Intelligent Bio Solutions’ FDA Clearance Process Remains on Track for 2025 U.S. Launch
Intelligent Bio Solutions (NASDAQ: INBS) provided an update on its FDA clearance process for the Intelligent Fingerprint Drug Screening System, confirming its planned 2025 U.S. launch remains on track. The company submitted its 510(k) premarket notification on December 18, 2024, for its opiate test system, classified as a Class II device.
The submission included performance data showing 94.1% accuracy and Pharmacokinetic (PK) study results demonstrating fingerprint sweat's reliability for drug detection. The FDA has issued an Additional Information (AI) request, temporarily pausing the 90-day review period. While FDA clearance typically takes 3-6 months, the process may extend if additional data is required.
The system is currently operational in 19 countries with over 400 accounts globally. INBS plans to pursue FDA clearance for additional drug classes on its panel while preparing for entry into the U.S. market.
Intelligent Bio Solutions (NASDAQ: INBS) ha fornito un aggiornamento sul processo di autorizzazione della FDA per il Sistema di Screening dei Farmaci con Impronte Digitali Intelligenti, confermando che il lancio previsto negli Stati Uniti nel 2025 è ancora in programma. L'azienda ha presentato la sua notifica pre-commerciale 510(k) il 18 dicembre 2024 per il suo sistema di test sugli oppiacei, classificato come dispositivo di Classe II.
La presentazione ha incluso dati sulle prestazioni che mostrano un'accuratezza del 94,1% e risultati di studi di farmacocinetica (PK) che dimostrano l'affidabilità del sudore delle impronte digitali per la rilevazione di droghe. La FDA ha emesso una richiesta di Informazioni Aggiuntive (AI), sospendendo temporaneamente il periodo di revisione di 90 giorni. Sebbene l'autorizzazione della FDA richieda tipicamente da 3 a 6 mesi, il processo potrebbe estendersi se sono necessarie ulteriori informazioni.
Il sistema è attualmente operativo in 19 paesi con oltre 400 account a livello globale. INBS prevede di richiedere l'autorizzazione della FDA per ulteriori classi di farmaci nel suo pannello, mentre si prepara per l'ingresso nel mercato statunitense.
Intelligent Bio Solutions (NASDAQ: INBS) proporcionó una actualización sobre su proceso de autorización por parte de la FDA para el Sistema de Detección de Drogas con Huellas Digitales Inteligentes, confirmando que su lanzamiento previsto en EE. UU. para 2025 sigue en marcha. La empresa presentó su notificación previa al mercado 510(k) el 18 de diciembre de 2024 para su sistema de prueba de opiáceos, clasificado como dispositivo de Clase II.
La presentación incluyó datos de rendimiento que muestran una precisión del 94.1% y resultados de estudios de farmacocinética (PK) que demuestran la fiabilidad del sudor de las huellas digitales para la detección de drogas. La FDA ha emitido una solicitud de Información Adicional (AI), pausando temporalmente el período de revisión de 90 días. Aunque la autorización de la FDA generalmente toma de 3 a 6 meses, el proceso puede extenderse si se requieren datos adicionales.
El sistema está actualmente operativo en 19 países con más de 400 cuentas a nivel global. INBS planea buscar la autorización de la FDA para clases adicionales de drogas en su panel mientras se prepara para ingresar al mercado estadounidense.
인텔리전트 바이오 솔루션즈 (NASDAQ: INBS)는 지문 약물 검사 시스템의 FDA 승인 프로세스에 대한 업데이트를 제공하며, 2025년 미국 출시 계획이 순조롭게 진행되고 있음을 확인했습니다. 이 회사는 2024년 12월 18일에 오피오이드 테스트 시스템에 대한 510(k) 사전 시장 통지를 제출했으며, 이는 클래스 II 장치로 분류됩니다.
제출에는 94.1%의 정확도를 보여주는 성능 데이터와 약리학적 연구(PK) 결과가 포함되어 있으며, 이는 지문 땀의 약물 탐지 신뢰성을 입증합니다. FDA는 추가 정보(AI) 요청을 발행하여 90일 검토 기간을 일시 중지했습니다. FDA 승인은 일반적으로 3-6개월이 걸리지만, 추가 데이터가 필요할 경우 과정이 연장될 수 있습니다.
현재 이 시스템은 19개국에서 운영 중이며, 전 세계적으로 400개 이상의 계정이 있습니다. INBS는 미국 시장 진입을 준비하면서 패널의 추가 약물 클래스에 대한 FDA 승인을 추구할 계획입니다.
Intelligent Bio Solutions (NASDAQ: INBS) a fourni une mise à jour sur son processus d'autorisation par la FDA pour le Système de Dépistage des Drogues par Empreintes Digitales Intelligentes, confirmant que son lancement prévu aux États-Unis en 2025 reste sur la bonne voie. L'entreprise a soumis sa notification préalable au marché 510(k) le 18 décembre 2024 pour son système de test d'opiacés, classé comme dispositif de Classe II.
