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Advanced Animal Diagnostics Entering Human IVD Testing for Severe Infection


NEW YORK ─ Advanced Animal Diagnostics is entering the market for human point-of-care testing with a hematology analyzer it believes could match the performance of laboratory-based systems for detecting the risk of severe infections like sepsis.

Under a recently announced $733,000 contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority, the Morrisville, North Carolina-based company is modifying an analyzer it has commercialized to help farmers curtail the overuse of antibiotics in livestock.

The funding builds on a $7 million raise, announced in May, by AAD to support the commercial expansion of its livestock tests and a US Food and Drug Administration 510(k) submission for its human blood test.

The BARDA project marks AAD's expansion into human in vitro diagnostic testing and is intended to provide the information and data the firm needs to apply for FDA clearance, the firm's CEO Joy Parr Drach said.

The hematology analyzer, called the QScout RLD+ system, has the potential to detect the risk for severe infections, such as sepsis, in less than two minutes, according to AAD, which intends to first target urgent care clinics and doctors' offices, among other point-of-care settings.

During the development of tests for animals, AAD had identified immature infection-fighting cells as markers for the progression to sepsis in humans, and that led it to the development of a system for human testing and the BARDA grant, Parr Drach said.

To detect that a patient is at risk for a severe infection, laboratory analyzers enable the automated counting of five varieties of white blood cells — neutrophils, lymphocytes, monocytes, eosinophils, and basophils. AAD's point-of-care hematology analyzer includes measurements of those varieties as well as two categories of immature cells, leading to a seven-part leukocyte differential and more in-depth clinical information, Parr Drach said.

The differential includes the quantification of band neutrophils and other immature granulocytes — processes normally completed in the lab, she said.

When a patient is suffering from a serious infection, such as sepsis, mature neutrophils are depleted and neutrophil bands are released. Following that, immature granulocytes are released, and the analyzer detects an increase in automated band and immature granulocytes, according to AAD.

Such hemograms — complete blood counts used as screening tests — are often the first tests physicians order for a patient with suspected sepsis, said Tim Sweeney, cofounder and CEO of Inflammatix, which is developing rapid host-response tests for sepsis and other indications that use gene expression biomarkers.

The AAD test appears to be "differentiated with a seven-part differential, in particular focusing on immature neutrophils, or bands, and immature granulocytes," said Sweeney, who is not affiliated with the company.

However, physicians and their patients need to know not only whether there’s an infection but also the type of infection, including whether it is bacterial or viral. The "concept of bands and immature granulocytes are potentially useful for stratifying risk, but don’t help establish whether a patient is suffering from infectious or noninfectious inflammation," Sweeney said.

As a result, markers of infection severity and risk, such as bands or lactate, are the first part of working up a patient with suspected sepsis, he noted.

Following that, patients will often also need microbiological tests, such as blood cultures, or in vitro diagnostic tests that seek to identify a pathogen when possible. Further, antimicrobial susceptibility tests are often used as part of the diagnostic workflow to detect whether a pathogen will respond to a specific therapy.

Some biomarkers are useful for diagnosing an infection, while others are useful for estimating risk, but ultimately "both diagnosis and prognosis are necessary early in the workflow," Sweeney said.

AAD's QScout RLD+ system is small enough to sit on a desktop and is being designed to be broadly available as a first line of detection for the severity of an infection, Parr Drach said.

The system under development can be powered by a battery and does not require reagents to be refrigerated, so it could be used near patients in areas that lack an electric power supply and refrigeration, she said.

It operates using a fingerstick of blood or whole blood and involves plugging a palm-size portable card that consists of dried reagents into the analyzer. The reagents stain the blood cells, and the instrument's microscope interprets the stain as an indicator of the severity of an infection.

AAD, founded in 2001, has commercialized two rapid tests for animals that run on its portable reader. One test provides results in 32 seconds to guide whether livestock need antibiotics and predict the risk of mortality. Users of the test have reduced their use of antibiotics by up to 60 percent and are saving about $250 per infected animal by finding the infection earlier, according to Parr Drach.

Another test detects early signs of mastitis, a condition typified by an inflammatory reaction of the udder tissue that can be fatal.

For clinical trials using human samples, the firm is comparing the results of tests using its instrument with the results of laboratory tests of the same samples by Laboratory Corporation of America, one of AAD's investors.

Its tests for livestock cost between $5 and $7, and its instrument costs $18,000. They can also be leased. The firm has not priced its human sepsis test, Parr Drach said.

Numerous companies are already selling complete blood count analyzers for use at the point of care. Among them, the OLO system, developed by Tel Aviv, Israel-based Sight Diagnostics uses digital fluorescent microscopy and machine-learning algorithms to capture and analyze images of blood drawn from a finger prick.

Further, Yokneam Ilit, Israel-based PixCell markets HemoScreen, a point-of-care blood testing platform that conducts blood cell analysis within five minutes using artificial intelligence-based microfluidic and lab-on-a-cartridge technology. According to PixCell, HemoScreen conducts five-part differential complete blood count tests and produces results equivalent to laboratory analyzers by applying a microfluidics method called focusing to conduct cell analysis.