February 21, 2019

The BARDA DRIVe Solving Sepsis initiative is partnering with Qvella Corporation of Carlsbad, California, to develop ground-breaking technology to diagnose infection in patients suspected of sepsis with assay results in 60 minutes. The new host response diagnostic system leverages Qvella’s FAST-ID™ pathogen identification platform based on revolutionary new approaches to rapid sample processing and nucleic acid isolation and amplification directly from whole blood.

The ability to diagnose underlying infection and septic patients rapidly and accurately is a critical factor in saving lives, improving patient outcomes and making better use of healthcare resources. Sepsis is a serious public health threat, killing an estimated 270,000 Americans each year and incurring high healthcare costs. Sepsis would pose an even greater health security threat in the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication of influenza or other infectious diseases.

Sepsis occurs when the body’s efforts to fight an infection results in a dysregulated immune response and inflammation that can cause tissue damage, organ failure and death. Sepsis is difficult to diagnose and distinguish from other inflammatory conditions and currently can take days to accurately diagnose.

The Qvella project combines the company’s diagnostics technology and expertise with Predigen Inc.’s gene signature analytical power to help develop the intended assay for the early diagnosis of sepsis.

DRIVe (Division of Research, Innovation, and Ventures) supports the development of innovative products and approaches that aim to solve major health security challenges through innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority) within the U.S. Department of Health and Human Services.

DRIVe and Qvella are committed to a public-private partnership, with DRIVe contributing $692,236 of the total $988,909 estimated project cost. Qvella will fund the remaining development costs.

DRIVe is transforming the speed in which government partners with industry. To streamline its funding mechanism, DRIVe implemented a new EZ-BAA application, a business-friendly simple abstract.


C O M P  A  N Y    D E S C R I P T I O N    ( P  R O  V I  D E D    B Y Q V E L L A )

Qvella is a molecular diagnostics company founded in 2009 by a group of scientists and engineers with the goal of dramatically reducing time to results in bacteriology. The company aims to revolutionize how sepsis management is practiced  by  significantly cutting costs and saving lives. Qvella’s Field Activated Sample Treatment (FAST) technology utilizes a novel sample prep technique that enables rapid  detection  of infectious agents and  host  response biomarkers from  whole blood.  When implemented   in concert with Antibiotic Stewardship programs, now being adopted by most major medical centers, timely clinical decisions can be made which lead to improved patient outcomes, reduced hospital stays, lower  side  effect  profiles,  and a  significant reduction in treatment costs.

C O M P  A  N Y    D E S C R I P T I O N    ( P  R O  V I  D E D    B Y P R E D I G E N )