Intelligent Bio Solutions Achieves 94.1% Accuracy in Method Comparison Study, Following Positive PK Study Results
Intelligent Bio Solutions (INBS) has successfully completed its method comparison study for the Intelligent Fingerprinting Drug Screening System, achieving 94.1% accuracy, 82.2% sensitivity, and 100% specificity. The study, conducted with CenExel using 135 healthy donors and nine system operators, compared fingerprint sweat opiate screening tests with laboratory LC-MS/MS methods. This milestone, along with recent positive Pharmacokinetic study results, supports INBS's planned FDA 510(k) submission in Q4 2024. If approved, the company aims to launch its non-invasive drug screening technology in the US market in 2025.
Intelligent Bio Solutions (INBS) ha completato con successo il suo studio di confronto dei metodi per il sistema di screening delle droghe Intelligent Fingerprinting, raggiungendo un'accuratezza del 94,1%, una sensibilità dell'82,2% e una specificità del 100%. Lo studio, condotto con CenExel utilizzando 135 donatori sani e nove operatori di sistema, ha confrontato i test di screening degli oppiacei nel sudore delle impronte digitali con i metodi di laboratorio LC-MS/MS. Questo traguardo, insieme ai recenti risultati positivi dello studio di farmacocinetica, supporta la pianificazione da parte di INBS della sottomissione 510(k) alla FDA nel quarto trimestre del 2024. Se approvata, l'azienda intende lanciare la sua tecnologia di screening per droghe non invasiva nel mercato statunitense nel 2025.
Intelligent Bio Solutions (INBS) ha completado con éxito su estudio de comparación de métodos para el sistema de detección de drogas Intelligent Fingerprinting, alcanzando una precisión del 94.1%, una sensibilidad del 82.2% y una especificidad del 100%. El estudio, realizado con CenExel y utilizando 135 donantes sanos y nueve operadores del sistema, comparó las pruebas de detección de opiáceos en sudor mediante huellas dactilares con los métodos de laboratorio LC-MS/MS. Este hito, junto con los recientes resultados positivos del estudio de farmacocinética, apoya la presentación del 510(k) ante la FDA que INBS planea realizar en el cuarto trimestre de 2024. Si se aprueba, la compañía tiene como objetivo lanzar su tecnología de detección de drogas no invasiva en el mercado estadounidense en 2025.
인텔리전트 바이오 솔루션 (INBS)은 지문 약물 선별 시스템에 대한 방법 비교 연구를 성공적으로 완료하였으며, 94.1%의 정확도, 82.2%의 민감도, 그리고 100%의 특이성을 달성했습니다. 이 연구는 135명의 건강한 기증자와 9명의 시스템 운영자를 사용하여 CenExel과 함께 진행되었으며, 지문 땀에서의 오피오이드 선별 테스트와 실험실 LC-MS/MS 방법을 비교했습니다. 이번 이정표와 최근의 긍정적인 약물 동태 연구 결과는 INBS가 2024년 4분기에 FDA 510(k) 제출을 계획하는 것을 뒷받침합니다. 승인이 이루어진다면, 회사는 2025년에 미국 시장에 비침습적인 약물 선별 기술을 출시할 계획입니다.
Intelligent Bio Solutions (INBS) a réussi à achever son étude de comparaison des méthodes pour le système de dépistage des drogues Intelligent Fingerprinting, atteignant une précision de 94,1%, une sensibilité de 82,2% et une spécificité de 100%. L'étude, réalisée avec CenExel sur 135 donneurs sains et neuf opérateurs de système, a comparé les tests de dépistage des opiacés dans la sueur des empreintes digitales avec des méthodes de laboratoire LC-MS/MS. Ce jalon, associé aux résultats positifs récents de l'étude pharmacocinétique, soutient la soumission 510(k) prévue par INBS auprès de la FDA au quatrième trimestre 2024. Si cela est approuvé, l'entreprise vise à lancer sa technologie de dépistage des drogues non invasive sur le marché américain en 2025.
