Exagen Inc., Allegheny Health Network Research Institute, and AHN Autoimmunity Institute Announce Collaboration to Develop Novel Patented Biomarkers into Clinical Diagnostic Tests

The suite of innovative biomarker assays seeks to further aid clinicians in the diagnosis, prognosis and monitoring of patients with autoimmune diseases

SAN DIEGO, May 04, 2021 (GLOBE NEWSWIRE) — Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, Allegheny Health Network (AHN) Research Institute and the AHN Autoimmunity Institute jointly announced today the execution of a research collaboration agreement and an exclusive license agreement. The collaboration will focus on the development of novel patented biomarkers for diagnosis, prognosis and monitoring of autoimmune diseases, including systemic lupus erythematosus (SLE).

Under the terms of the research collaboration and license agreement, Exagen will acquire a worldwide exclusive license to four distinct families of inventions from the laboratory of Joseph Ahearn, MD, and Susan Manzi, MD, MPH, in addition to access to the Autoimmunity Institute’s extensive and well-characterized clinical biobank.

The parties will mutually invest in the collaborative development of the patents, leading to the development and commercialization of a suite of novel biomarker assays that were developed using a specialized technology known as CB-CAPs or ‘Cell-Bound Complement Activation Products.’ The new assays will augment the use of CB-CAPs that similarly power Exagen’s AVISE® testing which Dr. Ahearn and Dr. Manzi helped design and that became commercially available in 2012. The testing aids clinicians by adding clarity to the clinical evaluation of suspected autoimmune patients that may have lupus.

Dr. Ahearn, Chair of the AHN Autoimmunity Institute stated, “We are delighted to partner with Exagen, a leader in autoimmune testing solutions, to further develop our novel patented biomarkers into new clinical diagnostic assays.” Dr. Manzi, Chair of the AHN Medicine Institute and Director of its Lupus Center of Excellence added, “We look forward to working with Exagen to further diversify the deployment of CB-CAPs in their AVISE testing products to better support patients with lupus and related autoimmune diseases.”

Established in 2018, the AHN Autoimmunity Institute is focused on advancing the diagnosis, treatment, prevention and cure of all autoimmune diseases through collaborative multi-specialty care, cutting-edge research, advocacy and education. The Institute is a national referral center offering multi-disciplinary, coordinated care for patients with one or more complex autoimmune conditions.

“We are excited to once again work with Dr. Ahearn, Dr. Manzi and the AHN Autoimmunity Institute to accelerate development of their highly-innovative biomarker assays to better serve patients with autoimmune disorders and address the disparity in medical treatment of women and people of color. Dr. Ahearn and Dr. Manzi are both well-respected pioneers in the field of autoimmune research, and Exagen is eager to collaborate with them to bring exciting and impactful products forward to improve the care continuum for patients,” said Ron Rocca, President and CEO of Exagen Inc.

About Exagen Inc. 

Exagen is dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases by enabling timely differential diagnosis and optimizing therapeutic intervention. Exagen has developed and is commercializing a portfolio of innovative testing products under its AVISE® brand, several of which are based on our proprietary Cell-Bound Complement Activation Products, or CB-CAPs, technology. Exagen’s goal is to enable providers to improve care for patients through the differential diagnosis, prognosis and monitoring of complex autoimmune and autoimmune-related diseases, including rheumatoid arthritis and lupus. For further information please visit www.exagen.com.

About Allegheny Health Network

Allegheny Health Network (AHN.org), a Highmark Health company, is an integrated healthcare delivery system serving the greater Western Pennsylvania region. The Network is composed of 13 hospitals, ambulatory surgery centers, Health + Wellness Pavilions, an employed physician organization, home and community-based health services, a research institute and a group purchasing organization. The Network provides patients with access to a complete spectrum of advanced medical services, including nationally recognized programs for primary and emergency care, cardiovascular disease, cancer care, orthopedic surgery, neurology and neurosurgery, women’s health, autoimmune diseases, diabetes and more. AHN employs approximately 21,000 people, has more than 2,600 physicians on its medical staff and serves as a clinical campus for Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.

Forward Looking Statements

Exagen cautions you that statements in this press release that are not a description of historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the expected benefits of the collaboration with the Allegheny-Singer Research Institute and the Allegheny Health Network and any development and commercialization of novel patented biomarkers for diagnosis, prognosis and monitoring of autoimmune diseases. The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Exagen’s business, including, without limitation: developing new biomarkers assays involves a lengthy and complex process, and the collaboration may not lead to novel patented biomarkers or generate significant commercial testing products on a timely basis, or at all; the COVID-19 pandemic may adversely affect our business, financial condition and results of operations, including our collaboration and development activities; risks associated with maintaining the collaboration and license agreement; and other risks described in the company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Exagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Westwicke Partners
Mike Cavanaugh

Exagen Inc.
Kamal Adawi, Chief Financial Officer

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Source: Exagen Inc.