Intelligent Bio Solutions Strengthens FDA 510(k) Package with New Cybersecurity and Performance Data Ahead of Planned U.S. Market Launch
Intelligent Bio Solutions (Nasdaq: INBS) has submitted additional information to the FDA as part of its 510(k) clearance process for its fingerprint sweat-based drug screening technology. The submission includes extensive new cybersecurity and performance data, comprising 23 test reports and over 100 supporting attachments totaling more than 1900 pages.
The company invested 10,000 hours in data collection and conducted intensive cybersecurity testing, including penetration and electromagnetic compatibility testing. The technology's accuracy was reaffirmed using advanced quantification methods, including human eccrine sweat testing with an Ultra-Micro Balance scale.
Currently used across 450 accounts in 24 countries, INBS expects an FDA response within six weeks and aims to enter the multi-billion-dollar U.S. market in 2025, focusing initially on its opiate test system for codeine.
Intelligent Bio Solutions (Nasdaq: INBS) ha inviato ulteriori informazioni alla FDA nell'ambito del processo di approvazione 510(k) per la sua tecnologia di screening dei farmaci basata sul sudore delle impronte digitali. La documentazione comprende nuovi dati approfonditi su sicurezza informatica e prestazioni, con 23 rapporti di prova e oltre 100 allegati di supporto per un totale di più di 1900 pagine.
L'azienda ha dedicato 10.000 ore alla raccolta dati e ha effettuato test intensivi di sicurezza informatica, inclusi test di penetrazione e compatibilità elettromagnetica. L'accuratezza della tecnologia è stata confermata utilizzando metodi avanzati di quantificazione, tra cui test sul sudore eccrino umano con una bilancia Ultra-Micro Balance.
Attualmente utilizzata in 450 account in 24 paesi, INBS prevede una risposta dalla FDA entro sei settimane e punta a entrare nel mercato statunitense da miliardi di dollari nel 2025, concentrandosi inizialmente sul sistema di test per oppiacei relativo alla codeina.
Intelligent Bio Solutions (Nasdaq: INBS) ha presentado información adicional a la FDA como parte del proceso de autorización 510(k) para su tecnología de detección de drogas basada en el sudor de las huellas dactilares. La presentación incluye nuevos datos extensos sobre ciberseguridad y rendimiento, que comprenden 23 informes de prueba y más de 100 anexos de apoyo con un total de más de 1900 páginas.
La compañía invirtió 10,000 horas en la recopilación de datos y realizó pruebas intensivas de ciberseguridad, incluyendo pruebas de penetración y compatibilidad electromagnética. La precisión de la tecnología fue reafirmada utilizando métodos avanzados de cuantificación, incluyendo pruebas de sudor ecrino humano con una balanza Ultra-Micro Balance.
Actualmente utilizada en 450 cuentas en 24 países, INBS espera una respuesta de la FDA dentro de seis semanas y apunta a ingresar al mercado estadounidense multimillonario en 2025, enfocándose inicialmente en su sistema de prueba para opiáceos para codeína.
Intelligent Bio Solutions (나스닥: INBS)는 지문 땀 기반 약물 검사 기술에 대한 510(k) 승인 절차의 일환으로 FDA에 추가 정보를 제출했습니다. 제출 자료에는 23개의 시험 보고서와 100개 이상의 지원 첨부 문서가 포함되어 있으며, 총 1900페이지 이상에 달하는 광범위한 사이버보안 및 성능 데이터가 포함되어 있습니다.
회사는 데이터 수집에 10,000시간을 투자했으며 침투 테스트 및 전자기 적합성 테스트를 포함한 집중적인 사이버보안 테스트를 수행했습니다. 이 기술의 정확성은 Ultra-Micro Balance 저울을 사용한 인간 땀샘 땀 테스트 등 고급 정량화 방법으로 재확인되었습니다.
현재 24개국 450개 계정에서 사용 중인 INBS는 FDA의 응답을 6주 내에 받을 것으로 예상하며, 2025년 미국의 수십억 달러 규모 시장 진입을 목표로 처음에는 코데인에 대한 아편계 테스트 시스템에 집중할 계획입니다.
Intelligent Bio Solutions (Nasdaq : INBS) a soumis des informations supplémentaires à la FDA dans le cadre de son processus d'autorisation 510(k) pour sa technologie de dépistage des drogues basée sur la sueur des empreintes digitales. La soumission comprend de nombreuses nouvelles données sur la cybersécurité et les performances, incluant 23 rapports de tests et plus de 100 pièces jointes totalisant plus de 1900 pages.
L'entreprise a investi 10 000 heures dans la collecte de données et a réalisé des tests intensifs de cybersécurité, notamment des tests de pénétration et de compatibilité électromagnétique. La précision de la technologie a été confirmée grâce à des méthodes avancées de quantification, incluant des tests sur la sueur eccrine humaine avec une balance Ultra-Micro Balance.
Utilisée actuellement dans 450 comptes dans 24 pays, INBS attend une réponse de la FDA dans un délai de six semaines et vise à pénétrer le marché américain de plusieurs milliards de dollars en 2025, en se concentrant initialement sur son système de test des opiacés pour la codéine.
