Intelligent Bio Solutions Announces 510(k) Submission to US FDA for Fingerprint Sweat-Based Drug Screening Technology
Intelligent Bio Solutions (INBS) has submitted a 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System, a non-invasive drug testing solution. The system demonstrated 94.1% accuracy in performance studies and showed fingerprint sweat provides reliable drug detection comparable to blood tests at 95% confidence level.
The technology delivers results within 10 minutes through sweat collected from fingertips, targeting safety-critical industries like construction, mining, and transportation, as well as law enforcement and drug rehabilitation sectors. INBS aims to enter the US market in 2025, expanding its presence beyond existing international markets where the system has already proven cost-effective and operationally efficient.
Intelligent Bio Solutions (INBS) ha presentato una notifica pre-mercato 510(k) alla FDA per il suo Sistema di Screening Droghe con Impronta Digitale, una soluzione di test antidroga non invasiva. Il sistema ha dimostrato un 94,1% di precisione negli studi di performance e ha mostrato che il sudore delle impronte digitali fornisce una rilevazione affidabile delle droghe paragonabile ai test del sangue con un livello di fiducia del 95%.
La tecnologia fornisce risultati in 10 minuti attraverso il sudore raccolto dalle punte delle dita, mirando a settori critici per la sicurezza come costruzione, estrazione mineraria e trasporti, così come nei settori delle forze dell'ordine e della riabilitazione dalle droghe. INBS punta ad entrare nel mercato statunitense nel 2025, ampliando la sua presenza oltre i mercati internazionali esistenti dove il sistema si è già dimostrato economico ed efficiente operativamente.
Intelligent Bio Solutions (INBS) ha presentado una notificación previa al mercado 510(k) a la FDA para su Sistema de Detección de Drogas con Huellas Dactilares, una solución de prueba de drogas no invasiva. El sistema demostró una exactitud del 94,1% en estudios de rendimiento y mostró que el sudor de las huellas dactilares proporciona una detección fiable de drogas comparable a las pruebas de sangre con un nivel de confianza del 95%.
La tecnología entrega resultados en 10 minutos a través del sudor recolectado de las yemas de los dedos, enfocándose en industrias críticas para la seguridad como la construcción, la minería y el transporte, así como en las fuerzas del orden y en los sectores de rehabilitación de drogas. INBS tiene como objetivo ingresar al mercado estadounidense en 2025, ampliando su presencia más allá de los mercados internacionales existentes donde el sistema ya ha demostrado ser rentable y operativo eficiente.
Intelligent Bio Solutions (INBS)는 FDA에 비침습적인 약물 테스트 솔루션인 지능형 지문 약물 스크리닝 시스템에 대한 510(k) 사전 시장 통지를 제출했습니다. 이 시스템은 성능 연구에서 94.1%의 정확도를 보여주었으며, 지문에서 수집한 땀은 95% 신뢰 수준에서 혈액 검사와 비교할 수 있는 신뢰할 수 있는 약물 탐지를 제공합니다.
이 기술은 손끝에서 수집한 땀을 통해 10분 이내에 결과를 제공하며, 건설, 광업 및 운송과 같은 안전이 중요한 산업뿐만 아니라 법 집행 및 약물 재활 분야를 대상으로 하고 있습니다. INBS는 2025년까지 미국 시장에 진출하여 이미 운영 효율성이 입증된 기존 국제 시장을 넘어 존재감을 확장하는 것을 목표로 하고 있습니다.
Intelligent Bio Solutions (INBS) a soumis une notification pré-commerciale 510(k) à la FDA pour son Système de Détection de Drogues par Empreinte Digitale, une solution de test de drogue non invasive. Le système a démontré une précision de 94,1% lors des études de performance et a montré que la sueur des empreintes digitales fournit une détection fiable des drogues comparable aux tests sanguins avec un niveau de confiance de 95%.
La technologie fournit des résultats en 10 minutes par le biais de la sueur recueillie aux bouts des doigts, ciblant des secteurs critiques pour la sécurité tels que la construction, l'exploitation minière et le transport, ainsi que les secteurs de l'application de la loi et de la réhabilitation des drogues. INBS vise à pénétrer le marché américain en 2025, en élargissant sa présence au-delà des marchés internationaux existants où le système a déjà prouvé son efficacité économique et opérationnelle.
