Intelligent Bio Solutions Advances Preparations and Provides Updated Timeline for Anticipated FDA 510(k) Submission and Clearance
Intelligent Bio Solutions (Nasdaq: INBS) has provided an updated timeline for FDA 510(k) clearance of its Intelligent Fingerprinting Drug Screening System for opiate codeine detection. Following FDA feedback, the company will conduct additional clinical studies starting before year-end 2025, with completion expected in H1 2026. FDA clearance is anticipated in H2 2026.
The company's drug testing technology has already gained significant traction globally, with 450 accounts across 24 countries and 18 distribution partners. INBS continues to expand its presence in various industries including construction, transportation, logistics, and mining, while working to move beyond the Forensic Use Only market in the US.
Intelligent Bio Solutions (Nasdaq: INBS) ha fornito una nuova timeline per l'approvazione 510(k) FDA del suo sistema di fingerprinting intelligente per lo screening delle droghe con rilevamento di oppiacei e codeina. Dopo il feedback della FDA, l'azienda porterà avanti studi clinici aggiuntivi entro la fine del 2025, con completamento previsto nel 1º semestre del 2026. L'approvazione FDA è prevista nel 2º semestre del 2026.
La tecnologia di testing delle droghe dell'azienda ha già ottenuto notevole trazione a livello globale, con 450 account in 24 paesi e 18 partner di distribuzione. INBS continua ad espandere la propria presenza in settori quali costruzione, trasporti, logistica e mining, lavorando nel contempo per superare il mercato Forensic Use Only negli Stati Uniti.
Intelligent Bio Solutions (Nasdaq: INBS) ha proporcionado una nueva cronología para la aprobación 510(k) de la FDA de su sistema de detección de consumo de opiáceos mediante huellas dactilares inteligentes. Tras los comentarios de la FDA, la compañía realizará estudios clínicos adicionales antes de fin de 2025, con finalización prevista en el primer semestre de 2026. Se espera la aprobación de la FDA en el segundo semestre de 2026.
La tecnología de pruebas de drogas de la empresa ya ha ganado tracción global, con 450 cuentas en 24 países y 18 socios de distribución. INBS continúa expandiendo su presencia en industrias como construcción, transporte, logística y minería, mientras trabaja para avanzar más allá del mercado de uso forense exclusivo en EE. UU.
Intelligent Bio Solutions (Nasdaq: INBS)가 opiate 코데인 탐지를 위한 지능형 지문 기반 약물 스크리닝 시스템의 FDA 510(k) 승인에 대한 업데이트된 일정표를 제공했습니다. FDA의 피드백에 따라 회사는 2025년 말 이전에 추가 임상 연구를 수행할 예정이며, 2026년 상반기에 완료를 기대합니다. FDA 승인은 2026년 하반기에 예상됩니다.
해당 기술은 이미 전 세계적으로 큰 관심을 받고 있으며, 24개국의 450개 계정과 18개의 유통 파트너를 보유하고 있습니다. INBS는 건설, 운송, 물류, 광업 등 다양한 산업에서 존재감을 확장하고 있으며, 미국 내에서 Forensic Use Only 시장을 넘어서는 노력을 계속하고 있습니다.
Intelligent Bio Solutions (Nasdaq: INBS) a fourni un calendrier actualisé pour l'autorisation FDA 510(k) de son système de dépistage des drogues par empreintes intelligentes, destiné à la détection d’opiacés et de codéine. Suite aux retours de la FDA, la société mènera des études cliniques supplémentaires avant la fin de 2025, avec une finalisation prévue au 1er semestre 2026. L’autorisation FDA est attendue au 2e semestre 2026.
La technologie de dépistage de drogues de la société a déjà connu une forte traction à l’échelle mondiale, avec 450 comptes dans 24 pays et 18 partenaires de distribution. INBS continue d’étendre sa présence dans des secteurs tels que la construction, les transports, la logistique et l’exploitation minière, tout en travaillant à sortir du marché Forensic Use Only aux États-Unis.
Intelligent Bio Solutions (Nasdaq: INBS) hat einen aktualisierten Zeitplan für die FDA 510(k)-Freigabe seines Intelligent Fingerprinting Drug Screening Systems zur Erkennung von Opioiden und Codein vorgelegt. Nach dem Feedback der FDA wird das Unternehmen zusätzliche klinische Studien noch vor Ende 2025 durchführen, deren Abschluss im 1. Halbjahr 2026 erwartet wird. Die FDA-Zulassung wird voraussichtlich im 2. Halbjahr 2026 erfolgen.
Die Drogentesttechnologie des Unternehmens hat weltweit bereits erhebliches Momentum, mit 450 Konten in 24 Ländern und 18 Vertriebspartnern. INBS erweitert seine Präsenz in verschiedenen Branchen wie Bauwesen, Transport, Logistik und Bergbau und arbeitet daran, den Markt Forensic Use Only in den USA zu verlassen.
