Intelligent Bio Solutions Inc. (NASDAQ:INBS) on Wednesday announced the collection of new data that further reinforces the security and performance of its Intelligent Fingerprinting Drug Screening System, strengthening its FDA 510(k) submission.
"We are planning to submit our findings to the FDA in August, along with the new data collected," said Peter Passaris, Vice President of Product Development.
The company completed cybersecurity testing, including penetration testing and electromagnetic compatibility testing. It also reaffirmed the reliability and accuracy of its technology through advanced quantification techniques, including human eccrine sweat testing.
Also Read: EXCLUSIVE: Intelligent Bio's Fingerprint Drug Testing Gains Momentum With New Australian Rollout
The company used an Ultra-Micro Balance scale, one of the most sensitive instruments available, to measure the minute volumes of sweat in a single fingerprint, which is invisible to the human eye.
Because of its precision and sensitivity, this tool can measure down to 0.0000001 grams, approximately 10 million times lighter than a U.S. one-dollar bill.
"As we near the final resubmission deadline for our 510(k) process, our focus has been twofold: addressing the FDA's questions and enhancing the overall quality of our submission," said Harry Simeonidis, President and CEO at Intelligent Bio Solutions.
"With strategic input from regulatory consultants and FDA submission specialists, our R&D team has invested over 6,000 hours into testing, data aggregation, analysis, and technical reporting."
Intelligent Bio Solutions' drug testing technology uses fingerprint sweat analysis to detect common drugs of abuse.
The company supports over 450 accounts across 24 countries, with 18 distribution partners expanding its global reach.
As Intelligent Bio Solutions continues to pursue FDA clearance for its opiate test system for codeine, it continues to develop its plans to enter the multi-billion-dollar U.S. market in 2025 and scale its international operations.
Last week, Intelligent Bio announced a new global distribution agreement with SMARTOX to bring its SmarTest Patch drug detection product to international markets outside the U.S. and Canada.
The SmarTest Patch is a discreet, water-resistant, and tamper-evident device worn on the skin for 7 to 10 days at a time. It continuously collects sweat to detect various substances, including cocaine, opiates, methamphetamines, marijuana, and fentanyl.
Price Action: At the last check on Wednesday, INBS stock was down 10.2% at $2.03 during the premarket session.
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