Intelligent Bio Solutions updates FDA 510(k) timeline for drug test

NEW YORK - Intelligent Bio Solutions Inc. (NASDAQ:INBS), currently trading at $1.28 and identified as undervalued by InvestingPro analysis, announced today it will initiate clinical studies for its Intelligent Fingerprinting Drug Screening System before year-end to gather additional supporting data for FDA submission.

Following feedback from the U.S. Food and Drug Administration, the company has established a pathway to strengthen its 510(k) submission for detecting the opiate codeine. The clinical studies are scheduled to conclude in the first half of 2026, with the company anticipating FDA 510(k) clearance in the second half of 2026. According to InvestingPro data, analysts project a 7.6% revenue growth for FY2026, with 8 additional key metrics available to subscribers.

"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.

The company’s fingerprint-based drug testing technology has been adopted by over 450 accounts across 24 countries through 18 distribution partners. The system screens for recent use of drugs including opiates, cocaine, methamphetamine, and cannabis, with results available in under ten minutes. Despite reporting $3.05 million in revenue over the last twelve months, the company maintains a moderate debt level with a debt-to-equity ratio of 0.09.

Intelligent Bio Solutions continues to advance its commercial operations outside the U.S. in industries such as construction, transportation, logistics, and mining, while working toward FDA clearance to enter the U.S. market beyond the Forensic Use Only segment.

The information in this article is based on a company press release statement.

In other recent news, Intelligent Bio Solutions Inc. reported that its board of directors approved an extension of the expiration date for its Series H-1 Common Stock Purchase Warrants. The termination date has been moved to March 27, 2026, with all exercise prices and other terms remaining unchanged. Additionally, Intelligent Bio Solutions announced that the U.S. Food and Drug Administration (FDA) has requested a new 510(k) submission for its Intelligent Fingerprinting Drug Screening System, following an initial filing and subsequent feedback. The company has submitted additional information to the FDA and expects a response within six weeks. In a positive development, Intelligent Bio Solutions secured a contract with a major London public transport operator to implement its drug screening technology across 14 sites. The company has also advanced its FDA submission by collecting new data to reinforce the security and performance of its drug screening system. This data includes cybersecurity and electromagnetic compatibility testing, aimed at strengthening their 510(k) submission.

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