Intelligent Bio Solutions (Nasdaq: INBS) قدمت جدولاً زمنيًا محدثًا لتخليص FDA 510(k) لنظامها الذكي لكشف المواد المخدرة باستخدام بصمة الأصابع لكشف الأفيون والكوْدين. وفقًا لتعليقات FDA، ستجري الشركة دراسات سريرية إضافية قبل نهاية عام 2025، مع توقع الإكمال في النصف الأول من 2026. من المتوقع أن تصدر FDA الموافقة في النصف الثاني من 2026.
تكنولوجيا اختبار المخدرات للشركة قد حازت بالفعل مكانة قوية على مستوى العالم، مع 450 عميلًا في 24 دولة و 18 شريك توزيع. تستمر INBS في توسيع حضورها في صناعات مختلفة بما في ذلك البناء، النقل، اللوجستيات، والتعدين، مع العمل للسير خارج سوق للاستخدام الجنائي فقط في الولايات المتحدة.
Intelligent Bio Solutions (Nasdaq: INBS) 已提供其智能指纹药物筛查系统在阿片类药物和可待因检测方面的 FDA 510(k) 审批更新时间线。在收到 FDA 反馈后，公司将于 2025 年底前启动额外的临床研究，预计在2026 年上半年完成。FDA 审批预计在2026 年下半年。
该公司的药物检测技术已在全球获得显著增势，拥有24 个国家的 450 个账户和18 个分销伙伴。INBS 继续扩大在建筑、交通、物流和矿业等行业的存在，并努力在美国超越仅限法医使用市场。
- Strong global presence with 450 accounts across 24 countries
- Established distribution network with 18 partners
- Clear regulatory pathway established for FDA 510(k) submission
- Diverse industry adoption including construction, transportation, and mining sectors
- Extended timeline for FDA clearance pushing to H2 2026
- Additional clinical studies required before FDA submission
- Limited to Forensic Use Only market in the US until FDA clearance
Insights
INBS delays FDA submission timeline for its fingerprinting drug test to 2026, with additional clinical studies required following FDA feedback.
Intelligent Bio Solutions has adjusted its regulatory timeline for its Intelligent Fingerprinting Drug Screening System after receiving FDA feedback. The company will now conduct additional clinical studies starting before year-end 2025 to strengthen its 510(k) submission package, with studies expected to conclude in H1 2026. This pushes the anticipated FDA clearance to the second half of 2026.
This regulatory update reveals that INBS's previous submission strategy wasn't sufficient to secure FDA clearance for its fingerprint-based drug testing technology. The need for supplemental clinical validation suggests the FDA identified data gaps that must be addressed before the company can bring its technology to the U.S. market beyond its current "Forensic Use Only" designation.
Despite this regulatory delay, the company highlights that its technology has gained commercial traction outside the U.S., with adoption by over 450 accounts across 24 countries through 18 distribution partners. The device's non-invasive testing approach for detecting codeine could provide advantages over conventional drug testing methods, but U.S. market entry for clinical applications remains contingent on successful 510(k) clearance.
This timeline shift indicates a significant delay in the company's U.S. commercialization strategy, as FDA clearance is now at least 9-12 months away. The company's decision to pursue additional clinical validation suggests a strategic pivot to ensure regulatory success, though it extends the pathway to accessing the lucrative U.S. healthcare market.
The Company is initiating clinical studies to further validate Intelligent Fingerprinting Drug Screening System
INBS anticipates FDA 510(k) clearance in the second half of 2026
NEW YORK, Sept. 26, 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 is providing an update on the timeline for anticipated FDA 510(k) clearance for the use of its Intelligent Fingerprinting Drug Screening System for the opiate codeine.
Following recent feedback from the U.S. Food and Drug Administration (FDA), INBS has established a pathway to gather additional supporting data to strengthen its new 510(k) submission to the FDA. The Company plans to commence clinical studies to further validate its Intelligent Fingerprinting Drug Screening System before calendar year-end. These studies are scheduled to conclude in the first half of the 2026 calendar year. INBS anticipates FDA 510(k) clearance in the second half of the 2026 calendar year.
“We have a clear and achievable timeline for resubmitting our 510(k) application. The additional clinical data we are generating will supplement existing data and strengthen our package,” said Peter Passaris, Vice President of Product Development at Intelligent Bio Solutions. “We are committed to bringing our innovative technology to the U.S. market, while continuing to focus on the growth of the overall business.”
INBS’s drug testing technology has been adopted by over 450 accounts in 24 countries, with 18 distribution partners expanding its global reach. The Company continues to advance its commercial operations outside the U.S., with growing adoption across industries, including construction, transportation, logistics, and mining, while simultaneously working toward FDA clearance for U.S. entry beyond the Forensic Use Only market.
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 U.S. 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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