On November 30, 2021 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, reported that its Advanced Biopharma Solutions (ABS) laboratory, located in Marlborough, Massachusetts, has received its Certificate of Registration from the Clinical Laboratory Improvement Amendments (CLIA) program, following the receipt of a Massachusetts Department of Public Health clinical laboratory license (Press release, Akoya Biosciences, NOV 30, 2021, View Source [SID1234596308]). This certification enables Akoya’s ABS lab to support later stage clinical trial studies with its biopharmaceutical partners.
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CLIA certification affirms that Akoya’s ABS lab processes and services operate under high quality standards and provides a framework for assay development and validation that consistently meets guidelines for accuracy, precision, specificity, sensitivity, and reproducibility. This milestone is an important step towards advancing the company’s platforms toward clinical use. It further positions Akoya Biosciences as an attractive partner for biopharmaceutical companies seeking to incorporate its ground-breaking spatial biology technologies into their clinical research, most notably in the expanding field of cancer immunotherapy.
"Securing CLIA certification for ABS demonstrates our commitment to meeting the highest quality standards," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "This is an important step in support of our effort to work with our biopharmaceutical partners to identify biomarkers that lead to better clinical decision making and improved patient outcomes."
Spatial biology, a rapidly emerging field of science, allows researchers to discover and validate biomarker signatures that map the interactions of tumor and immune cells across an entire tumor tissue section by retaining the spatial context. Published studies have demonstrated that spatial phenotypic signatures, based on Akoya’s platform, are more accurate at predicting response to immunotherapy than biomarkers currently being used in the clinic.
The certification will enable Akoya to expand its collaborations with key partners like AstraZeneca and other biopharmaceutical companies working with Akoya’s ABS Program. The goal of this program is to enable biopharma partners to leverage Akoya’s deep spatial biology expertise and technological innovations from the early stages of clinical trials, potentially, through full companion diagnostic approval.
The CLIA certification is the latest milestone in Akoya’s ongoing efforts to ensure consistency and standardization of its laboratory processes and results. Important prior milestones include a recent publication in the Journal of Immunotherapy for Cancer on the MITRE Study, demonstrating for the first time a spatial biology workflow with the throughput, accuracy and reproducibility required to serve the translational and clinical markets.