Biosurfit

Biosurfit is a Portuguese diagnostics and biotechnology company based in Lisbon that focuses on the development, manufacture and distribution of in-vitro diagnostic (IVD) tests for the point-of-care (PoC) market. Its flagship product is the spinit platform, a compact instrument that works with single-use disposable discs to run multiple diagnostic tests from a small blood sample, typically obtained by finger prick. The company describes its technology as bringing miniaturisation and technological improvements to point-of-care testing, allowing laboratory-quality results to be delivered quickly and accurately during a single patient consultation. The spinit system integrates immunoassays, haematology and clinical chemistry analytes on the same disposable disc, so clinicians can combine the parameters they need to make diagnostic or treatment decisions. Documented tests include spinit CRP for quantitative measurement of C-Reactive Protein, spinit BC for blood count with total white blood cells and 5-part differential counts, and spinit HbA1c. The spinit BC disc, for example, uses an 8 µL sample of whole blood (venous EDTA or capillary), runs in about 7 minutes and is supplied in kits of 20 separately packed discs. Beyond its own diagnostic products, Biosurfit positions itself as a contract development and manufacturing organisation (CDMO) for the healthcare industry. It offers contract development and contract manufacturing services, leveraging a portfolio of patents and expertise in microfluidics to provide turnkey solutions for companies seeking advanced diagnostic manufacturing. The company states that it is dedicated to providing comprehensive contract development and manufacturing services alongside its own IVD portfolio. Biosurfit's stated mission is to shape the future of in-vitro diagnostic testing so that health providers have the information they need to make the best possible diagnostic and treatment decisions while with their patients. Its values are described as Innovative, Excellent, Responsible and Fair, and the company says it guides its activities under a socially responsible code of ethical conduct covering relationships with employees, shareholders, customers, suppliers, universities and partners. The company has built a track record since the mid-2000s, including ISO 9001 and ISO 13485 certification, CE marking of the spinit instrument and its first test, European distribution agreements, European Union and European Investment Bank funding, and launches across multiple countries. It remains a private Portuguese company headquartered in Lisbon.

Biosurfit's own published track record begins in 2006, when the company won the ANJE (Associação Nacional de Jovens Empresários) entrepreneur of the year award. In 2009 it received ISO 9001:2008 and ISO 13485:2004 certification from TÜV Rheinland, establishing a quality-management foundation for medical-device development. The following year, 2010, brought the "Hospital do Futuro" award and the results of a point-of-care medical test market research project delivered by IMS Healthcare. In 2011 Biosurfit won the Growth Companies Competition at the HiTBarcelona World Innovation Summit. A semi-automated production line was validated in 2012, and in the same year the company achieved CE Marking for the spinit instrument and its first test, spinit CRP, for quantitative measurement of C-Reactive Protein in blood. This CE mark was a pivotal step, allowing the platform to be commercialised in Europe. 2013 was a year of recognition and market entry: Biosurfit won Start-up of the Year from Portugal Ventures, exhibited for the first time at MEDICA (described as the world's largest medicine forum), signed its first distribution agreement in June with Rev Diagnostics of the Netherlands, and was awarded a €1.4 million grant by the European Commission's 7th Framework Programme. In February 2014 the company recorded its first commercial sale in the Netherlands, and in May 2014 it received CE Mark for the spinit Blood Count test. Funding and expansion continued in 2015, when Biosurfit secured a €12 million loan from the European Investment Bank and €4.3 million of public funding from the European Union's PT2020 programme, and won "Life Sciences & Med Tech Venture of the Year" from Portugal Ventures. In 2016 the company received CE mark for the spinit HbA1c test, signed several distribution contracts in Europe, and launched spinit in 13 different countries. In 2017 it obtained IFCC and NGSP certification for spinit HbA1c and won an award of distinction, "Born from Knowledge", at the 14th National Meeting of Innovation. Biosurfit's published timeline continues through 2024, reflecting ongoing development of its point-of-care platform and its contract development and manufacturing activities. Today the company presents itself as both an IVD product developer — with the spinit platform integrating immunoassays, haematology and clinical chemistry on a single disposable disc — and a CDMO offering contract development and contract manufacturing services built on its patent portfolio and microfluidics expertise.

• 2017

  Obtains IFCC and NGSP certification for spinit HbA1c; wins award of distinction "Born from Knowledge" at the 14th National Meeting of Innovation.

• 2016

  Receives CE mark for spinit HbA1c test; signs several distribution contracts in Europe; spinit launched in 13 different countries.

• 2015

  Secures €12 million loan from the European Investment Bank; secures €4.3m public funding from EU PT2020 programme; wins "Life Sciences & Med Tech Venture of the Year" from Portugal Ventures.

• 2014

  First commercial sale in the Netherlands (February); receives CE Mark for spinit Blood Count test (May).

• 2013

  Wins Start-up of the Year from Portugal Ventures; exhibits at MEDICA for the first time; signs first distribution agreement with Rev Diagnostics, The Netherlands; awarded €1.4m grant by the European Commission's 7th Framework Programme.

• 2012

  Semi-automated production line validated; receives CE Marking for the spinit instrument and the first test, spinit CRP.

• 2011

  Wins the Growth Companies Competition at the HiTBarcelona World Innovation Summit.

• 2010

  Wins the "Hospital do Futuro" award and receives results of the point-of-care medical test market research project delivered by IMS Healthcare.

• 2009

  Receives ISO 9001:2008 and ISO 13485:2004 certification from TÜV Rheinland.

• 2006

  Biosurfit wins ANJE (Associação Nacional de Jovens Empresários) entrepreneur of the year award.

Point-of-care IVD developer and CDMO offering lab-quality, multi-parameter diagnostics from a single finger-prick sample.

• spinit instrument

  Compact point-of-care diagnostic instrument that reads single-use disposable discs.

• spinit CRP

  Quantitative measurement of C-Reactive Protein in blood; first test to receive CE Marking in 2012.

• spinit BC Blood Count

  Disposable disc used with the spinit instrument for total white blood cells and 5-part differential counts; 8 µL sample, ~7 min assay time, kits of 20 tests.

• spinit HbA1c

  HbA1c test that received CE mark in 2016 and IFCC/NGSP certification in 2017.

• Contract development and manufacturing services

  CDMO services leveraging patents and microfluidics expertise for diagnostic and healthcare customers.

1. 1biosurfit official websitebiosurfit.com
2. 2Company - biosurfitbiosurfit.com
3. 3History - biosurfitbiosurfit.com
4. 4Products Catalog - biosurfitbiosurfit.com
5. 5Biosurfit (Portugal) - Wikidatawikidata.org