Diagnostics, Devices & Diagnostics

A point-of-care company with handheld test device is taking on Abbott, Alere

A California company with 10 employees is taking on the likes of Abbott, Alere, in the point-of-care diagnostics market with a new handheld, portable sepsis testing device.

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While Abbott and Alere are duking it out in court, an Emeryville, California firm aims to take on these established, point-of-care diagnostics companies through what an executive believes is a more accurate, precise tool.

Nanomix is developing a handheld, mobile, point-of-care diagnostics device able to deliver results of a sepsis test within 10 minutes compared with central lab tests that might take hours. The system, or eLab, consists of a handheld reader, and an assay cartridge with a carbon nanostructure biosensor.

Using a single patient’s blood sample, the device can provide analysis for lactate, PCT and C-Reactive protein to determine whether a patient has sepsis.

“There isn’t anyone doing what we’re dong in sepsis or some of the infectious disease areas,” said David Ludvigson, CEO of Nanomix, in a recent interview in San Francisco.

Nanomix expects to run and complete a clinical trial of the device with the sepsis test by the summer and file for CE Mark this year, Ludvigson said. The hope is to launch the test and device next year in the U.S. Nanomix has already participated in several pre-submission meetings with the FDA. Clinical trials for another test — troponin (a biomarker for heart attack) — have already taken place. The diagnostic device has been tested in about 2,000 patients. In some cases, the data has been compared with central lab testing equipment such as the Siemens Centaur to test eLab’s accuracy and specificity.

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The eLab handheld diagnostic device

“This is a really central lab system boiled down into a very small package,” Ludvigson declared. “There’s heating capabilities, pneumatics, pumps, all kinds of things, Bluetooth. What we really look at is the ability to put in the hands of healthcare provider a decision-making tool that will help inform the decisions about immediate clinical intervention.”

Enhancing the decision-making power is exactly what Abbott and Alere say they are doing as well, but Ludvigson described the point-of-care products of the market leaders as stationary and not really meant to be portable.

That goes against what Abbott touts regarding its iStat system, which includes a handheld device into which you insert cartridges to run various tests.

But Ludvigson seemed to imply that the iStat device is handheld only in name.

“The Abbott iStat handheld model’s use is restricted to being run while on a flat surface, without movement,” he contended. “I don’t think of that as ‘mobile.’  It is stationary.”

That same device is able to perform both a sepsis test and the troponin test, confirmed Rachael Jarnagin, a spokeswoman for Abbott Diagnostics, in an email.

“Our i-STAT handheld, point-of-care lactate test can help doctors diagnose hyperlactatemia, an indicator commonly used to detect low tissue oxygen levels – as in the case of sepsis,” Jarnagin wrote. “When sepsis is suspected, being able to detect hyperlactatemia within minutes could allow for quicker treatment decisions.”

But while Ludvigson allowed that Abbott’s troponin test is “one of the better point-of-care” troponin tests on the market, he critiqued the company’s sepsis test as well as other similar tests for their over-reliance on high lactate levels.

“The bias today is to put patients on these sepsis protocols, which are pretty rigorous and they do this on the basis of the one lactate test,” he said. “By the way, you may have elevated lactate if you went up and down a couple of flights of stairs.”

What Nanomix’s eLab does instead is run tests not just on lactate levels but for other biomarkers like PCT and C-Reactive proteins.

“By adding markers associated with infection, our panel adds specificity to the patient information,” Ludvigson said. “Further, the use of these additional assays is consistent with recommendations in the Surviving Sepsis protocols.”

Nanomix knows a thing or two about surviving.

The company was formed in 2001 as a spin out from Berkeley Labs, Ludvigson said. It had one major corporate client around 2008 that was using Nanomix’s nanosensor. But when that company pulled the plug on the project because it ran into financial trouble, it spelled near doom for Nanomix, he said.

Until the company’s primary investor — Gruener Ventures — came to the rescue. Gruener Ventures is named after Garret Gruener, a cofounder of Alta Partners, a venture capital firm, who is also the founder of Ask.com (previously known as AskJeeves.com).The sensor technology was leveraged to create the eLab to create the company’s current incarnation.

Aside from Gruener, others see value in the technology too. Physio-Control, owned by Stryker and in the business of providing equipment like automated external defibrillators for emergency responders, has a 10% equity stake in Nanomix, Ludvigson said. The company also has the rights to distribute the product to its customers once regulators clear it.

Aside from the $48 million invested in Nanomix’s first life, the company has raised $30 million to date and expects to raise another $5 million shortly, Ludvigson offered.

Nanomix’s success will be dependent on how successfully it can argue the case for a new technology in a value-based care environment. But Ludvigson has a ready answer for that.

“The reimbursement on that is $65 per test for the sepsis screen and we look to sell our device at $15,” he said.