PRESS RELEASE – SpinChip Diagnostics’ Point-of-Care platform demonstrates diagnostic performance on par with state-of-the-art clinically validated laboratory analyzers
Oslo, (8 June 2023) — SpinChip Diagnostics AS (SpinChip), a pioneering diagnostics company developing a next-generation point-of-care (POC) platform for in vitro diagnostics, today announced positive results from a diagnostic study using biobank samples from the prospective international APACE (Advantageous Predictors of Acute Coronary Syndrome Evaluation) study.
The study aimed to evaluate the diagnostic accuracy of SpinChip’s POC diagnostic platform for the early diagnosis of Acute Myocardial Infarction (MI) and to compare the results with state-of-the-art laboratory analyzers. SpinChip’s diagnostics platform has been developed to use a droplet of blood to deliver accurate and reliable results in 10 minutes. It is designed to be at or near the site of patient care.
The study was performed with blinded measurements of 3 293 plasma samples from 1 182 consecutively enrolled patients. The diagnosis of MI was adjudicated by two independent cardiologists applying the 4th Universal Definition of Myocardial Infarction (UDMI) using all available medical records including study-specific assessments.
For patients presenting with chest pain at the emergency department, the SpinChip high sensitivity cardiac Troponin I (hs cTnI) assay displayed very high diagnostic accuracy, comparable to the laboratory hs-cTnT – Elecsys (Roche) and hs-cTnI-Architect (Abbott) assays. Comparable results were also obtained in the subgroup of early (symptom onset <3 h) and late presenters (symptom onset >12 h).
Professor Christian Mueller, Principal investigator of the APACE study, commented:
“The comparable diagnostic performance of the SpinChip POC hs cTnI assay and established lab testing is impressive and very good news for patients and physicians.”
Morten Jurs, Chief Executive Officer of SpinChip Diagnostics, added:
“We are thrilled by the SpinChip results from the APACE study samples, which takes us one step closer to commercializing our POC diagnostics platform. The data also serve as proof of concept going into clinical studies for regulatory approval. We are confident that these results will encourage a further transition from clinical laboratory to near-patient diagnostics in acute settings.”
Stig Morten Borch, Founder and Chief Scientific Officer
Phone: +47 991 67 922
Hamed Brodersen, Chief Financial Officer
Phone: +47 404 68 110
About SpinChip Diagnostics AS
Representing the future of point-of-care testing, SpinChip Diagnostics was founded in Norway in 2012. SpinChip’s proprietary platform is focused on in vitro diagnostics (IVD) to develop diagnostic tests for acute and chronic cardiac indications where test results are rapidly needed to provide patients with life-saving treatments. The platform is based on microfluidic technology in combination with nanotechnology-based cartridge assays, which together can relay test results as accurately as high-sensitive laboratory diagnostic machines within minutes, from only a fraction of a droplet of blood.
About the APACE study
The aim of the APACE (Advantageous Predictors of Acute Coronary Syndrome Evaluation) Study is to test if the use of meticulous patient history, digital and analogue ECG parameters and novel biomarkers (including high-sensitivity cardiac troponin I and T and other novel biomarkers) can provide a faster detection or exclusion of acute myocardial infarction in patients presenting with acute chest pain to the emergency department.
Visit www.spinchip.no – Next generation point-of-care diagnostics