KCAS Bioanalytical and Biomarker Services Now Offers Ultra-Sensitive Validated Assay for Nicotine Studies

KCAS has entered the market to provide bioanalytical services to both tobacco and e-cigarette companies to help them meet the timelines mandated by the FDA.

KCAS Bioanalytical and Biomarker Services, a leading functional service contract research organization (CRO) has validated a 0.2 ng/mL lower limit (LLOQ) assay for nicotine and two key metabolites cotinine and trans-3’-hydroxycotinine in plasma. Previously having validated a 0.5 ng/mL LLOQ assay, the ultra-low trace nicotine assay meets additional needs of tobacco industry that need to detect trace levels to evaluate risk of tobacco products in development.

Sample contamination from the environment presents a major concern since nicotine is ubiquitous. To be able to accomplish the assay sensitivity, KCAS customized a secondary location lab space on a smoke-free campus approximately 15 minutes from our Headquarters. This permits lowering the background levels of nicotine to trace levels. “The ability to quickly respond to industry’s growing needs for this service is further evidence of KCAS’ commitment to investment in capabilities and expertise,” stated John Bucksath CEO. “Our recent expansion of a new laboratory site and increasing our team of experts has positioned KCAS well to serve customers in this space.”

KCAS has formed clinical partnerships that have established relationships with both tobacco and e-cigarettes companies to provide clients with a one-stop shop to alleviate bottleneck issues resulting from an insufficient capacity and ability of labs able to validate these assays and measure nicotine at low levels without ongoing contamination. Time is of critical importance to clients. The FDA’s Center for Tobacco Research (CTR) has mandated every product on…

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