|DiagCore system--Courtesy of Stat-Diagnostica|
Stat-Diagnostica expects to start marketing its DiagCore Near Patient Testing System in Europe next year. To help get it there, the Barcelona, Spain-based startup has raised a €25 million ($28.5 million) Series C round led by prominent European investor Gilde Healthcare.
DiagCore is intended to offer both molecular and immunoassay diagnostics with lab-like performance that's slated for decentralized hospital settings such as critical and emergency medicine units, as well as in clinics and physician offices via a CLIA-waivable feature.
"STAT-Diagnostica's DiagCore system can become the best-in-class platform for decentralized molecular testing, the most attractive growth area in molecular diagnostics today," said Gilde Partner Arthur Franken in a statement. He noted that the company, founded in 2010, has "taken the product from idea to commercial implementation in just a few years, a tremendous achievement that stands to bring significant benefit to practitioners and patients."
The device will enable molecular assays (Stat Molecular) for use in infectious diseases, oncology, coagulation, prenatal, inherited disease and companion diagnostics. It automates sample homogenization, cell disruption and nucleic acid purification.
The immunoassays (Stat-Immuno) will be able to detect critical care markers including sepsis indicator procalcitonin, acute myocardial infarction biomarker troponin, acute kidney injury marker Ngal, C-reactive protein, which is a sign of inflammation, and hCG to determine pregnancy.
|DiagCore test cartridge--Courtesy of Stat-Diagnostica|
The DiagCore analyzer is small and portable; it doesn't have any wet interfaces and its tests remain shelf-stable for 12 months at room temperature. It can perform sample prep on a variety of samples including whole blood, swabs, stool and sputum and offers up to 48-multiplex capabilities via real-time PCR. Results can take as little as 30 minutes or as long as 80 minutes, depending on the assay.
Existing investors Kurma Partners, Ysios Capital, Idinvest Partners, Boehringer Ingelheim Venture Fund, Caixa Capital Risc and Axis also participated in the Series C financing.
"This transaction paves the way for us to become the leader in the decentralized syndromic-approach diagnostics space, the fastest growing segment of in-vitro diagnostics," said Stat-Diagnostica CEO and co-founder Jordi Carrera.
- here is the release