Intelligent Bio Solutions (INBS) hat erfolgreich seine Methodenvergleichsstudie für das Intelligent Fingerprinting Drug Screening System abgeschlossen und dabei eine Genauigkeit von 94,1%, eine Sensitivität von 82,2% und eine Spezifität von 100% erreicht. Die Studie, die in Zusammenarbeit mit CenExel unter Verwendung von 135 gesunden Spendern und neun Systembetreibern durchgeführt wurde, verglich die Schweiß-Opiat-Screening-Tests mit Labor-LC-MS/MS-Methoden. Dieses Fortschritt, zusammen mit den jüngsten positiven Ergebnissen der Pharmakokinetik-Studie, unterstützt die geplante FDA 510(k)-Einreichung von INBS im vierten Quartal 2024. Bei Genehmigung beabsichtigt das Unternehmen, seine nicht-invasive Drogen-Screening-Technologie im US-Markt im Jahr 2025 einzuführen.
- Achieved high accuracy (94.1%) and specificity (100%) in method comparison study
- On track for FDA 510(k) submission in Q4 2024
- System demonstrated ease of use with no usage errors during study
- Potential market entry in 2025 if FDA clearance is obtained
- Relatively lower sensitivity rate (82.2%) compared to accuracy and specificity metrics
Insights
The successful completion of the method comparison study marks a significant milestone for INBS's drug screening technology. The system demonstrated
The study's comprehensive design, involving 135 donors and multiple operators, provides strong statistical validity. The perfect specificity score is particularly noteworthy, indicating zero false positives - a important factor for workplace drug testing applications. The system's ease of use and error-free operation further enhance its commercial viability. If FDA clearance is obtained, INBS could potentially disrupt the
This development positions INBS strategically in the workplace drug testing market. The non-invasive fingerprint-based approach addresses key pain points in current testing methods, offering a more dignified, efficient solution for both employers and employees. The technology's proven accuracy and ease of use could drive adoption across multiple sectors, including construction, mining, transportation and law enforcement.
For a microcap company with a market cap of just
Intelligent Fingerprinting Drug Screening System on path to FDA 510(k) submission, expected in the fourth calendar quarter of 2024
INBS will include data from recent PK study alongside results of method comparison study in 510(k) submission
NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the successful completion of its method comparison study (the “Method Study”) on its Intelligent Fingerprinting Drug Screening System (the “System”). The Method Study confirmed the sensitivity, specificity, accuracy, and usability of the System, validating its potential for use in workplace drug testing and other applications. This milestone follows INBS’ recently announced strong initial results from its Pharmacokinetic (PK) study, both of which are key achievements on the path to the Company’s FDA 510(k) submission.
The Method Study was conducted in collaboration with CenExel, a nationwide clinical research site network. It adhered to clinical research standards, including Good Clinical Practice (GCP) guidelines. The Method Study's primary objective was to compare the results of fingerprint sweat opiate screening tests with those obtained using a validated, traceable liquid chromatography-mass spectrometry (LC-MS/MS) method in a laboratory. With a diverse group of 135 healthy donors and nine system operators, the Method Study demonstrated
“The results of our Method Study reaffirm the accuracy and reliability of our fingerprint-based drug screening system,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “By establishing alignment with laboratory-confirmed results through rigorous testing, we have solidified our drug screening system’s credibility for use in safety-critical industries and beyond. This accomplishment is a significant step on our journey toward transforming drug testing with non-invasive technology.”
The Method Study evaluated the System’s three core components: the Drug Screening Cartridge, the Drug Screening Reader and the Fingerprint Collection Kit for laboratory analysis. Subjects were randomized and administered codeine doses, then provided fingerprint sweat specimens to assess the System's ability to detect and quantify drug use accurately. The Method Study’s outcomes highlight the System’s reliability, reinforcing its suitability for pre-employment and workplace drug testing applications.
If FDA 510(k) clearance were obtained, INBS believes that this would pave the way for the Company to introduce its innovative fingerprint sweat-based drug screening technology to the US market in 2025. As part of the Company's 510(k) submission, which is expected in the fourth calendar quarter of this year, INBS will include data from its recently concluded PK study alongside the results of its Method Study. The Company's clinical study achievements show the accuracy, reliability, and usability of its technology and reinforce the Company's readiness to address the growing demand for drug testing in the US across safety-critical industries such as construction, mining, and transportation, as well as in the law enforcement, drug rehabilitation, and forensic sectors.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the US include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners.
For more information, visit: http://www.ibs.inc/
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions’ public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Company Contact:
Intelligent Bio Solutions Inc.
info@ibs.inc
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Investor & Media Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
FAQ
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