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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 ·  2024/11/14 06:18

牛牛AI助理已提取核心訊息

Intelligent Bio Solutions announced positive results from its Pharmacokinetic study, a crucial milestone for FDA 510(k) submission. The study successfully demonstrated that fingerprint sweat provides a reliable sample matrix for drug detection, showing quantitative data closely aligned to blood at 95% confidence level. The study involved 39 diverse subjects and compared opiate levels in fingerprint sweat with blood, oral fluid, and urine samples.The company's Intelligent Fingerprinting Drug Screening System enables rapid drug detection through fingerprint sweat analysis, with results available in under 10 minutes. The system screens for common workplace drugs including opiates, cocaine, methamphetamine, and cannabis. All specimens were analyzed using validated LC-MS/MS methodology.Upon receiving FDA 510(k) clearance, expected after submission in Q4 2024, INBS plans to launch its technology in the US market in 2025. The company aims to serve safety-critical industries including construction, mining, transportation, as well as law enforcement and drug rehabilitation sectors.
Intelligent Bio Solutions announced positive results from its Pharmacokinetic study, a crucial milestone for FDA 510(k) submission. The study successfully demonstrated that fingerprint sweat provides a reliable sample matrix for drug detection, showing quantitative data closely aligned to blood at 95% confidence level. The study involved 39 diverse subjects and compared opiate levels in fingerprint sweat with blood, oral fluid, and urine samples.The company's Intelligent Fingerprinting Drug Screening System enables rapid drug detection through fingerprint sweat analysis, with results available in under 10 minutes. The system screens for common workplace drugs including opiates, cocaine, methamphetamine, and cannabis. All specimens were analyzed using validated LC-MS/MS methodology.Upon receiving FDA 510(k) clearance, expected after submission in Q4 2024, INBS plans to launch its technology in the US market in 2025. The company aims to serve safety-critical industries including construction, mining, transportation, as well as law enforcement and drug rehabilitation sectors.
智能生物解決方案公司宣佈其藥物動力學研究取得積極成果,這是FDA 510(k)提交的重要里程碑。研究成功證明指紋汗液提供了一種可靠的藥物檢測樣本矩陣,顯示在95%的置信水平上,定量數據與血液高度一致。研究涉及39位多樣化的受試者,並比較了指紋汗液中的鴉片水平與血液、口腔液體和尿液樣本。該公司的智能指紋藥物篩查系統通過指紋汗液分析實現快速藥物檢測,結果在10分鐘內可得。該系統篩查常見的工作場所藥物,包括鴉片、可卡因、甲基苯丙胺和大麻股。所有樣本均採用經過驗證的LC-MS/MS方法進行分析。在獲得FDA 510(k)許可後,預計在2024年第四季度提交,INBS計劃於2025年在美國市場推出其科技。該公司旨在服務於對安全至關重要的行業,包括施工、採礦、交通以及執法和藥物康復部門。
智能生物解決方案公司宣佈其藥物動力學研究取得積極成果,這是FDA 510(k)提交的重要里程碑。研究成功證明指紋汗液提供了一種可靠的藥物檢測樣本矩陣,顯示在95%的置信水平上,定量數據與血液高度一致。研究涉及39位多樣化的受試者,並比較了指紋汗液中的鴉片水平與血液、口腔液體和尿液樣本。該公司的智能指紋藥物篩查系統通過指紋汗液分析實現快速藥物檢測,結果在10分鐘內可得。該系統篩查常見的工作場所藥物,包括鴉片、可卡因、甲基苯丙胺和大麻股。所有樣本均採用經過驗證的LC-MS/MS方法進行分析。在獲得FDA 510(k)許可後,預計在2024年第四季度提交,INBS計劃於2025年在美國市場推出其科技。該公司旨在服務於對安全至關重要的行業,包括施工、採礦、交通以及執法和藥物康復部門。

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