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Salivary Bioscience News

Salimetrics Expands Laboratory CLIA Certification for Saliva Testing

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(February 2, 2022)

Saliva testing is gaining in its utility to provide screening and diagnostic solutions, and Salimetrics is here to meet the needs of this growing field. With the recent expansion of Salimetrics’ CLIA certification, the Saliva Laboratory reaches a new milestone in salivary bioscience. Salimetrics Saliva Laboratory’s experienced team, combined with the expanded CLIA and BSL-2 compliant facility, leverages the highest quality standard available for saliva analysis.

Over the last two years, researchers have successfully translated the science of saliva into groundbreaking diagnostic tools. Alongside them, Salimetrics has expanded their CLIA certification for the Salimetrics Laboratory. “Partnering with Salimetrics ensures that the science of saliva is always operating within the methods that maintain the highest scientific credibility and standards,” says Steve Granger, Ph.D., Salimetrics Chief Scientific Officer. “Not only does Salimetrics operate the most qualified saliva testing laboratory, we also offer comprehensive scientific advice and a range of laboratory-based analysis to industry partners.”

The expansion of Salimetrics’ CLIA certification enables the Salimetrics Laboratory to receive samples from every state in the USA for high complexity testing, except for New York. However, Salimetrics also maintains partnerships with testing labs in New York that can further enable saliva-based CLIA-certified testing when needed. This expansion also provides a Laboratory Developed Test (LDT) mechanism, where Salimetrics can rapidly respond to industry needs for saliva testing in regulatory environments.

With the Saliva Laboratory’s CLIA certification expansion, Salimetrics also welcomes a new Laboratory Director, Benjamin Gerson, M.D., to the team. Dr. Gerson specializes in Epidemiology, Medical Devices, Oncology, Toxicology, Sleep Disorders, Biotechnology, and Health Services & Research. Dr. Gerson attributes a broad array of expertise to the Salimetrics Laboratory team due to his extensive background, and as an experienced medical professional, shares a demonstrated history of working in the hospital and health care industry. He is a graduate of the Jefferson Medical College, Thomas Jefferson University, and is involved with the National Sleep Foundation, the Medical Review Officers Certification Council (MROCC), Sleep Inc., the Opioid Advisory Committee of the American Academy of Pain Medicine, and the National Safety Council. He has been an associate professor at Harvard Medical School, full professor at Boston University School of Medicine, and adjunct professor at Thomas Jefferson Medical College. Dr. Gerson is certified by and is a member of the Board of Directors of MROCC, which certifies MROs.

The Clinical Laboratory Improvement Amendments (CLIA) were passed by Congress in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. While Salimetrics has maintained a CLIA certified lab since 2001, the recent increase in clinically focused saliva testing has driven Salimetrics to increase the ability to support this need. Saliva has always maintained the diagnostic viability to enable complex sampling schedules and home collection via contactless healthcare, such as telehealth or remote office visits while employing a level of flexibility that supports successful solutions for precision medicine. Salimetrics continues to support these efforts by focusing on better methods for the proper collection, handling, transport, and testing of quality samples. This includes implementing the infrastructure necessary to support current and future saliva-based diagnostics and requires sufficient groundwork to leverage easy, safe, and economical sampling. “The Salimetrics team has been hard at work designing a workflow that provides end-to-end solutions for patient saliva collection and transport to the Salimetrics Laboratory. This workflow includes a complete, pre-designed sample collection kit, easy-to-use sample collection devices, cold-chain managed return shipping to the Salimetrics Saliva Laboratory, and a complete, HIPAA compliant results reporting system,” says Dr. Granger.

Experts at Salimetrics Laboratory have years of experience and specialized training in the proper liquid handling, storage, and assay techniques necessary to process saliva as a biological sample. The clinical-level quality standard at the Salimetrics Saliva Laboratory will continue to complement clinical and research studies that require precise and accurate characterizing of salivary biomarker concentrations and analyte activity. Saliva assays can also provide the critical, non-invasive feedback necessary to ensure clinical significance and efficacy in cost-effective doses. “We are happy to provide investigators access to expanded analytical testing services both in the USA and this same level of quality control and testing to investigators around the world,” said Dr. Granger. “As the diagnostic utility of salivary bioscience expands to new heights, our ability to harness and implement better methods will continue to be a vital cornerstone in the growth of the salivary bioscience community and the people it serves.”

To discuss your project or learn more about Salimetrics Laboratory Services, visit the Salimetrics Website or Ask An Expert.

About Salimetrics

Salimetrics’ assay kits and CLIA-certified testing services are used to measure salivary analytes related to stress, behavior and development, inflammation, sleep, reproduction, health, and immune function. Founded in 1998 by Douglas A. Granger, Ph.D., Salimetrics, LLC support CROs, pharmaceuticals, academic researchers, and the immunodiagnostic industry around the world with innovative immunoassay products, non-invasive saliva collection methods, and laboratory testing services.

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*Note: Salimetrics provides this information for research use only (RUO). Information is not provided to promote off-label use of medical devices. Please consult the full-text article.

Contact: Salimetrics (USA)
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