Markets

NTI will initially sell products and services for basic research and drug discovery applications not requiring regulatory approval. The technology is also well suited for biomarker validation, a rapidly expanding field driven by the paradigm shift towards personalized medicine. Lastly, NTI will target the large in vitro diagnostics (IVD) market, which is driven by worldwide increasing demand for diagnostic testing.

(i) Basic Research and Drug Discovery Markets (USD 1.5B; no regulatory approval required)
The ALEX technology’s unique single molecule analysis power allows to monitor molecular dynamics on the nanometer scale. The ALEX technology is highly useful in basic research for characterization of complex biological processes such as replication, recombination, transcription, translation, protein maturation, signal transduction, and others, in normal and disease states.

Moreover, the high-resolution power of ALEX to monitor molecular interactions and dynamics will also critically advance drug discovery and lead optimization through superior structure-guided rational drug design. Improved ALEX-based structure-activity relationship (SAR) studies involving molecules able to affect protein folding and misfolding, protein-protein and protein-DNA interactions, protein aggregation, as well as complex biological processes, such as assembly or disassembly pathways of multi-component complexes, will open a wide avenue for new approaches in drug discovery.

(ii) Biomarker Validation Market (USD 25B; no regulatory approval required)
Biomarkers are playing an increasingly important role in drug discovery and development from target identification and validation to clinical application. The paradigm shift towards personalized medicine relies heavily on the increased use of novel biomarkers to improve diagnosis, management, and treatment of disease. Reliable biomarkers thus are of critical importance for development of novel diagnostic tests. While the ongoing discovery of new biomarkers and their combinatorial use in panels is expected to significantly improve drug development and diagnostics across a wide spectrum of diseases, there is a large gap between biomarker identification and translation to clinical applications, requiring their validation.

As biomarkers can be both protein- as well as nucleic acid-based, the ALEX technology is particularly well suited as a biomarker validation platform through its multiplexing capabilities, detection sensitivities, as well as simple work flow, while requiring only minimal sample and reagent volumes.

(iii) In Vitro Diagnostics (IVD) Market (USD 50B; regulatory approval required)
NTI’s long-term goal is to develop simple, rapid, highly multiplexed (with a capacity of ≥100 analytes per sample), ultrasensitive and -specific, quantitative, cost-effective, and fully automated, nucleic acid- and protein-based syndrome-driven in vitro diagnostic tests. These will allow simultaneous detection and accurate quantification of multiple biomarkers, pathogens, and/or genetic aberrations in very small patient samples.

For entry into the fast growing global IVD market, NTI identified development of a highly innovative, next-generation blood-based prostate cancer test as the most promising opportunity. The cancer diagnostics market is on the verge of explosion as scientists approach major breakthroughs in tumor diagnosis and therapy. NTI will implement a panel of protein and microRNA (miRNA) biomarkers for improved diagnosis and population-wide screening, over-coming limitations of the currently existing popular PSA (prostate-specific antigen) test.