Diagnostics & Imaging Week

A new color change assay developed by Beacon Sciences (Austin, Texas) may make routine kidney function assessments as simple and fast as taking a home pregnancy test. This could be especially important for surgery patients who often are given a kidney function assessment among a host of other routine preoperative tests.

Beacon says its technology has diagnostic testing applications for cardiac function, liver disease, kidney disease, diabetes, drug reactions and osteoporosis. The company believes the technology platform could be worth $50 million within the next five years.

The diagnostic assay is for the quantification of creatinine, a urine metabolite and universal indicator of kidney function, that changes color to the naked eye, Beacon said.

The new color change assay technology has been developed to work in a common lateral flow format, similar to a pregnancy strip test.

In one possible scenario of how the test might work, a patient would take it much like they would a home pregnancy test – or the test strip could be dipped into a urine sample – and the clinician would compare the color of the test strip to that of a standard card.

"In its simplest form, we could have a card that changes to a certain color and then you compare it with the test," Rob Hanes, a senior scientist at Beacon, told Diagnostics & Imaging Week.

"We can adapt it to a variety of surfaces, pregnancy strip test-type materials, or even do it in the solution, it's pretty adaptable technology," he said.

Alternatively, Hanes said, the assay can be analyzed for quantitative results in seconds using a miniature handheld reader technology that Beacon developed in conjunction with the assay.

As for the reader technology, he said there are two different scenarios: one, a handheld PDA-type device that could be used at the point of care; and two, a small USB-based machine, about the size of an electric pencil sharpener, that could be plugged into a computer for a bedside test.

Unlike existing assays, Beacon says it has created this assay using a synthetic receptor for this compound that replaces traditional enzyme and antibody based approaches. Many additional compounds can be detected using this method, which ultimately will allow more testing to be done at the point-of-care, physician office lab, and home settings, the company noted.

"We have an enzyme-free, antibody-free solution, our technology allows us to reproduce detection reagent in a way that is more durable than enzymes and antibodies," Hanes said.

Beacon believes its technology will offer simplicity and speed over conventional methods.

According to the company, the current global immunoassay market is $7 billion.

"We believe the color changing assay technology platform could be worth $50 million within the next five years if applied to the correct suite of novel biomarkers," said President Damon Borich, MD. "We focus on providing the core innovation and technology for the assay chemistry, but the first applications for consumer products may actually be seen in our spin-out company, Reveal Sciences, where we apply this technology directly in personal-care products and the cosmetics industries."

Both Beacon and Reveal are funded and managed by life sciences venture firm, Emergent Technologies (also Austin).

The unique features of the new product line stem from the assay's inherent ability to display visual color change as a result of the test, Beacon said. This, in combination with the handheld reader to give quantitative results, offers the potential of simplicity and speed over existing methods. In addition, the assay allows reliable samples to be taken from urine versus traditional blood and serum samples. The new assay technology can now be combined with existing assays already in the marketplace, and will allow the existing assays to more accurately predict kidney function and the effect it has on key metabolic markers.

"In essence, this technology has the promise to correlate more closely urine metabolite values with actual blood and serum values, thus offering a new means for non-invasive diagnostic testing," Borich said.