NanoDx, Inc., a developer of breakthrough point-of-care diagnostic solutions and SkyWater Technology, the trusted technology realization partner, announced the first commercially ready nano biosensor to yield a protein response. The unique size and electrical properties of nanosensors allow detection of biomarkers and infections never before possible in a simple, portable, point-of-care system. This milestone enables NanoDx to prepare and submit the product for FDA review and eventual commercialization.
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Nanosensor technology utilizes the distinctive properties of nanomaterials to detect, measure, and analyze physical quantities at the nanoscale level. Compared to traditional detection methods, nanosensors enable real-time monitoring and demonstrate significant advantages in cost. NanoDx’s system utilizes a patented nanosensor design that includes an array of highly sensitive nanowires that measure electrical resistance and are functionalized with antibodies that bind with target biomarkers.
In July 2021, NanoDx entered into a licensing agreement with IBM Research for the use of its complementary metal-oxide semiconductor (CMOS) compatible nanosensors technology, giving NanoDx the potential to provide an objective and real-time assessment of injury or infection at a greater sensitivity and specificity than traditional and other point-of-care tests. Building upon the licensed IBM Research technology, NanoDx partnered with SkyWater to co-develop and produce the nanoscale sensors. Subsequently, NanoDx engaged with FTI Consulting to further transition the organization from product development to preparation for commercialization.
“Leveraging the licensed IBM Research technology in collaboration with SkyWater and FTI Consulting has enabled us to achieve this milestone in record time. We can now take advantage of our FDA breakthrough designation for traumatic brain injury and prepare for pivotal trials followed by FDA submission,” said NanoDx President and CEO, George Serafin. “SkyWater’s support has been instrumental in enabling us to quickly develop our diagnostic solution and to advance its production readiness. We plan to follow this with other disease applications to address critical unmet market needs.”
“NanoDx, using IBM-licensed CMOS technology, has been co-developing this breakthrough at SkyWater by leveraging our Technology as a Service model to rapidly demonstrate concepts and optimize their architecture as they prepare to go to market and ramp to production,” said Dr. Steven Kosier, SkyWater CTO. “We are pleased with the accelerated timeline we were able to achieve and are proud to enable breakthrough advantages for diagnostic healthcare solutions.”