Your number one corporate objective in 2018 is to build a rapid assay for a critical application. You’re in charge.
Maybe it’s a test for use in malaria eradication programs. It has to be qualitative, single-plex, fast, analytically very sensitive, scalable, easy to use by untrained users and have extremely high clinical predictive value.
Or maybe it’s a test for cardiac or cancer biomarkers. It has to be multiplexed, quantitative, for use in doctor’s offices, emergency rooms or ambulances. It has to be easy to use, coupled with a digital reader, designed with the stressful application in mind with user centric design, performance and branding as key specifications.
Or you might be working in veterinary, pharmaceutical, agricultural, food, bio-defense or consumer testing markets and need devices designed specifically for the unique needs of your users and markets. For example, a test for protein conformation in a bioprocessing plant.
It should be easy to find the right platform, right?
Then you realize that the product needs to be in market in less than two years for a reasonable cost of development with low cost of goods. It has to perform better than the competition and lab based predicates. You don’t want to operate in a restrictive IP environment. You also don’t want to risk pioneering basic development of a novel microfluidic platform or detection technology.
OK, well the platform options just became more limited.
So what do you do?
How Do You Hit Your Rapid Test Product Development Objectives with Lateral Flow Technology?
Maybe you’ve never heard of lateral flow technology. Or maybe you’ve heard of lateral flow in connection with simple pregnancy tests but don’t think it’s suitable for your complex application. After all it’s only a cheap solution to easy problems, right? And your problems are not the easy ones.
It’s not surprising that you may be unaware of lateral flow technology, or that you may be unaware of its actual capabilities.
You’re not alone.
Lateral flow is a 30-year old technology that is best known for use in pregnancy and fertility tests for consumers. Pee on a stick and get a yes or no answer. Early products were often not designed for use and required cumbersome processing by the user. They were limited in their ability to multiplex or quantify, so they were limited in application.
When you think of modern, user-centric diagnostic technology with high accuracy for tough challenges, you don’t automatically think “lateral flow technology”. That’s a pity, because you’re likely thinking of what lateral flow was 30 years ago, not what it is today. The technology has moved on. The industry, however, has not done a great job of making you aware of what lateral flow technology can do. We’re sorry for not bringing this to your attention before now.
We want you to hit your objective for 2018 so here are some things to know:
Lateral flow technology is in many cases the only rapid immunoassay platform technology that can meet your product’s needs.
Here are some examples of things you may not know about lateral flow technology that might provide the answer to your product development challenges:
1. Multiplexing and Quantification: It’s very possible. For example, Astute Medical’s NephrocheckTM assay system for two biomarkers indicative of acute kidney injury (TIMP-2 and IGFBP-7) is FDA approved, commercialized and is saving lives today.
2. Robust, Field Deployable, Quantitative, Digitally Integrated Platforms Designed Specifically for Use: It’s been done. For example, the Biodosimeter platform, developed with SRI International under funding from BARDA, is a fully quantitative 4-plex biomarker assay system intended to assess radiation exposure in the event of a nuclear incident. Whole blood from a fingerstick is assayed in a single step for up and down regulation of 4 biomarkers using a lateral flow assay. The assay is interrogated by a robust digital assay reader that is connected locally and to the cloud.
And the best part – all of this is in a system designed for ease of use for personnel wearing full Personal Protective Equipment (PPE) in a high stress, low resource, uncontrolled environment for testing of mass populations. A truly unique test system that – if it is ever needed (hopefully it’s not!) – will save a lot of lives.
3. High sensitivity, low cost, highly scalable assays for infectious disease diagnostics: Hundreds of millions of tests are produced annually in lateral flow format for these applications. For example, the next generation of malaria tests, which will have to be extremely low cost and highly scalable to hundreds of millions of units annually, will need to detect only a few organisms in an infected individual. This is being achieved using highly sensitive lateral flow assays. Several organizations are working with DCN and other companies to develop and transfer these highly sensitive assays to large scale production and deployment. Another lateral flow product that will save millions of lives over time.
4. Low Cost of Development and Speed to Market: Lateral flow is an established, proven technology. There is very little basic research involved in the development of a lateral flow product. The fundamentals of the technology are well understood. The entire supply and manufacturing ecosystem is in place. It’s primarily Development rather than Research once your target and your reagents are understood. Most lateral flow products can be developed and transferred to manufacturing significantly faster and cheaper than microfluidic or lab-on-a-chip-type products. This increases the attractiveness of the risk profile of the program.
5. Regulatory and Market Recognition: After decades of proven performance lateral flow is an accepted technology.
6. Uncluttered IP Space: The IP space is – relative to microfluidics and molecular diagnostics – relatively unrestrictive.
7. Enormous versatility in application and sample type: Lateral flow assays have been developed for many applications involving an enormous array of sample types. Application areas include:
a. Human clinical diagnostics: Using blood, plasma, serum, urine, sweat, feces, cerebro-spinal fluid, interstitial fluid, nasal swabs, vaginal swabs, wound fluids, saliva, semen, skin cells
b. Veterinary diagnostics: Using the same array of samples as clinical diagnostics
c. Female Health (Fertility and Pregnancy): Using urine, saliva, blood, vaginal secretions
d. Environmental testing: Using water, soil samples, air samples, powders
e. Chemical industry testing: Using bulk fluids and surface swabs
f. Pharmaceutical manufacturing: Using in-process manufacturing materials and reagents and finished product
g. Companion diagnostics: Using the same array of samples as clinical diagnostics
h. Consumer wellness testing: Biological fluids, breath, skin samples, swabs
i. Agricultural testing: Plant materials, soil samples
j. Food pathogen testing: Food samples of all kinds, solid and liquid, raw and prepared. Also food-chain safety testing for adulterants, hormones, pathogens etc in animals and vegetables.
k. Bio-defense: All kinds of biological fluids, air samples, soil samples, bulk liquids, powders
l. Chemical defense: All kinds of biological fluids, air samples, soil samples, bulk liquids, powders
m. Industrial health and safety: Surface swabs, air and bulk fluids
Now you know, tell us how we can help you
If you need to develop a rapid test in 2018, we hope you think seriously about lateral flow, no matter what market segment you are in. At DCN we strive to stay at the forefront of the technology and to develop the most ground-breaking applications using this platform. Let us know what challenge you are trying to address and we’ll tell you if it’s possible using lateral flow technology. Often it is. If it is, we’ll work with you to educate you on the best technology options and on the process of getting your product developed. We can then fully develop your product and transfer it into manufacturing for you under our ISO 9001 and EN 13485 compliant quality system.
Email or call us to find out more about lateral flow technology, DCN and why this is actually the rapid diagnostic platform you need. Check out our YouTube channel for some related videos.
About DCN Diagnostics: DCN Diagnostics is a full-service development company devoted to developing, validating and transferring to manufacturing all aspects of a lateral flow platform, including reagents, assays, cassettes, sample collection and handling devices and reader systems for any application.