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Lupus
DxTerity receives NY authorization for SLE test
The DxTerity test is designed for patients with systemic lupus erythema (SLE), which affects up to one million patients in the U.S.
September 15, 2022
Exagen highlights lupus diagnosis study
The trial, called Complement Activation Products vs. Standard ANA Testing: Treatment Outcomes, Diagnosis, and Economic Impact in Systemic Lupus Erythematosus (CAPSTONE), utilized multiple external databases and nearly 50,000 patient tests conducted with either Avise or standard-of-care labs.
July 4, 2022
DxTerity Diagnostics launches gene expression test for lupus
IFN-1 is a key biomarker and important indicator of lupus severity and prognosis, the firm said, adding that high IFN-1 levels are linked to increased risk of disease severity and development of lupus nephritis.
June 9, 2022
FDA clears Thermo Fisher autoimmune disease tests
The Waltham, MA-based firm said EliA RNA Pol III is the first fully automated RNA polymerase test for systemic sclerosis available in the U.S. Its EliA Rib-P test can be used to support the diagnosis of systemic lupus erythematosus, particularly in antinuclear antibody-negative patients.
June 8, 2022
FDA clears Thermo Fisher's new blood test for lupus
The EliA SmDP-S Test is designed to reduce the number of false-positive results and provide improved diagnostic guidance for SLE. The new test enhances specificity without sacrificing sensitivity, Thermo Fisher said.
August 25, 2021
Fujifilm Medical to add IVD to portfolio
Fujifilm Wako Diagnostics has developed biomarkers that assess the risk of hepatocellular carcinoma in patients with chronic liver disease, as well as IVD reagents for disorders of lipid metabolism, lupus, rheumatoid arthritis, coronary heart disease, and diabetes, according to Fujifilm Medical Systems.
August 16, 2020
DxTerity launches interferon test for lupus
Lupus is a heterogeneous disease, which has presented hurdles for conducting drug trials and developing new treatments. Consequently, biomarker development is critical. The company reported that in a longitudinal study with the Oklahoma Medical Research Foundation, there was a highly significant statistical association between type 1 interferon status and risk for developing lupus. DxTerity noted that its test is already being used in clinical trials of lupus.
November 7, 2019
Progentec wins NIH grant for lupus blood tests
The NIH's National Institute of Allergy and Infectious Diseases is awarding the financing to the Oklahoma City-based company through the U.S. government's Small Business Innovation Research (SBIR) program. The aim is to develop tests that will help overcome the limitations of currently available clinical tools, such as the SLE Disease Activity Index 2000 (SLEDAI-2K).
July 28, 2019
Single-cell sequencing supplies clues about managing lupus
The study of tissue samples from renal biopsies of 21 patients, with skin punch biopsy specimens also available for 17 patients, showed that interferon (IFN) response scores as assessed with single-cell sequencing technology were elevated in tubular cells and keratinocytes from patients with lupus nephritis (LN), compared with healthy controls. Lupus nephritis is a common and debilitating condition involving kidney inflammation in patients with systemic lupus erythematosus (SLE).
May 20, 2019
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