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AviaraDx Announces CAP Accreditation of Its Laboratory Operations

CARLSBAD, Calif., Oct. 1 /PRNewswire/ -- AviaraDx announced today that the company's Carlsbad, CA, CLIA laboratory operation has received its College of American Pathology (CAP) accreditation. The laboratory offers two new molecular oncology tests to hospitals and physicians across the United States.

CancerTYPE ID(TM) is a 92-gene expression assay capable of classifying 39 tumor types.

CancerTYPE ID(TM) provides a molecular classification of metastatic cancer and guides the physician in differential diagnosis and identification of the primary tumor site. When used early in the cancer classification process, CancerTYPE ID is a powerful tool to quickly determine the likely primary tumor site, focusing the selection of confirmatory immunohistological and imaging procedures.

AviaraDx' H/I(TM) (HOXB13/IL17BR) test is a molecular extension of estrogen receptor (ER) testing and represents a significant improvement when assessing a patient's risk of breast cancer recurrence and the likely benefit from endocrine therapy. The H/I(TM) test is used to stratify ER+, node-negative breast cancer patient into high and low risk of recurrence as well as to predict response to endocrine therapy. Both HOXB13 and IL17BR biomarkers are controlled by estrogen and provide novel information about estrogen signaling in ER+ breast cancer.

The AviaraDx CLIA laboratory enables clinical and research laboratories, physicians, and pharmaceutical companies to incorporate these innovative molecular oncology tests into clinical practice. "We are very excited about receiving CAP accreditation, ensuring that our new molecular oncology tests meet the highest quality standards in the clinical laboratory industry", stated Antonius Schuh, Ph.D., CEO of AviaraDx. "Our mission is to continue to bring novel molecular oncology assays to physicians and patients, which answer unmet clinical needs in cancer care."

About AviaraDx

AviaraDx discovers, develops, and commercializes new molecular diagnostic tests in oncology, enabling physicians to personalize cancer treatment through better understanding of the molecular biology underlying a patient's tumor. Our tests improve the classification of cancer, support physicians to provide their patients with a more specific prognosis or individual risk assessment, and will eventually provide information critical to predict treatment response to a given therapeutic regimen.

AviaraDx offers diagnostic tests to qualified physicians or laboratories through its certified CLIA laboratory service operations. The company's first diagnostic test offerings are based on its proprietary technologies used in molecular classification of metastatic cancer, CancerTYPE ID(TM), and its H/I(TM) (HOXB13/IL17BR) test to assess risk of recurrence and response to endocrine therapy in certain breast cancer patients.


Antonius Schuh, Ph.D.

Chief Executive Officer of AviaraDx, Inc.

+1 (760) 579 0500

SOURCE AviaraDx, Inc.
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