Zinger Key Points
- Intelligent Bio test system showed 94.1% accuracy in studies, aligning fingerprint sweat data closely with blood for drug detection.
- The FDA has requested additional information for INBS's 510(k) submission.
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On Tuesday, Intelligent Bio Solutions Inc. INBS provided 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.
In December 2024, the company submitted 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.
The FDA has reviewed and issued an Additional Information request. If additional data is required, the FDA clearance process may take three to six months or longer.
The company's 510(k) submission included performance data and validation studies, including a method comparison study that demonstrated the system's 94.1% accuracy and a PK study that showed fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative PK data closely aligned to blood, based on statistical comparisons made at the 95% confidence level.
As Intelligent Bio Solutions 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.
"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," said Harry Simeonidis, President and CEO at INBS.
Last week, Intelligent Bio Solutions announced that it expects to receive its sixth patent in the United States, which will strengthen the protection of the lateral flow technology core to its Intelligent Fingerprinting Drug Testing Solution.
Price Action: At the last check on Tuesday, INBS stock was up 4.74% at $2.21 during the premarket session.
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