2020年12月21日

Stemina的人類細胞devTOX quickPredict分析能夠預測發育毒性的潛力含有尼古丁產品新研究發表在科學雜誌目前在毒理學研究細胞devTOX quickPredict分析預測發育毒性。新的研究支持的效用devTOX quickPredict (devTOXqP)人類誘導多能幹細胞(iPS)的分析從Stemina生物標誌物的發現(Stemina)作為第一個人性化體外試驗有效地預測風險引起的胚胎發育早期化學接觸,包括從含有尼古丁的產品。這項新研究中,“人類誘導多能幹細胞的使用屏幕發育毒性潛在表明減少non-combusted潛力產品,與香煙相比,“本周發表在《現代毒理學研究的科學家Stemina生物標誌物的發現,公司在這個研究中,各種含有尼古丁的產品——包括香煙、激烈的煙草製品,無煙電子香煙(電子煙)進行了測試。試驗結果預測,氣溶膠參考香煙和激烈的煙草產品(HTP)被困在磷酸緩衝鹽(PBS)提供了巨大的潛在風險早期發育毒性,主要通過細胞毒性化合物除了尼古丁,而從一個混合tobacco-flavored煙和非香煙包含電子煙沒有預測存在同樣的風險分析。Stemina devTOXqP是代謝組學biomarker-based測試評估基於iPS細胞的發育毒性的潛在改變比例的關鍵生物標誌物,鳥氨酸、胱氨酸(o / c)。在這項研究中,煙霧和氣溶膠從測試文章通入磷酸緩衝鹽(PBS)。“誘導多能性”細胞暴露在8充溢PBS (bpb)的濃度。試驗敏感性評估通過與一個已知的強化研究發育毒物all-trans24視黃酸(ATRA)。伊麗莎白唐利、法學博士、MBA、女士Stemina首席執行官評論說:“這是一個嚴重的需要快速,節省成本,大規模篩選化驗以更大的相關性比當前人類動物性測試。從方法論的角度來看,也有越來越多的監管這個特定的端點,興趣和新分析能夠評估發育毒性是必需的。 The development and subsequent successful assessment of devTOX quickPredict against a variety of nicotine-containing products represents an important step in demonstrating proof-of-concept for this human-based test.” Until recently, assessing the potential toxicity of such products has required the use of in vivo animal testing. However, animal testing is costly, time-consuming, and often poorly predictive of toxicity in humans. Additionally, several European Union member states have banned the use of animal testing in assessing the relative toxicity of tobacco-related products. “While no single in vitro toxicology assay can cover the entire cycle of embryonic development, the results of this research suggest considerable value for devTOXqP as a rapid, cost-effective test for use in screening the potential toxicity of e-cigarettes and other non-combustible nicotine products,” commented Jessica Palmer, MS, Associate Director of Toxicology at Stemina and co-author on the study. The devTOXqP platform has been successfully used by the U.S. Environmental Protection Agency (EPA) to support their ToxCast and Virtual Tissue Model programs. As part of the EPA’s ToxCast Initiative, 1065 phase I and II compounds have been screened in the devTOXqP assay. Within the screened compounds, 19% were predicted to have the potential to cause developmental toxicity, and when compared to in vivo models, the assay had a 79% to 82% accuracy. Donley concluded, “As the greater use of in vitro assays based on human-derived cells is one of the aims of “Toxicity Testing in the 21st Century,” designed to lead to the reduced use or ultimate replacement of animal testing, we are working with the U.S. EPA and the U.S. Food and Drug Administration (FDA) to embed devTOXqP as a recommended assay in nicotine product safety evaluations.” Source: Company Press Release