IVDs use fluorescent light from reporter molecules (tagged antibodies) to indicate the existence of an antigen in a patient’s sample, such as pathogens (virus, bacteria, fungus, protein), gene mutations, or a tumor biomarker. In early stages, the amount of fluorescent light produced by the reporter molecule may be insufficient to yield a definitive positive test, yielding instead a so-called false negative.
In initial testing, NANOPEC's MetaFluorex enhanced fluorescent signals by factors as large as 100 times, depending on the assay, when compared to the glass slides currently used for in-vitro diagnostics. This enhancement decreases the probability that a patient will receive the wrong diagnosis because the fluorescence signal is too weak or the biomarker concentration too low to be detected. The ceramic films are made without cytotoxic materials and safe to use in the presence of living cells.
There are several challenges relating to incumbent IVD technologies, which NANOPEC is addressing with its offering. A false positive reading, for example, telling a healthy patient they are sick, has an emotional impact but it is not life-threatening. Re-testing is a simple corrective action that can prevent some individuals undergoing unnecessary costly or harmful treatments. Conversely, a false negative reading, telling a sick patient they are healthy, can have serious, and potentially fatal, consequences. Cancer and debilitating chronic conditions can greatly benefit from early diagnosis and intervention. Incumbent IVD tests also use costly reagents, such as primary and secondary antibodies. Instruments with high sensitivity are often needed to compensate for low signals. Because of the enhanced fluorescence signals produced by MetaFluorex ceramic films, a significant reduction in the use of these costly consumables could be achieved.
“We believe that there is an unmet need in the healthcare industry for cost-effective materials and processes that can increase the sensitivity of in-vitro diagnostics while requiring lower amounts of costly consumables,” commented Dr. Mario Blanco, NANOPEC CEO. “Our technology has the potential to save lives and lower healthcare costs by boosting bio-assay signals to significantly reduce false negatives from in-vitro diagnostics. We feel that we are heralding a new ‘gold standard’ that represents an important opportunity for the healthcare industry to increase IVD’s price performance and improve patient outcomes through earlier detection.”
Due to its nano-structure, and atomic composition, the fluorescence enhancement can lead to earlier detection by reporting lower biomarker concentrations. MetaFluorex requires fewer antibodies and biomarkers to achieve superior signal to noise ratios than comparable diagnostics on modified substrates (frosted, patterned, nitrocellulose or dielectric modified glass slides). NANOPEC’s patent pending process allows high-volume production at lower cost entry points than these related IVD glass technologies. The atomic structure of MetaFluorex has also eliminated a common problem present in biological samples that confounds some fluorescent signals, auto-fluorescence.
NANOPEC is committed to creating a new gold standard for in-vitro diagnostics that will ensure an accurate diagnosis with a goal of over 99 percent sensitivity to yield better patient outcomes:
- Improve performance in the IVD process by reducing erroneous readings through higher signal to noise ratios.
- Guide new IVD investments providing the intelligence to underpin informed decision-making.
- Improve patient outcomes by enabling earlier diagnosis and treatment decisions based on the ability to identify significantly lower bio-marker concentrations.