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Archive - Aug 6, 2017

Exosome Diagnostics Achieves ISO 13485 Certification Its USA and Germany Facilities; Company Growing into IVD Manufacturer Due to Demand for Its Instrument Platform & Companion Diagnostic Tests

On August 3, 2017, Exosome Diagnostics, Inc., a leader in the liquid biopsy market, announced that it has received ISO 13485 certification for both its USA and Germany facilities. This achievement paves the way for the company to be an In Vitro Diagnostic (IVD) medical device design and manufacturing organization. Combined with the company’s CLIA-certified Waltham, Massachusetts laboratory and ISO 15189-accredited Munich laboratory, the IVD-certified locations will serve as an integral part of the company’s strategy for the instrument platform, companion diagnostics, and diagnostics to better the lives of patients worldwide. The British Standards Institution (BSI) has certified Exosome Diagnostics under ISO 13485:2003 under CMDCAS for the following scope: “Design, development, manufacture, distribution, installation, and service of In Vitro Diagnostic (IVD) medical devices including opto-electromechanical instruments, sample collection kits, reagents, and disposables.” As defined by the International Organization for Standardization, ISO 13485 is a standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices (IVDs) and related services that consistently meet customer needs and applicable regulatory requirements. “This ISO 13485 certification is a testament to the compliance initiatives undertaken by Exosome Dx to design and manufacture IVDs. Working closely with the notified body and appropriate regulatory agencies, Exosome Dx adheres to the strictest standards to provide the highest quality of products to clinicians,” stated Raaj Venkatesan, Head of Regulatory Affairs at Exosome Diagnostics.

“The Biology of Color”—New Study Explores Advances and Challenges in Field of Animal Coloration

Scientists are on a threshold of a new era of color science due largely to an explosion of technologies, but key questions remain for the field, according to a study published in the August 4, 2017 issue of Science by an international team of researchers led by Dr. Tim Caro of the University of California (UC), Davis. While studies have long used color as a factor for understanding evolution, only recently have visual physiologists, sensory and behavioral ecologists, evolutionary biologists, and anthropologists come together to study how color is produced and perceived by animals and its function and patterns of evolution. With this wide-ranging synthesis in Science, entitled "The Biology of Color," such a multidisciplinary group provides a roadmap of advances in the field of animal coloration, as well as citing remaining challenges. "In the past 20 years, the field of animal coloration research has been propelled forward very rapidly by technological advances," said corresponding author Dr. Caro, a professor in the UC Davis Department of Wildlife, Fish and Conservation Biology. "These include digital imaging, innovative laboratory and field studies, and large-scale comparative analyses, each of which is allowing completely new questions to be asked." Coloration is a complicated biological trait. Animals use it for camouflage, to send warning signals, attract mates, send social signals, regulate their body temperature, and thwart pests, among other uses. Dr. Caro's own research has helped clarify long-held mysteries about animal coloration. This includes why zebras have black and white stripes (to avoid biting flies) (https://www.ucdavis.edu/news/wildlife-biologist-earns-his-zebra-stripes-...) and why pandas are black and white (to provide camouflage in both snow and dark forests, because they need to eat year-round).