Consumer Diagnostics
Consumer Diagnostics
Introduction
The primary consumer based lateral flow assay is the over the counter pregnancy test, which constitutes a large component of the $2.1 billion dollar lateral flow test market. Other consumer based applications are growing in popularity, including tests for contaminants in food and beverages (e.g. caffeine), and at-home or in-store alcohol testing. Home drugs of abuse testing, and home-use infectious disease testing are growing applications in many markets. The lateral flow and flow through assay formats lend themselves well to consumer applications for a variety of reasons, including ease of use for untrained users, accurate results, and, if linked to an at-home or in-store reader system, can produce clear results that are interpreted accurately by the reader virtually 100% of the time. The linkage of reader systems to these tests also allow for new paradigms for use. Data can be stored on the readers, and used to monitor the patient’s status, either in real time, via connectivity, or at a later date after downloading by a medical professional. Depending on the application, if the reader is connected to the internet via USB or Bluetooth, the data can be stored, evaluated and used for certain commercial purposes, such as the delivery of notifications or coupons for the purchase of certain other products (e.g. flu remedies linked to influenza testing). Accurate market numbers for current consumer tests are not readily available, as the pregnancy test element of this market currently dwarfs other applications, however it is a new and growing area of interest for many companies.
| World LF Test Revenues (US$ millions) | |||||
|---|---|---|---|---|---|
| Sales 2005 |
% Mkt |
Sales 2010 |
% Mkt |
% CAGR |
|
| Clinical/OTC* | 1,880 | 90 | 2,725 | 89 | 8 |
| Veterinary | 175 | 8 | 270 | 9 | 9 |
| Food & Beverage | 25 | 1 | 50 | 1 | 15 |
| Pharma/Biologics | 10 | 0.4 | 20 | 1 | 15 |
| Environment | 5 | 0.2 | 6 | 0.2 | 4 |
| Water Utilities | 5 | 0.2 | 6 | 0.2 | 4 |
| 2,100 | 100 | 3,077 | 100 | 8 | |
| * Primarily pregnancy
Source: DCN Market and Technical Report: (Pushing Lateral Flow to the Limits) |
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DCN’s ability to create user friendly, easily interpreted, high performing tests, coupled with unique network of partners that allows us to customize device designs, iintegrate readers as appropriate, and manufacture the entire system in high volume at low cost make DCN your ideal partner for the development or manufacture of assays specifically for consumer use.
For a detailed discussion of market opportunities and appropriate technologies for lateral flow and flow through market segments, see DCN’s Technology and Market Report on the point of need diagnostics market, entitled Pushing Lateral Flow to the Limits. Contact us for information on how to order this report.
Advantages of lateral flow and flow through assays in this market segment
- Ability to handle multiple sample types, including food and beverages, whole blood, saliva, sweat, tears
- High sensitivity
- Quantification ability
- Ease of use by minimally trained or untrained users
- Low cost
- Speed
- Robustness and stability makes them suitable for home use
- Ability to transport and store without the need for refrigeration
DCN has developed numerous assays in this market area. Examples include:
- Semi-quantitative caffeine in beverages (coffee/tea/soft drinks)
- Bacterial assays for beer contamination (beer)
- Drugs of abuse tests (urine, saliva)
- Alcohol (saliva)
Developing or manufacturing assays for Consumer or OTC uses?
DCN offers a variety of products and services specifically designed to meet your needs, including:
Services
- Education and Training Course in Point of Care assay development
- Contract Assay Development
- Contract Manufacturing
- Custom Conjugation
- Consulting: Market evaluation, technology evaluation, regulatory affairs, manufacturing process development
- Packaging design
- Branding
- Device design for consumer use
Platforms for development:
- DiagnostIQ™
- ZAP
Reader Systems for lateral flow and flow through tests:
- Quantitative Handheld Reader
- Quantitative Benchtop Reader
- Qualitative Handheld Reader (The Visualizer)
- Quantitative Handheld Limited Use Reader
High Sensitivity Labels for Development
- Fluorescent particles
- Paramagnetic particles
- Colloidal gold