The innovative firm Alverix has begun clinical trials with two development partners to support FDA 510(k) submissions for its versatile testing instrument.

Alverix develops and manufactures instruments for point-of-care (POC) testing for things like the flu or drugs of abuse in employment screening. The company's hand-held devices have many other potential applications also and promise the functionality of much larger and more costly bench-top lab equipment.

The company's intellectual property has quite a pedigree with notable scientists including optical mouse inventor Tong Xie on the company's development team. Alverix is working with various development partners to serve broader POC markets with an instrument platform based on optical electronic image acquisition.
"Essentially we take a picture of the test site and use software, firmware and algorithms that analyze that picture to determine if the picture is normal or abnormal," explained CEO Ric Tarbox. "We can look at any sample--blood, urine, a swab from the back of the nose for flu testing, any bodily fluids."

The image-based technology also incorporates powerful real time wireless data management. This can be used to track epidemics, or incorporate into patient records or even business records.

"Think about a situation where in the future you want to do a test at home. Let's say you have a chronic disease and you have to test yourself regularly. You use the device at home and do the test. It might take 3-10 minutes depending on the incubation in the test. And then as soon as the test is done, it's sent securely to a computer and to your physician," Tarbox said.

The timely reporting can support timely treatment. The data can also populate hospital and billing systems. And there are business implications for this type of instrument self-reporting of their usage.

"It also could help with compensation for sales reps. Manufacturers today sell through large distributors and at that point they lose track of where their product is because those large distributors ship it around the country and then to the end users," Tarbox explained. With our system they would have real time access to test utilization data by instrument."

Customers for the futuristic devices include hospitals for bedside testing or ER, outreach clinics, physicians' offices, convenience clinics such as in chain pharmacies, and ultimately the patient's home. Another application would be in international markets for field health screenings in developing countries.

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