AAD awarded contract for better blood count, sepsis diagnostic system

Ad Astra Diagnostics (AAD) of Morrisville has been awarded a $5 million federal contract for the development of an improved diagnostic system to deliver faster complete blood count (CBC) test results and the earlier detection of severe infection, including sepsis.

The contract, awarded by the Biomedical Advanced Research and Development Authority (BARDA), has the potential to reach $12.6 million, the company announced in a news release.

AAD’s QScout CBC diagnostic system is intended to yield the most comprehensive patient-side CBC results and the first to report immature granulocytes and neutrophil-to-lymphocyte ratio in community settings, such as physician offices, cancer centers and ambulances, for earlier identification and triage of severe infection.

“Coupling a full CBC with a sepsis risk score on a small, simple and rugged platform expands the market and increases access to on-site critical testing and early identification of severe illness and sepsis to help prevent unnecessary deaths from infection,” said Joy Parr Drach, chief executive officer of AAD. 

“Every hour matters when it comes to protecting patients with infection, but today there are few tools available to aid early diagnosis before patients arrive in a hospital setting,” Drach added. “We are extremely gratified that AAD’s vision for an improved life-saving diagnostic system has received substantial financial support from BARDA.”

The QScout system is being developed as the next generation of the company’s QScout RLD, which earned 510(k) clearance for sale from the U.S. Food and Drug Administration in 2023 after successful field trials that compared it to central lab tests.

QScout RLD (Rapid Leukocyte Differential) reports a white blood cell and differential count at patient-side in about two minutes from a drop of blood. Results include immature infection-fighting cells that some labs count manually. 

QScout RLD development was also funded in part by BARDA, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

‘Lab in a box’

The QScout CBC system will feature many product enhancements such as a smaller size and expanded diagnostic capabilities, including quicker and easier CBC testing. The new system is essentially a “lab in a box” that contains a computer, microscope, camera and robotics. 

To perform a test, a user places blood from a finger stick or venous sample onto a low-cost test cartridge and inserts the test into the QScout Lab. No sample preparation is necessary. The system then uses artificial intelligence-trained algorithms to identify cells and cellular parameters and return a test result in about two minutes.

“We are excited to see this important tool funded to help us with the holy grail of testing: get patients to and through the emergency department faster if they need to be there, and keep them out if they don’t,” said Jon Baker, director of laboratories at the University of Michigan Health - Sparrow, one of the locations involved in testing the system.

The complete blood count is one of the most ordered diagnostic tests and a first line of triage. It screens for a variety of conditions ranging from infection, sepsis and anemia to cancer and internal bleeding.

The QScout platform, which has received 11 patents to date, uses an imaging-based system with artificial intelligence to avoid the challenges of flow cytometry, a laser-based lab test that detects chemical and physical differences of cells with indirect measures such as light scatter or electrical resistance.  

AAD develops rapid point-of-care diagnostics and data systems to enable fast health decisions. Ad Astra’s name, the Latin translation of “to the stars,” embodies the company’s vision for democratizing diagnostic access and pays homage to imaging techniques rooted in astronomy.  

The company is the human health subsidiary of Morrisville-based Advanced Animal Diagnostics, which received early grant and loan assistance from the North Carolina Biotechnology Center to develop QScout diagnostics for use in cattle.