There’s something irresistible about the "garage startup" -- passionate disrupters tinkering away in obscurity until, one day, they deliver a product that changes lives.  
 
Invisible Sentinel, a fifth-year resident of the University City Science Center Port Business Incubator, is one of those companies. In 2006, co-founder Ben Pascal was designing diagnostic devices for B. Braun Medical Inc. when he met future partner Nick Siciliano, a biomedical research scientist from Penn. Both shared a background in molecular biology and a hunger to start something new. Food safety, they agreed, was ready for new technology.

According to 2011 findings from the Center for Disease Control, foodborne illnesses affect one in six and cause over 3,000 deaths annually. Increased regulations and stringent requirements from national retailers have increased the need for better diagnostics.   

Despite humble beginnings -- the company started in Siciliano’s parents' house -- Invisible Sentinel has made a major breakthrough by inventing and commercializing Veriflow, a patented technology that revolutionizes food safety by making testing simple, inexpensive and accurate. In October 2012, Invisible Sentinel received the necessary regulatory approval from AOAC International and launched the first Veriflow test.

Invisible Sentinel and their products continue to gain the confidence of the investment community. On November 9 of this year, the company opened their fourth round of funding and surpassed their $1.5 million goal within 30 days. To date, they’ve raised $6.5 million from shareholders and angel investors exclusively. With each round, the company’s shareholder base has increased and many shareholders have become repeat investors.
 
"We’re true entrepreneurs," says Pascal. "We didn’t spin out of a university. We started with an idea, grew it, got the patents around it and validated the technology."
 
Currently, the upfront investment for molecular diagnostics testing equipment ranges from $40,000 to $100,000 and only trained scientists can properly read the results. Samples must be processed to remove microorganisms and other biological materials that interfere with testing outcomes (this step also requires a trained professional).

Lateral flow technology (used in pregnancy tests) is more user friendly. A liquid sample is applied to a test strip and flows horizontally, providing a positive or negative reading. While much easier to use, this method risks "back flow" and can lead to inaccurate results.

Veriflow technology, on the other hand, controls the flow vertically through a series of membranes. A farmer checking spinach for disease simply reads the screen. If one line appears, the spinach is ready for shipment. The process takes a total of 24 hours -- the fastest on the market -- and costs between $12 and $20 per test.

"We’re enabling people who couldn’t afford, or didn’t want to put the necessary investment in testing," says Pascal. "There’s not some big computer; you don’t need a scientist on your staff. I could train someone and within 30 minutes to an hour they’re up and running with a very sophisticated diagnostic."
 
In January 2011, President Obama signed the Food Safety Modernization Act (FSMA) which increases the authority of the Food and Drug Administration (FDA) to issue recalls. The law also requires agriculture to maintain food safety plans.  Effectively, everyone involved in your meal -- including farmers, processors and distributors -- is accountable for food safety compliance.  
 
Fortunately for Invisible Sentinel, the new law creates a larger market for molecular diagnostics. Veriflow’s ability to provide "actionable" results is a major boon for all levels of the food industry. Conventional testing methods require a 72 to 96 hour “test and hold” period. With perishable items, additional warehouse time cuts into valuable shelf life -- and profits. 
 
"[FSMAl] changed the rules for all the food manufactures," explains Pascal. "The entire food industry, for the past few years, has been going through a massive overhaul. It was the right timing for us to have a class of testing that answers that need."
 
As a self-contained operation, Invisible Sentinel outfitted their own pilot manufacturing facility, cell culture operations, and research and development team—all located at the Science Center. Their staff has grown to twelve employees and they expect to add ten more. Invisible Sentinel is currently in private beta with nationally recognized companies, including food retailers, third party labs and meatpacking plants.
 
2013 should be a big year for Invisible Sentinel: The company is releasing four additional Veriflow testing devices targeting specific contaminants—two strains of listeria, salmonella and pathogenic E. coli.
 
While providing cutting edge diagnostic devices for food safety is Invisible Sentinel’s priority, Pascal says there’s no limit to what molecular diagnostics can do. He believes many fields, including clinical health, veterinary medicine and anti-bioterrorism, could eventually benefit from Invisible Sentinel.
 
"You’ve got a handheld molecular diagnostic that’s extremely fast but super easy for anyone to use," says Pascal. "We’re going to go with those markets too and we’re going to see what happens. It looks pretty exciting."

DANA HENRY is Flying Kite's Innovation & Job News Editor.