Diabetomics is partnering with EU consortium project EDENT1FI to introduce innovative rapid point-of-care tests for Type 1 diabetes screening.
https://www.edent1fi.eu/our-partners
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Five landmark clinical studies were published on glycosylated fibronectin as a new biomarker and rapid point-of-care test for risk assessment of preeclampsia
Sokratous, N., Wright, A., Syngelaki, A., Kakouri, E., Laich, A. and Nicolaides, K.H. (2023), Screening for pre-eclampsia by maternal serum glycosylated fibronectin and angiogenic markers at 36 weeks’ gestation. Ultrasound Obstet Gynecol. Accepted Author Manuscript. Sokratous, N., Bednorz, M., Syngelaki, A., Wright, A., Nicolaides, K.H. and Kametas, N.A. (2023), Prediction of superimposed pre-eclampsia by serum glycosylated …
Publication of rapid point-of-care test for detection of rheumatoid arthritis
Diabetomics has developed the first rapid point-of-care test for the autoimmune biomarker anti-citrullinated albumin (ACA). The ACA test compliments the current ACCP (anti-cyclic citrullinated peptide) diagnostic test. The test can use a non-invasive saliva sample or a fingerstick sample. The availability of this test will facilitate early clinical stratification of rheumatoid arthritis and the implementation …
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Regulatory approvals for Diabetomics’ rapid point-of-care tests for detection of glutamic acid decarboxylase (GAD), islet antigen 2 (IA-2), and insulin autoantibodies
Diabetomics obtains CE-IVD Mark on glutamic acid decarboxylase (GAD), islet antigen 2 (IA-2) and insulin autoantibody point-of care tests for rapid assessment of type 1 diabetes and latent autoimmune diabetes in adults (LADA). Rapid point-of-care test for determination of C-peptide levels. Diabetomics obtains CE-IVD Mark for rapid-point-of care (POC) test for C-peptide estimation. The availability …
FDA issues Emergency Use Authorization for the oral fluid rapid test for SARS-CoV-2 antibodies, the CovAbTM SARS-CoV-2 Ab Test
On June 4, 2021 the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of CovAb SARS-CoV-2 Ab Test pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). Device: CovAb SARS-CoV-2 Ab Test EUA Number: EUA210017 Company: Diabetomics, Inc. Indication: Qualitative detection of total …
Publication of Rapid Point-of-Care Test for Determination of C-Peptide Levels
Diabetomics developed the first rapid point-of-care test for C-peptide estimation. The Insudex® C-peptide POC test has a wide dynamic range and sensitivity comparable to a laboratory-based predicate assay. The availability of a rapid, simple-to-use POC test for C-peptide will facilitate staging of presymptomatic T1D and differential diagnosis of late-onset T1D, LADA, and MODY. Rao et al. Journal …
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Regulatory approvals
Insudex GAD65 point-of care test for rapid assessment of GAD65 autoantibodies is CE marked.
A Landmark Lumella Preeclampsia point-of-care test study published in British Journal of Obstetrics & Gynecology.
A large, independent and prospective study in a low-resource setting demonstrated Lumella Preeclampsia rapid point-of-care test clinical utility for diagnosis of preeclampsia. Glycosylated fibronectin point-of-care test for diagnosis of pre-eclampsia in a low-resource setting: a prospective Southeast Asian population study
Publication of Lumella Preeclampsia test for short-term prediction of preeclampsia.
The study shows Lumella PE test has the best performance for short-term prediction of preeclampsia in 1-4 weeks.Huhn et al. BMC Pregnancy and Childbirth (2020) 20:128 Maternal serum glycosylated fibronectin as a short-term predictor of preeclampsia: a prospective cohort study