Executive Summary

The nature of health care is changing. The trend is towards lower cost, preventive, and personalized medicine.  Testing procedures by life sciences companies like Quest and LabCorp are done using a relatively large volume of blood, and results are delivered over a week.   Thus, although necessary for a full health profile, these bioassays cannot currently be integrated into timely monitoring of trends such as improvements and decay in health.  

 

Bioassays are fundamental to both life science research as well as diagnosis and treatment of diseases and medical disorders. Life scientists and clinical laboratory technicians perform bioassays in a variety of different test “formats”. Bioassays may be microplate-based (common for antigen-antibody binding assays or receptor ligand binding assays), microarray-based (common for analysis of DNA fragments or detecting the presence of specific proteins and peptides), test-tube based or micro-fluidic “lab on a chip” based.  They are typically employed to, among other things:

  • characterize the mode of action and metabolic effects of candidate drugs in research & development

  • identify genetic profiles that may increase a person’s susceptibility to inherited disease

  • detect and quantify chemical or biological compounds (“analytes”) of interest in patient body fluid samples (example: infectious agents, cancer markers or hormones), and

  • enable physicians to establish and maintain treatment regimens that optimize therapeutic effect.

 

iFluidics technology represents a paradigm shift in biochemical assay testing (BAT). The iPlate Platform/iPlate combination revolutionizes microplate assay performance with up to 15-fold reductions in incubation times (from hours to minutes, enabling rapid laboratory processing), coupled with up to 25-fold reductions in sample volume that result in reductions in reagent consumption that lead to testing cost reductions of up to 80%. Dramatic improvements in assay sensitivity have also been observed in a joint study with Merck Pharmaceuticals.  

 

The captive and consumable iPlate is American National Standards Institute and the Society for Laboratory Screening and Automation (ANSI-SLAS) compliant, and is 100% compatible with existing laboratory equipment and processes in both research and diagnostic operations; enabling the iPlate Platform to integrate seamlessly into high-throughput screening (HTS) operations.  The iPlate platform software is programmable to deliver assay-specific electro-kinetic stimulation to optimize sensitivity, reduce incubation time, and provide up to 80% reduction in a cost-per-well for 96- and 384-well microplate assays.  

 

The iPlate Platform technology is ideally suited to point-of-care (POC) applications. However, Integrated Fluidics, Inc. (iFluidics’)  strategy is to demonstrate the attractiveness of the platform in life sciences applications in the US/Canada markets, launching first in the unregulated research market, shortly followed by the diagnostics market once FDA 510(k) certification is achieved.   T

 

Over 10 billion tests are conducted annually in over 170,000 laboratories, clinics and doctors’ offices around the world. Major categories of testing include routine chemistries ~12% , immunoassays ~22%,  glucose tests for diabetics ~23%, cellular analysis ~14%, conventional microbiology tests ~7%, and molecular diagnostic tests ~10%.   The research market share of development of new and improved  immunoassays and cellular analysis provides a large target for initial penetration; and with already proven iPlate Platform efficacy in the diabetes A1c assay, the diagnostic market, post FDA certification, is even more promising.  

 

Based on the current market sizes for the life sciences research and diagnostics markets, iFluidics conservatively projects exceeding $15 million in gross revenue with a cash flow break-even by the end of year three post-launch, and expects to have over $100 million in gross revenue within five years gaining an approximate 5% market share of 96-well and 384-well microplates.  Subsequent expansion into vertical and horizontal markets (including POC) totaling hundreds of millions is expected in year six and beyond. We will initially launch into first, the US/Canada life sciences research market followed closely by FDA certification and launch into the US/Canada diagnostic market.