La soumission a inclus des données de performance montrant une précision de 94,1% et des résultats d'études pharmacocinétiques (PK) démontrant la fiabilité de la sueur des empreintes digitales pour la détection de drogues. La FDA a émis une demande d'Informations Supplémentaires (AI), suspendant temporairement la période de révision de 90 jours. Bien que l'autorisation de la FDA prenne généralement de 3 à 6 mois, le processus peut s'étendre si des données supplémentaires sont nécessaires.
Le système est actuellement opérationnel dans 19 pays avec plus de 400 comptes à l'échelle mondiale. INBS prévoit de demander l'autorisation de la FDA pour d'autres classes de drogues sur son panneau tout en se préparant à entrer sur le marché américain.
Intelligent Bio Solutions (NASDAQ: INBS) hat ein Update zu seinem FDA-Zulassungsprozess für das Intelligente Fingerabdruck-Drogenscreening-System bereitgestellt und bestätigt, dass der geplante US-Launch im Jahr 2025 auf Kurs bleibt. Das Unternehmen hat am 18. Dezember 2024 seine 510(k) Vorabbenachrichtigung für sein Opiat-Testsystem eingereicht, das als Klasse II-Gerät eingestuft ist.
Die Einreichung enthielt Leistungsdaten, die eine Genauigkeit von 94,1% zeigen, sowie Ergebnisse von pharmakokinetischen (PK) Studien, die die Zuverlässigkeit des Schweißes aus Fingerabdrücken zur Drogenüberprüfung belegen. Die FDA hat eine Anfrage nach zusätzlichen Informationen (AI) gestellt, wodurch der 90-tägige Prüfzeitraum vorübergehend ausgesetzt wurde. Während die FDA-Zulassung normalerweise 3-6 Monate dauert, kann sich der Prozess verlängern, wenn zusätzliche Daten erforderlich sind.
Das System ist derzeit in 19 Ländern mit über 400 Konten weltweit im Einsatz. INBS plant, die FDA-Zulassung für zusätzliche Drogenklassen in seinem Panel zu verfolgen, während es sich auf den Eintritt in den US-Markt vorbereitet.
- 94.1% accuracy demonstrated in method comparison study
- Strong global presence with 400+ accounts across 19 countries
- FDA clearance process progressing as expected
- PK study showed reliable correlation with blood test results
- FDA review timeline extended due to Additional Information request
- Current submission to opiate test system only, requiring additional submissions for other drug classes
Insights
Intelligent Bio Solutions' FDA clearance update provides a neutral development in their regulatory pathway. The company has submitted its 510(k) application for the Intelligent Fingerprint Drug Screening System and has received an Additional Information (AI) request from the FDA - a standard part of the review process that temporarily pauses the 90-day review clock.
The company's fingerprint-based opiate test system has demonstrated
The timeline characterization of "on track for 2025 launch" appears realistic given the current regulatory stage. FDA clearance processes typically take 3-6 months when AI requests are involved, aligning with the company's projection. The fact that the product is already commercialized in 19 countries provides some validation of its market readiness, though U.S. regulatory standards have different requirements.
This update represents a procedural milestone rather than a definitive regulatory achievement. The company must still satisfy the FDA's additional information request before the review clock restarts, and successful clearance remains contingent on the agency's final determination.
NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today provided shareholders with a status update on the FDA clearance process for its Intelligent Fingerprint Drug Screening System, which remains on track for launch in the U.S. in 2025 targeting its opiate test system for codeine, as validated in the Company’s Pharmacokinetic (PK) study.
On December 18, 2024, the Company announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System, which the FDA classified as a 21 CFR 862.3650, Opiate Test System, a Class II device requiring submission of a 510(k) premarket notification. This submission marked a critical milestone in the Company’s efforts to enter the U.S. market with its drug testing system in 2025.
The Company's 510(k) submission included performance data and validation studies, including a method comparison study that demonstrated the system’s
INBS’s 510(k) submission started the 90-day period within which the FDA is required to review and respond to 510(k) submissions. As expected, the FDA has reviewed and responded with questions by issuing an Additional Information (AI) request. When the FDA issues an AI request, the 90-day review clock is paused. The Company has reviewed the AI request and is in the process of responding so that the FDA can restart the review clock. As a result of this process, although the FDA is required to review and respond in 90 days, it is not uncommon for the FDA clearance process to take three to six months or longer if additional data is required. As INBS awaits FDA clearance, it continues to develop its plans to enter the multi-billion-dollar U.S. market in 2025 and pursue FDA clearance for additional drug classes on its panel. The Company’s full panel test is already widely adopted, with a presence in 19 countries and over 400 accounts globally.
"The submission of our 510(k) premarket notification to the FDA marked a pivotal step in the journey to bring our Intelligent Fingerprint Drug Screening System to the U.S. market," said Harry Simeonidis, President and CEO at INBS. "We appreciate the thoroughness of the FDA’s process, which aligns with our expectations. As we await FDA clearance, we remain confident in the strength of our data, which demonstrates the accuracy, reliability, and usability of our technology. We are actively preparing for our planned U.S. launch in 2025, where we see significant opportunities to revolutionize drug screening with our non-invasive, rapid testing solution."
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 U.S. 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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