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Immunovia, Inc. Laboratory Receives Accreditation from College of American Pathologists – a major step in the nationwide US roll-out of IMMray™ PanCan-d

March 8, 2022

LUND, SWEDEN  The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Immunovia, Inc. in Marlborough, Massachusetts, based on the positive results of a recent onsite inspection as part of the CAP’s Accreditation Programs.

Philipp Mathieu, Immunovia’s Acting CEO, commented “This is an exciting day for Immunovia, since CAP accreditation not only signifies the highest quality standards of our laboratory, it also allows us to seek licensure in the 5 remaining US states, allowing us to roll out the IMMray™ PanCan-d test to individuals in all 50 states, including California and New York, in the near future, further advancing our mission to make early detection of pancreatic cancer broadly available.”

The College of American Pathologists congratulated Thomas C. King, MD, PhD, Medical Director of Immunovia, Inc. for the excellence of the services being provided and advised him of this national recognition. Immunovia, Inc. is now one of more than 8,000 CAP-accredited facilities worldwide.

“This is a huge milestone for the company, as it further solidifies the quality of our laboratory and the services we provide to physicians and their patients at high risk for developing pancreatic cancer with the IMMray™ PanCan-d test” states Dr. Thomas King.

The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal-to or more-stringent-than the government’s own inspection program.

During the CAP accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory’s records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management.

For more information, please contact:
Philipp Mathieu
Acting CEO and President
Email: philipp.mathieu@immunovia.com

Tobias Bülow
Senior Director Investor Relations and Corporate Communications
Email: tobias.bulow@immunovia.com
Tel: +46 736 36 35 74

The information was submitted for publication on March 8, 2022, at 12:30 pm CET.

About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP Annual Report at cap.org. 

About Immunovia
Immunovia AB is a diagnostic company with the vision to revolutionize blood-based diagnostics and increase survival rates for patients with cancer.

Our first product, IMMray™ PanCan-d is the only blood test currently available specifically for the early detection of pancreatic cancer. The test has unmatched clinical performance. Commercialization of IMMray™ PanCan-d started in August 2021 in the USA and IMMray™ PanCan-d is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information see: www.immunoviainc.com.

Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups globally to make this test available to all high-risk pancreatic cancer groups.

The USA, the first market in which IMMray™ PanCan-d is commercially available, is the world’s largest market for the detection of pancreatic cancer with an estimated value of more than USD 4 billion annually.

Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.

Press release (PDF)