS to meet the demand from clients to support deployment of the Murex offering on the AWS Cloud. Murex is working on the validation of a range of deployment scenarios, from using AWS Cloud for bursting grid

Darzalex®▼(daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible12.12.2017 13:33Pressemelding

Janssen-Cilag International NV (“Janssen”) today announced data from the Phase 3 ALCYONE study, showing Darzalex® (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) significantly improved clinical outcomes, including reducing the risk of disease progression or death by 50 percent, in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).1 These data were accepted as a late-breaking abstract (LBA) for presentation at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, today at 7:30 a.m. ET (Abstract #LBA-4).1 Study findings were simultaneously published in the New England Journal of Medicine (NEJM) . 2 Daratumumab is currently indicated for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for

CTS Engines Announces Senior Management Hire12.12.2017 13:00Pressemelding

CTS Engines, the global leader for mature jet engine maintenance, announced today that it had hired Diane E. Cavuoto as Senior Vice President, Supply Chain, in an effort to continue to provide its customers with outstanding engine overhaul services. Ms. Cavuoto will be based in CTS’s Ft. Lauderdale headquarters and will report directly to Vesa Paukkeri, CTS’s President and Chief Operating Officer. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171212005050/en/ Diane E. Cavuoto, Senior Vice President, Supply Chain, for CTS Engines (Photo: Business Wire) Ms. Cavuoto, most recently Vice President, Strategic Sourcing at Honeywell International, brings years of supply chain management experience to CTS. In her prior role at Honeywell, Ms. Cavuoto managed a global commodity team of 150 employees managing $4

MIPI Alliance Opens Access to its MIPI I3C Sensor Interface Specification12.12.2017 13:00Pressemelding

The MIPI® Alliance, an international organization that develops interface specifications for mobile and mobile-influenced industries, today announced it is opening access to its sensor interface specification, MIPI I3C. Starting today, all companies, including those not currently members of MIPI Alliance, may access the MIPI I3C v1.0 specification so they may evaluate the incorporation of the specification into their sensor integration plans and design applications. “MIPI I3C provides a welcome update to the I2C technology that has been widely adopted over the past 35 years. Extending access provides an opportunity to spur innovation and help other industries beyond mobile," said Joel Huloux, chairman of MIPI Alliance. "It helps MIPI members as well, because it supports greater adoption and interoperability, strengthens the ecosystem and provides for a richer

ADC Therapeutics Announces Interim Phase I Data from its Novel Antibody-Drug Conjugate ADCT-30112.12.2017 11:23Pressemelding

ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, today announced clinical data from two ongoing Phase I clinical trials evaluating ADCT-301 (camidanlumab tesirine or “Cami-T”) in important subtypes of lymphoma and leukemia. The data were presented at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, USA. 1. Interim results of a Phase I open label, single agent, dose-escalating study of ADCT-301 evaluating tolerability, safety, pharmacokinetics and efficacy in patients with relapsed or refractory B-cell Hodgkin’s or non-Hodgkin’s lymphoma Dr. Steven M. Horwitz, Medical Oncologist at Memorial Sloan Kettering Cancer Center in New York City, and Principal Investigator, s

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom