At The Point of Care
(Early Disease Detection and Screening, Rapid Diagnostics, Illicit Drug Detection, Therapeutic Drug Monitoring, ….etc).
In The Laboratory
(Hereditary Cancer Testing, Tumor Markers, Genomics, Proteomics,…..etc)
There is a Paradigm Shift Due to Skyrocketing Healthcare Costs that is Driving the Need for Point-of-Care (POC) and Consumer Self-Care Products To:
-Facilitate preventive medicine and early intervention while.
-Satisfying the Desire for privacy and Information Security in the Cloud.
Total Market Size $56.7 Billion*
Total POCT Market: Percent of Revenues by Segment (U.S.), 2016
Total U.S. POCT Market, 2016- $3.9 billion
Note:All figures are rounded: the base year is 2009. Source: Frost & Sullivan
Rapidly Growing Addressable Markets
A Fully Integrated System for Early Disease Detection and Effective HealthCare Monitoring at the Onset of the Disease, is a Highly Desirable Goal.
- Late stage diagnosis is 30X more expensive.
- Early Detection & Intervention Can Save Lives and Money.
- Provides One-Step Collection and Testing in the Field
- Provides the accuracy of the laboratory in the Palm of Your Hand
- The most hygienic Sample Collection and Testing Devices on the Market
- Initial Results can last for several months.
- Tamper Proof Design with One-Step Lockable Cap.
- Safe Storage as well as Shipping of lockable samples to distant locations
The goal for next generation assays is to achieve the sensitivity of a molecular technique coupled with the robustness, ease of use, simplicity, and cost of a lateral flow test strip.
Standard approaches to the laboratory detection of specific strands of DNA or RNA for diagnostic applications involve the application of inherently labor-intensive, complex workflow elements, many of which require automation and high levels of quality control, particularly in quantitative applications, to produce validated results.
Reducing this complex workflow to a simple disposable cartridge or simple set of easily-performed steps represents a huge challenge to the implementation of molecular tests at the POC. Doing so means addressing the fundamental way in which each of the steps in the workflow of a molecular diagnostic test is performed and integrated into a test device.
The World Health Organization Sexually Transmitted Diseases Diagnostics Initiative (SDI) developed the ASSURED criteria as a benchmark to determine if tests address disease control needs.
These criteria have since become widely applied as a useful benchmark for practical diagnostic technologies intended for use in most decentralized or rapid-testing environments. These key criteria are Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free, and Deliverable to end users.
Lateral flow technology remains the only widely available assay format that can address most, if not all, of the ASSURED criteria while also demonstrating flexibility of application and a capability for performance fidelity that approaches that of much more complex diagnostic technologies.
As a result of this unique confluence of characteristics, it is likely that this assay format will have a place in the rapid testing arsenal for many years to come.