Electronic noses are familiar tools across a wide variety of industries with applications ranging from security to environmental oversight. But like their canine counterparts, special training is involved both for the handler and sensor, they can sometimes be awkward to use. And though often large in size, they may be sable to detect only one thing.

Additionally, both machine and beast must be fed – repeated recalibrations, for one, and kibble and bits for the other – to keep their sensing duties up and running well.

Incorporate the miniaturized finesse of nanotechnology, however, and you get a lightweight, hand-held machine that requires no special training, offers refined sensitivity and the ability to perform hundreds of tests consecutively (with no kibble of any kind needed for sustenance).

It can also check for a wide variety of substances.

Enter QualSec (North Logan, Utah), with its Nano-Nose, a device unique in many ways, but importantly able to analyze streaming air rather than just lab-controlled air samples.

"E-noses have been around for quite a while – there isn't a government agency or research institute that hasn't tried to produce an effective one," QualSec's CEO J.E. Hand told Medical Device Daily.

"But all previous attempts have been based on one of two technologies: gas chromatography or some sort of carbon-based chips that react by bending, like a home thermostat. For gas chromatography, you need a large machine and near-lab conditions. The carbon or synthetic chips are subject to moisture and other environmental conditions."

Previous approaches are also fundamentally flawed, Hand said, because able to test only for the presence of a single volatile organic compound (VOC).

QualSec's Nano-Nose uses photonic energy that bounces off of quantum dots, quantum dots being nanometer-sized semiconductors made of cadmium selenide, cadmium sulfide or cadmium telluride with an inert polymer coating. Because of their small size, quantum dots can function as cell- and even molecule-specific markers that will not interfere with the normal workings of a cell.

For the Nano-Nose, QualSec coats quantum dots with a compound that will react with whatever is being tested.

"They react to a laser light source and recording source that measures the reaction of the dot," Hand said. "We get a measurement of the presence of the element and the density instantaneously. We can also test for multiple VOCs at one time."

The potential medical applications are vast. Virtually any communicable disease as well as certain chronic diseases, such as lung cancer, could all be detected with the Nano-Nose.

Hand said QualSec is developing the Nano-Nose for a variety of uses, with medical and Homeland Security ranking at the top of applications out of the gate.

But he's cautious about surfing the unfamiliar (and seemingly shark-infested) FDA regulatory waters.

"We wouldn't yet strive to be a diagnostic tool, due to FDA constraints. We will offer it instead as a screening tool, first for tuberculosis."

The company instead will seek collaboration or partnership with an established med-tech, one willing to shepherd the Nano-Nose through the regulatory turbulence.

QualSec tested a benchtop prototype last year that fit inside a briefcase. But now the company is developing a hand-held model the size of a CD player.

"We have located and collaborated with outside manufacturers to make every component of the Nano-Nose," Hand said. "We also have a parallel track developing related software. It's all about 90% completed. We think we could have it ready to commercialize within three to six months from the start of a collaboration to production. We do have some joint collaborations already in process for food processing, which is probably the largest market, but the medical applications and Homeland Security seem the most exciting."

Hand said he also is in negotiations with three yet-to-be-disclosed "leaders in their respective fields" for a medical application.

What's also unique about the machines is that it's easily interchangeable for different industry applications.

"We could easily switch from screening for TB to screening for ammonia, which is indicative of spoiled fish," Hand said. "It's just a matter of the coatings on quantum dots and the sort of receptor we have: either a mouthpiece for patient to blow into or something to collect ambient air."

Hand said he believes that no other company is developing an e-nose based on nanotechnology. QualSec owns the IP, which was developed internally and the Nano-Nose is the company's only product.

At a potential price of $2,000 to $3,000, it's an affordable solution for disease screening.

If a potential partner wanted to take it to the level of a diagnostic, "It wouldn't be a big leap in R&D to raise it to a diagnostic," he said. "The basic technology will be universal."

Launched just last year, QualSec's leaders didn't want to negotiate the difficulties of fundraising via venture capital or angel investors. So they went public right out of the gate.

The company raised net proceeds of $113,401 in a Regulation A offering and then obtained a $200,000 loan provided by an officer and director. The remaining portion of the offering was sold in January 2008 for proceeds of $185,500, which was used to repay the loan in part.

"We have cash on hand and funding commitments for two additional quarters," Hand said. "If we could obtain more funding, we could add more staff and speed up our production cycle. But we've been more focused on development. Now we're at the stage where we would seek additional funding."

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