Intelligent Bio Solutions (INBS) hat der FDA eine 510(k) Premarket-Benachrichtigung für sein intelligentes Fingerabdruck-Drogentest-System eingereicht, eine nicht-invasive Lösung für Drogentests. Das System zeigte in Leistungsstudien eine 94,1% Genauigkeit und konnte nachweisen, dass Schweiß von Fingerabdrücken eine zuverlässige Drogenidentifizierung bietet, die mit Blutuntersuchungen auf einem Vertrauensniveau von 95% vergleichbar ist.
Die Technologie liefert Ergebnisse innerhalb von 10 Minuten durch Schweiß, der von den Fingerspitzen gesammelt wird, und richtet sich an sicherheitsrelevante Branchen wie Bauwesen, Bergbau und Transport sowie an Strafverfolgungs- und Drogenrehabilitationssektoren. INBS plant, 2025 in den US-Markt einzutreten und seine Präsenz über die bestehenden internationalen Märkte hinaus auszudehnen, wo das System bereits kosteneffektiv und betrieblich effizient nachgewiesen wurde.
- 94.1% accuracy demonstrated in performance studies
- Results delivered in 10 minutes
- Successful validation through Pharmacokinetic (PK) study
- Planned entry into one of the largest drug screening markets (US) in 2025
- System already adopted and proven successful in international markets
- FDA approval still pending
- Market entry delayed until 2025
- Faces competition from established drug testing methods
Insights
The FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System represents a significant development with robust clinical validation. The 94.1% accuracy rate and pharmacokinetic study results demonstrating correlation with blood samples at 95% confidence level are particularly impressive technical metrics. The 10-minute result time and non-invasive nature address key pain points in current drug screening methods. The technology's ability to detect drugs through fingerprint sweat could revolutionize workplace testing, especially in safety-critical sectors.
The system's unique approach could capture significant market share in the US drug screening market, which is valued at several billion dollars annually. The validation data suggests the technology is well-positioned to meet regulatory requirements, though FDA review timelines typically range from 3-6 months for 510(k) submissions.
For a micro-cap company with a
NEW YORK, Dec. 18, 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 submission of its 510(k) premarket notification to the US Food and Drug Administration (FDA) for clearance following FDA review of its Intelligent Fingerprinting Drug Screening System (the "System"), an innovative, rapid and pain-free method for drug screening. The submission represents a critical milestone on the Company’s path to realizing its goal of entering the US market with its drug testing solution in 2025.
The Company's 510(k) submission included performance data and validation studies, including a method comparison study that demonstrated the System’s
With existing adoption in international markets, the System has already demonstrated its value in delivering substantial cost savings, operational efficiencies, and rapid results with minimal disruption. Entry into the US, one of the largest drug screening markets globally, will support INBS' ongoing global expansion, presenting opportunities for revenue growth, market share acquisition, and strategic partnerships.
The System’s accuracy and non-invasive nature position it to become a disruptive technology in safety-critical industries such as construction, mining, and transportation. Additionally, its application in the law enforcement, drug rehabilitation, and forensic sectors offers diverse revenue streams. Expansion into the US would strengthen the Company's financial performance and enhance its position as a leader in pain-free testing solutions.
"The submission of our 510(k) application to the FDA is an impactful moment for all of us at Intelligent Bio Solutions, who have worked with perseverance and an intense focus to deliver our 510(k) package on time," said Harry Simeonidis, President and CEO at INBS. "Our team showed agility and resourcefulness, working with our clinical research partners to execute our clinical study plan and analyze the data. We are excited about our planned entry into the US market, the opportunities for growth, and the transformational impact that we believe we will have in the drug screening market with our innovative technology."
The Intelligent Fingerprinting Drug Screening System is designed to detect drugs of abuse through sweat collected from the fingertips and provide results within ten minutes. This non-invasive, hygienic, and easy-to-administer test is particularly beneficial in safety-critical industries such as construction, transportation, mining, and logistics. The System has broader applicability across the law enforcement, drug rehabilitation, and forensic sectors, highlighting its vast market potential.
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
LinkedIn | Twitter
Investor & Media Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5889a951-88d1-40b1-a69b-60ab1c714c5d
FAQ
What accuracy rate did INBS's Fingerprint Drug Screening System achieve in clinical trials?
When does INBS plan to enter the US drug screening market?
How long does it take to get results from INBS's drug screening system?
What industries are targeted for INBS's fingerprint drug screening technology?
How does INBS's drug screening system collect samples?
