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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™ is a 92-gene expression assay capable of classifying
39 tumor types. CancerTYPE ID™ 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™ (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™ 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™, and its H/I™ (HOXB13/IL17BR) test to assess risk of
recurrence and response to endocrine therapy in certain breast cancer
patients.
CONTACT:
Antonius Schuh, Ph.D., Chief Executive Officer of AviaraDx, Inc.
+1 (760) 579 0500
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