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Intelligent Bio Solutions | 8-K: Current report

Intelligent Bio Solutions | 8-K: Current report

Intelligent Bio Solutions | 8-K:重大事件
美股SEC公告 ·  2024/09/06 05:18

牛牛AI助理已提取核心訊息

Intelligent Bio Solutions has made significant progress in its FDA 510(k) submission process, completing approximately one-third of subject enrollment for its method comparison study. The study, conducted in partnership with CenExel, aims to recruit 135 healthy adults across three sites to compare fingerprint sweat opiate screening tests with LC-MS/MS laboratory methods.The company has also completed the in-clinic portion of a pharmacokinetic study on opiates in human fingerprint sweat, with specimen and data analysis currently underway. According to CEO Harry Simeonidis, the company remains on track to complete the in-clinic portion of the method comparison study by September end, targeting FDA 510(k) submission in Q4 2024.The clinical studies aim to demonstrate the effectiveness and accuracy of the Intelligent Fingerprinting Drug Screening System, which offers rapid, non-invasive drug testing through fingerprint sweat analysis. The system is designed to detect common workplace drugs including opiates, cocaine, methamphetamine, and cannabis, with results available in under ten minutes.
Intelligent Bio Solutions has made significant progress in its FDA 510(k) submission process, completing approximately one-third of subject enrollment for its method comparison study. The study, conducted in partnership with CenExel, aims to recruit 135 healthy adults across three sites to compare fingerprint sweat opiate screening tests with LC-MS/MS laboratory methods.The company has also completed the in-clinic portion of a pharmacokinetic study on opiates in human fingerprint sweat, with specimen and data analysis currently underway. According to CEO Harry Simeonidis, the company remains on track to complete the in-clinic portion of the method comparison study by September end, targeting FDA 510(k) submission in Q4 2024.The clinical studies aim to demonstrate the effectiveness and accuracy of the Intelligent Fingerprinting Drug Screening System, which offers rapid, non-invasive drug testing through fingerprint sweat analysis. The system is designed to detect common workplace drugs including opiates, cocaine, methamphetamine, and cannabis, with results available in under ten minutes.
智能生物解決方案在其FDA 510(k)提交過程中取得了重大進展,已完成大約三分之一的受試者入組,進行其方法比較研究。該研究與CenExel合作進行,旨在在三個地點招募135名健康成年人,將指紋汗液中的鴉片篩查測試與LC-MS/MS實驗室方法進行比較。該公司還完成了對人類指紋汗液中鴉片的藥代動力學研究的臨牀部分,目前正在進行樣本和數據分析。根據首席執行官Harry Simeonidis的說法,該公司仍然按計劃在九月底前完成方法比較研究的臨牀部分,目標是在2024年第四季度提交FDA 510(k)。臨牀研究的目的是證明智能指紋藥物篩查系統的有效性和準確性,該系統通過指紋汗液分析提供快速、非侵入性的藥物檢測。該系統旨在檢測包括鴉片、可卡因、甲基苯丙胺和大麻股等常見工作場所藥物,結果在十分鐘內可獲得。
智能生物解決方案在其FDA 510(k)提交過程中取得了重大進展,已完成大約三分之一的受試者入組,進行其方法比較研究。該研究與CenExel合作進行,旨在在三個地點招募135名健康成年人,將指紋汗液中的鴉片篩查測試與LC-MS/MS實驗室方法進行比較。該公司還完成了對人類指紋汗液中鴉片的藥代動力學研究的臨牀部分,目前正在進行樣本和數據分析。根據首席執行官Harry Simeonidis的說法,該公司仍然按計劃在九月底前完成方法比較研究的臨牀部分,目標是在2024年第四季度提交FDA 510(k)。臨牀研究的目的是證明智能指紋藥物篩查系統的有效性和準確性,該系統通過指紋汗液分析提供快速、非侵入性的藥物檢測。該系統旨在檢測包括鴉片、可卡因、甲基苯丙胺和大麻股等常見工作場所藥物,結果在十分鐘內可獲得。

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