Descrizione: Our Story Since 2006, Spectrum Solutions has been a single-source provider of high-quality, direct-to-consumer product innovation & global fulfillment. For the last decade, Spectrum has found a specialized focus in the medical science sector that includes the engineering and manufacturing of industry innovating medical devices. Spectrum’s innovation has made such an impact within the life science sector it has been honored with several prestigious awards, received incredible industry and private sector recognition, and is directly responsible for the birth of a new billion-dollar saliva diagnostic industry. We engineer and have medical device contract manufacturing, actively participate in medical science research programs, develop, and license diagnostic testing assays, we are uniquely able to offer our contract manufacturing and MedTech outsourcing customers measurable process optimization, a shorter time to market window, unmatched scalability, and full product development-to-delivery solutions. Sometimes a fresh perspective on something we thought we understood, can open the door of new possibilities we hadn’t even considered. Focused on pioneering medical device innovation, Spectrum Solutions commissioned the breakthrough saliva study that dared to suggest a complete transformation in viral PCR testing protocols to an easier, pain-free, non-invasive, 99.998% accurate, and infinitely safer option using saliva (spit). Saliva’s recent MVP status is a new development even though saliva’s been used in diagnostics for more than 2000 years. Analysis of the properties in saliva using biochemical and physiological methodologies are traced back to at least a century ago. Unlike blood, saliva analysis looks at the cellular level (the biologically active compounds), making it a better representative of what is clinically relevant. Years from now, the medical community, patients, and history books will look back on 2020 and COVID-19 testing as the diagnostic turning point in favor of saliva. In affirmation of this diagnostic innovation pivot, a speedy and unprecedented FDA response secured the first Emergency Use Authorization (EUA) early March 2020, for the use of saliva, solely collected using the Spectrum SDNA-1000, as a diagnostic biomaterial for COVID-19 testing. A few weeks later, requests for additional product and process information to further validate safety and sample efficacy in extended storage and transport scenarios. The device’s remarkable performance locked in the FDA’s first direct-to-patient at-home testing authorization for the self-collection of saliva. A timely decision that drove product integration both nationwide and globally. Saliva collected using a Spectrum bio-sample collection system creates the most robust and safest testing biomaterial. We believe when you bridge the gap between science and real medical solutions you deliver innovation with the practical power to impact and change outcomes. Our products, services, and expertise are paving the way and pioneering a new era of direct-to-consumer health & wellness, point-of-care, and at-home molecular diagnostic testing.

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Vittima localizzata in: USA

Sito web: https://spectrumsolution.com/

Settore lavorativo: Health