Intelligent Bio Solutions (Nasdaq: INBS) hat der FDA im Rahmen des 510(k)-Zulassungsverfahrens für seine schweißbasierte Drogen-Screening-Technologie mittels Fingerabdruck zusätzliche Informationen übermittelt. Die Einreichung umfasst umfangreiche neue Daten zur Cybersicherheit und Leistungsfähigkeit, darunter 23 Testberichte und über 100 unterstützende Anhänge mit insgesamt mehr als 1900 Seiten.
Das Unternehmen investierte 10.000 Stunden in die Datenerhebung und führte intensive Cybersicherheitstests durch, einschließlich Penetrations- und elektromagnetischer Verträglichkeitstests. Die Genauigkeit der Technologie wurde mit fortschrittlichen Quantifizierungsmethoden bestätigt, darunter Tests mit menschlichem ekkrinem Schweiß unter Verwendung einer Ultra-Micro-Balance-Waage.
Derzeit wird die Technologie in 450 Konten in 24 Ländern eingesetzt. INBS erwartet eine FDA-Antwort innerhalb von sechs Wochen und plant, 2025 in den milliardenschweren US-Markt einzutreten, wobei der Fokus zunächst auf dem Opioid-Testsystem für Codein liegt.
- Extensive validation with 10,000 hours of data collection and 23 detailed test reports
- Strong international presence with 450 accounts across 24 countries and 18 global distribution partners
- Advanced testing confirms technology accuracy using Ultra-Micro Balance scale
- Potential entry into multi-billion-dollar U.S. market pending FDA approval
- FDA clearance still pending with 6-week review period ahead
- Limited initial U.S. market entry focusing only on opiate test system for codeine
Insights
INBS strengthens FDA submission with new data, boosting chances for 510(k) clearance of their fingerprint drug screening technology.
Intelligent Bio Solutions has made significant progress in their FDA 510(k) clearance journey by submitting comprehensive additional information that substantially strengthens their application. The company has invested in generating robust cybersecurity data, including penetration and electromagnetic compatibility testing that demonstrates their fingerprint sweat-based drug screening technology's resilience across various environments. What's particularly impressive is the extraordinary volume of new evidence - 10,000 hours dedicated to data collection, resulting in 23 detailed test reports and over 100 supporting attachments totaling more than 1900 pages.
The reaffirmation of the technology's accuracy using advanced quantification methods, specifically human eccrine sweat testing with an Ultra-Micro Balance scale, is technically significant. This ultra-sensitive measuring approach confirms the system can reliably detect and analyze the minute sweat volumes present in a single fingerprint - a critical validation point for the technology's core functionality and precision.
From a regulatory perspective, the FDA's expected response timeline of six weeks suggests the submission is comprehensive enough to facilitate a relatively prompt review. The company appears well-positioned for their planned 2025 U.S. market entry, targeting clearance specifically for their opiate test system for codeine. Their existing international presence across 450 accounts in 24 countries provides a solid foundation of real-world evidence that will likely strengthen their regulatory case with the FDA. The multi-billion-dollar U.S. market represents a significant commercial opportunity that could substantially accelerate the company's growth trajectory if clearance is obtained.
FDA response expected within six weeks; Company remains focused on 2025 U.S. expansion
NEW YORK, Aug. 06, 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 announced the submission of its Additional Information ("AI") response to the United States Food and Drug Administration ("FDA") as part of its ongoing 510(k) clearance process for planned entry to the U.S. market later this year. The response includes new positive data that strengthens the Company’s 510(k) submission and further validates the security and performance of its innovative fingerprint sweat-based drug screening technology.
The Company’s updated submission incorporates data from intensive cybersecurity testing, including penetration and electromagnetic compatibility testing. These efforts have reinforced the system’s resilience across varied environments and supported targeted updates to further strengthen platform integrity and dependability. An extraordinary 10,000 hours were dedicated to the collection of new data for the submission, which included 23 detailed test reports and more than 100 supporting attachments, totaling over 1900 pages, along with over 7800 lines of data collected throughout the process.
"We are both pleased and proud to submit our recent findings to the FDA," said Peter Passaris, Vice President of Product Development at Intelligent Bio Solutions. “The quality, depth, and regulatory alignment of our current submission represents a significant advancement. Our team has shown aptitude and diligence at the highest level throughout the information request period, and we are confident in the updated package we’re submitting."
INBS has also reaffirmed the accuracy of its technology using advanced quantification methods, including human eccrine sweat testing. An Ultra-Micro Balance scale, an extremely sensitive measuring device, confirmed the system’s capability to detect and analyze minute sweat volumes found in a single fingerprint.
“Securing FDA clearance has been a top priority as we look to bring our fingerprint sweat-based solution to more markets, particularly those with significant commercial potential, such as the multi-billion-dollar U.S. market,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “The data we have gathered reflects the outstanding work of our R&D team, whose technical expertise has strengthened the case for our technology’s accuracy and reliability.”
INBS continues to advance its U.S. expansion strategy, prioritizing FDA clearance for its opiate test system for codeine and U.S. market entry in 2025. The Company’s non-invasive drug screening technology is used across more than 450 accounts in 24 countries, supporting workplace, law enforcement and justice sectors. With 18 global distribution partners and growing awareness and adoption, INBS is steadily expanding its international presence. Entry into the multi-billion-dollar U.S. market will open significant opportunities for the Company as it pursues its global expansion plans. The Company expects a response from the FDA within six weeks.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, 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, mining, drug treatment organizations, and coroners.
For more information, visit https://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.
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