Augurex and New Day Diagnostics Announce Launch of Anti-14-3-3eta Multiplex Analyte Specific Reagents; Enabling a First-In-Class Diagnostic Test for Axial Spondyloarthritis

• Augurex launches Anti-14-3-3eta Multiplex Analyte Specific Reagents (ASRs), supporting the development of a first-in-class diagnostic test for axial spondyloarthritis (axSpA) by New Day Diagnostics.
• The new laboratory developed test, which uses Anti-14-3-3eta Multiplex ASRs as components, aims to reduce the extensive diagnostic delay typically experienced by axSpA patients, provide clinicians with a reliable tool to help improve patient outcomes, and potentially aid the early diagnosis and treatment of axSpA.

VANCOUVER, British Columbia & KNOXVILLE, Tenn.--(BUSINESS WIRE)--Augurex Life Sciences Corp. (“Augurex”) today announced the launch of Anti-14-3-3eta Multiplex Analyte Specific Reagents (ASRs), supporting the development of a first-in-class diagnostic test that assists clinicians in the diagnosis of axial spondyloarthritis (axSpA). New Day Diagnostics in Knoxville, TN, developed the diagnostic test using the Anti-14-3-3eta Multiplex ASRs as components and now offers the test through physician order only. This novel diagnostic test is designed to empower clinicians to identify axSpA at an earlier stage, potentially addressing the often-lengthy diagnostic delay and improving outcomes for patients.

AxSpA is a debilitating form of inflammatory arthritis that targets the spine and sacroiliac joints, frequently causing chronic pain, spinal damage and mobility issues. Despite its profound impact, axSpA patients have faced an average diagnostic delay of 7 to 10 years. This extensive delay is due in part to the absence of reliable biomarkers detectable through diagnostic testing techniques, often relying on costly imaging procedures that aren’t accessible to all. Early diagnosis is essential as it enables timely intervention that can slow disease progression, preserve mobility, and significantly improve patient outcomes. Anti-14-3-3eta Multiplex ASRs help clinical laboratories detect Anti-14-3-3eta autoantibodies; biomarkers indicative of certain autoimmune disorders such as axSpA. Diagnostic tests for axSpA using the Anti-14-3-3eta Multiplex ASRs aim to address the critical need of axSpA patients by equipping clinicians with essential tools to aid in the early diagnosis of axSpA, enabling timely treatment.

“The availability of the Anti-14-3-3eta Multiplex ASRs for axSpA marks a significant advancement in diagnostics and has enabled the development of novel laboratory developed tests,” said Eric Mayer, President and CEO of New Day Diagnostics. “Our test, which uses Augurex’s ASRs as components, provides clinicians with an accessible and reliable tool for identifying a condition that is often missed, helping patients receive targeted care earlier.”

Neil Klompas, CEO of Augurex, emphasized the importance of this new diagnostic tool, saying, “The launch of Anti-14-3-3eta Multiplex ASRs represents an important first step in enabling new diagnostic options for axSpA patients in the United States. We are committed to expanding access to this important advance in autoimmune diagnostics, with the goal of decreasing diagnostic delays in this potentially debilitating autoimmune condition and ultimately driving improved health outcomes.”

New Day Diagnostics in Knoxville, TN, is making its first-in-class diagnostic test for axSpA using Augurex’s Anti-14-3-3eta Multiplex ASRs accessible to clinicians across the United States. This launch marks a milestone in delivering timely, biomarker-based solutions for axSpA, underscoring the collaborative efforts between Augurex and New Day Diagnostics, announced in May 2024. Nationwide access to additional laboratory developed tests that include Augurex’s Anti-14-3-3eta Multiplex ASRs as components through leading clinical laboratories across the United States is anticipated in 2025, paving the way for broader availability and to further advancing improved outcomes for axSpA patients.

About Augurex

Augurex is a commercial stage diagnostics company dedicated to the early identification and diagnosis of autoimmune disorders, allowing treatment options to be optimized and personalized for patients around the world. Augurex’s lead diagnostic test which detects the 14-3-3eta protein, available as JOINTstat® in Canada, is an important tool in the diagnosis and management of inflammatory diseases, including rheumatoid arthritis. The analyte specific reagents to detect 14-3-3eta are available for purchase and use by U.S. clinical laboratories as a component of diagnostic tests developed by such laboratories. The Anti-14-3-3eta Multiplex ASRs expand Augurex’s biomarker-informed diagnostic autoimmune solutions into axial spondyloarthritis, an autoimmune disease often misdiagnosed as low back pain, and which if untreated can lead to impaired spinal mobility and fusion of the vertebrae. Learn more about Augurex at www.augurex.com and follow us on Facebook, LinkedIn and X.

About New Day Diagnostics, LLC

New Day is a pioneering healthcare company dedicated to transforming the landscape of diagnostics and research. Through our two divisions, New Day Diagnostics and New Day Bioresearch, we deliver innovative solutions that empower individuals and healthcare providers alike. New Day Diagnostics is at the forefront of developing cutting-edge diagnostic products and lab tests, including our flagship blood-based cancer screening tests ColoHealth™ and the next-generation ColoPlex Plus™, while New Day Bioresearch offers white-glove contract research services to accelerate the development and regulatory approval of groundbreaking diagnostic tests and devices. With a commitment to quality, innovation, and patient-centered access and affordability, New Day bridges the gap between the lab, bedside, and home, making health information more accessible and improving outcomes worldwide.