New Day Diagnostics Collaboration
Augurex and New Day Diagnostics Collaborate to Launch SPINEstat™, Revolutionizing Early Diagnosis and Management of Ankylosing Spondylitis
Augurex and New Day Diagnostics Collaborate to Launch SPINEstat™, Revolutionizing Early Diagnosis and Management of Ankylosing Spondylitis
Vancouver, BC, Canada and Knoxville, TN, USA, 30 May 2024 – Augurex and New Day Diagnostics are excited to announce their collaboration to launch SPINEstat™, a first-of-its-kind multiplex biomarker assay that will transform the management of ankylosing spondylitis (AS), a debilitating form of spinal arthritis.
SPINEstat, a blood test to detect auto-antibodies to the 14-3-3η (eta) protein, together with a clinical assessment, will allow doctors to accurately differentiate AS from chronic low back pain, a common misdiagnosis. Symptoms typically start under the age of 45, being the peak-productivity years for most people, and on average, it takes 10 years for them to be diagnosed after enduring needless suffering and debilitation. Currently, there are no easily accessible blood tests for AS. A recent study showed that when SPINEstat is used alongside a common inflammation marker, C-reactive protein (CRP), 90% of people with AS are identified, enabling them to get highly effective treatment.
Dr. Walter Maksymowych1, a global leading AS expert emphasized the criticality of early AS diagnosis: “Diagnosing AS in its early stages can profoundly impact patients’ quality of life by potentially preventing irreversible spinal damage and preserving mobility. Early diagnosis is crucial to halting the disease since AS is treatable if it is caught early before spinal damage occurs, which is why a readily available, cost-effective biomarker-based blood test is essential.”
Norma Biln, CEO of Augurex, highlighted that, “The reason that SPINEstat is so groundbreaking is because these patients have no other options. Despite the availability of excellent medicines and guidelines to treat AS, the lack of diagnostic tests has patients losing a decade of quality of life. The economic impact of AS is also immense, with late diagnosis contributing to a tenfold increase in healthcare costs for these patients.”
Eric Mayer, CEO of New Day Diagnostics, expressed his enthusiasm for the collaboration: “We are excited to work with Augurex to develop and bring their novel SPINEstat test for AS to physicians. This technology aligns with our multiplex development expertise and more importantly with our company’s mission to introduce specialized, innovative, and accessible chronic disease diagnostic tests that empower individuals for improved healthcare.”
The highly anticipated launch of the SPINEstat assay for AS is slated for the second half of 2024 and will be available for physicians to order across the U.S. This collaboration leverages data published on SPINEstat in peer-reviewed journals and transitions the test to a widely utilized Luminex™ platform, accessible in most labs.
1 Professor, Clinician and Medical Scientist in the Dept. of Medicine, Division of Rheumatology at the University of Alberta. Member of the Assessment of Spondyloarthritis International Society, Spondyloarthritis Research and Treatment Network and has served as the international principal investigator of the global Classification in Axial Spondyloarthritis Inception Cohort (CLASSIC) study.
About New Day Diagnostics
New Day Diagnostics, LLC, located in Knoxville, TN is a full-service diagnostic company committed to the development of innovative diagnostic solutions that lead to improved patient outcomes while reducing healthcare costs. The company operates a Contract Research Organization (CRO) and Central Lab Services (CLS) division with the capabilities for support throughout the diagnostic process, from biomarker to discovery to product launch. It includes an ISO 13485:2016 and CLIA certified in vitro diagnostics laboratory specializing in oncology, gastrointestinal disease, infectious disease, and women’s health. The company is also in active development and distribution of affordable, state-of-the-art, multiplex, point-of-care, and over-the-counter tests that allow early detection and monitoring of disease through accuracy, ease of use, and affordability. Its flagship technologies, ColoHealth™ and ColoPlexPLUS™ are being developed to detect colorectal cancer in its earliest stages.
About Augurex
Augurex, headquartered in Vancouver, Canada is a leading biotechnology company specializing in developing and commercializing biomarkers that revolutionize patient clinical management for improved disease outcomes. Augurex’s cutting-edge blood tests and digital health solutions enable precise care and enhance clinical assessments. The company comprises highly skilled professionals with extensive experience in biomarker development and clinical validation, collaborating with top researchers to advance the management of autoimmune diseases. Focusing on the 14-3-3η (eta) biomarker portfolio, Augurex has pioneered applications in rheumatoid arthritis (RA), ankylosing spondylitis (AS), and other autoimmune conditions. Their newest blood test, detecting 14-3-3η autoantibodies, offers groundbreaking applications in managing AS, building on the innovative technology of the 14-3-3η flagship product. The 14-3-3η protein blood test is approved by Health Canada and is available through leading healthcare providers in the United States. Augurex is committed to advancing personalized clinical decision-making and improving patient lives through biomarker-driven insights.
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