Background
Early Warning is a spin-off from NASA’s Ames Research Center in Silicon Valley. Over 30 employees and contractors are involved in development and testing activities in Silicon Valley, Canada and specialized US labs. Early Warning obtained an exclusive license for commercializing a nanotechnology-based biosensing platform invented by NASA to rapidly identify pathogens in space missions. The Company subsequently produced a more sensitive biosensor along with an on-board concentrator that enables processing of much larger samples than traditional methods and avoids the need for time-consuming polymerase chain reaction (PCR) or other amplification techniques. The Company developed its biosensor internally, with input and participation from engineers at NASA under a 5-year Space Act Agreement for product enhancements. The automated sampling system, concentrator and wireless communications were developed with a $2.3 million grant from Sustainable Development Technology Canada. The Company has engaged leading water organizations in Ontario for validation testing in winter 2009/10 in advance of a full North American roll-out.
Early Warning’s automated inline diagnostic biosensor is the first of its kind to rapidly and automatically detect pathogenic bacteria, viruses and parasites. The biosensor is initially targeted at detecting pathogens in water; with food solids, human testing and consumer products to be developed later. The Company’s automated biosensors have immediate applications in:
-
Water treatment plants and distribution networks
-
Food and beverage plants
-
Industrial and biotechnology plants
-
Point-of-use including hospitals and hospitality
-
Bioterrorism
-
Biotesting services
Trends impacting Water Testing
Pathogens and infectious disease kill 18.4 million people annually and sicken billions. The global population has increased by 4.5 billion new people in the twentieth century, and the continued growth in the twenty-first century has created an exponential demand for water, food, energy and other basic essentials. As demand outstrips supply of water and food, lower quality water sources with compromised standards are being increasingly used to avoid shortages. Examples include:
-
Toilet-to-tap water – Reclaimed water with raw sewage is increasingly added to drinking water where fully treated water is in short supply, such as Orange County, California. Severe weather can also divert raw sewage from treatment plants into nearby homes, businesses and industrial facilities. Examples include Hurricane Katrina in 2007, which caused contamination from salmonella, shigella, campylobacter, vibrio, hepatitis and flesh-eating diseases.
-
Toilet-to-fork – Wastewater potentially containing pathogens contaminated by animal manure or human sewage is being increasingly used to wash fresh fruits and vegetables, irrigate crops, fatten livestock, and as discharge near seafood sources. The increased use of imported food from unregulated countries such as Mexico and China is causing pathogen outbreaks in the US including a Salmonella Saintpaul outbreak in jalapeno peppers linked to 1,442 cases, 286 hospitalizations, and 2 deaths and as much as 40,000 unreported illnesses and $250 million in economic losses. Overcrowded conditions on factory farms are linked to Avian Influenza H5N1 virus or Bird Flu that caused the urgent culling of 3.5 million poultry in Saudi Arabia in 2007 and 2.9 million poultry in India in 2008 due to the fear of the strain mutating into a form more easily transmitted to people.
-
More high risk people – Aging infrastructure in urban areas due to decades of neglected repairs allow pathogens to enter the water supply from adjacent sewage lines. Cities and locations in arid regions are the locations of choice for the elderly and new immigrants whose immune systems are least able to fight off pathogens. Additionally, there is an increased number of aging and sick people who are most likely to get sick or die from ingesting a pathogen as was the case in a Cryptosporidium outbreak from tap water in Milwaukee in 1993 where 100 deaths out of the 400,000 that got ill were HIV patients.
Positioning of Biotesting Technologies
Historically, water industry participants have had to send their samples to biosafety laboratories for labor-intensive testing, or use alternative testing methods, which offer lower accuracy and lead to potentially costly ramifications. In ideal circumstances, water should be tested frequently for pathogens as it may only take 6 to 18 hours for drinking water to reach consumers. Because it can take several days or more to collect, transport, prepare, incubate, culture and interpret water sample for pathogens, contaminated water is highly likely to be consumed before the tests are completed.
Pathogens are tested in a capital-intensive biosafety laboratory using specialized equipment, costly materials, and labor-intensive processing under highly controlled conditions to ensure accuracy. These costs need to be factored into the test cost. Accurate diagnostic tests such as immunoassay or molecular PCR can cost from $100 to $700, but only one type of pathogenic bacteria, virus, or protozoa can be detected per test. Because of the high cost of testing a suite of pathogens several times a day at different locations, an indicator test using enzyme cultures of coliforms or indicator E.coli is typically used but cannot detect non-fecal bacteria, protozoa and viruses. Cultures cannot detect fecal bacteria that are temporarily injured from chlorination, or any pathogen that is not be captured in a relatively tiny 100 ml sample that is commonly used due to the limitation of transporting samples to the laboratory. As a result, water biotesting is compromised.
Continuous inline sensors such as turbidimeters measure micrometer-sized particles such as bacteria and protozoa along with rust and bubbles that give a quick screening of potential problems. As 99% or more of the bacteria found in water is harmless heterotrophic bacteria, sensors detecting their presence are not an effective substitute for a pathogen test. Early Warning’s inline biosensor provides a breakthrough in water biotesting for providing highly accurate detection of multiple pathogens with comparable time and cost of inline screening tests. An inline diagnostic biotest using molecular electrochemical technology can also allow government regulators to adopt more effective testing regulations as was done with chemical detection.
Early Warning is positioned as the world's first inline diagostic biosensor
offering both high accuracy of pathogen detection and rapid sample-to-test results
Early Warning’s molecular-based electrochemical biosensors significantly outperform today’s optical technologies with:
-
Diagnostic accuracy in detecting 10 or more specific pathogens per test rather than a single pathogen or indicator organism at the cost of an indicator test
-
Faster sample to test results in 2 to 3 hours – instead of 1 to 6 days – from a fully automated inline biosensing which removes costly factors including labor and human error
-
No major infrastructure cost by eliminating the need for a biosafety laboratory and associated equipment.