At the core of MDx are nucleic acid-based technologies for sample preparation, nucleic acid target capture, amplification, detection and analysis. The factors currently driving MDx are better, faster, cheaper assays combined with point-of-care, point-of-use, multiplexing, and quantitation applications.
The application of PCR methodologies includes research, MDx, Next Generation Sequencing (NGS), and clinical diagnostic markets. The global PCR market is expected to reach $9.8B by 2021. This is a market that is directly relevant to AEGEA’s patented next generation nucleic acid technologies. For example, Aegea’s patented Switch-Blocker constructions can be used to detect rare mutations associated with cancer and other diseases. In combination with Q-PCR, the Switch-Blocker technology can be used to detect extremely rare genetic events at a prevalence of less than 0.01% even in a vast background of complex genomic wild-type/normal DNA.
Thanks to huge advances in NGS technology and instrumentation, including dramatically increased speed and reduced cost, the application of NGS to MDx is becoming increasingly attractive and anticipated. This increases the opportunities for AEGEA’s technical solutions and intellectual property.
There is also a focus on ease of use, greater automation, and the ability to use less skilled labor to perform an assay whether automated or not. Many of these factors are being linked into next generation sequencing, particularly in the areas of biomarker discovery and multiplexing. AEGEA technologies are being applied in combination with NGS to enable multiplexed MDx assays that provide high sensitivity results across a broad range of medically significant target sequences for a variety of clinical indications.
The real-time PCR market, which includes kits, fluorescent detection methods and instrumentation, is growing rapidly, and is an increasingly important segment of the total PCR market. The PCR market includes a combination of instrument, reagents, and software analysis tools.
These opportunities provide a unique combinations of technologies that improve both MDx assay capabilities, and at the same time facilitate improvements to whole transcriptome and whole genome amplification, library construction, and amplification improvements associated with NGS. The Aegea Switch-Blocker technology has already been used to increase the sensitivity of rare mutations associated with cancer by more than 20,000 fold.
Sign up to hear from us.