Genalyte Awarded ISO 13485 Medical Device Manufacturing Certification

SAN DIEGO, Jan. 24, 2018 /PRNewswire/ -- Genalyte Inc. announced today that the company received official certification for the manufacturing of medical devices from the International Organization for Standardization (ISO). The awarding of ISO 13485 certification marks a major milestone for the San Diego based biotech start-up, providing a critical industry standard for the production of medical devices to support its cloud laboratory diagnostic testing model.

“We are pleased to receive the ISO certification, the result of over a year of work as we developed and refined our quality system and manufacturing processes,” said Cary Gunn, Genalyte founder and CEO. “This is a critical step towards achieving our vision of reliable and rapid diagnostic testing in every physician office.”

Genalyte employs a cloud-based laboratory model to test and deliver high-quality, real-time diagnostic results in the doctor’s office. Results are available in approximately 15 minutes, allowing physicians to make informed diagnosis and treatment decisions while the patient is still present. Genalyte’s state of the art technology moves data--not blood--to transform the standard of care into a service that drives better outcomes, lowers the overall cost of care and improves the patient experience.

About Genalyte
Genalyte’s mission is to empower doctors and patients to make better decisions that improve outcomes, lower overall costs, and make the diagnostics experience more effective. We employ a cloud-based laboratory service to bring diagnostic testing into the physician’s office. Results are returned in approximately 15 minutes, eliminating the need for separate trips to the lab and waiting for results. For more information, please visit: www.genalyte.com.

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SOURCE Genalyte, Inc.