FDA Grants Breakthrough Device Designation for GenEndeavor’s Rapid Multi-Pathogen Test Panel for Bloodstream Infections

Breakthrough Device Designation provides expedited regulatory review for the RIM-Path ID Panel, a rapid bloodstream pathogen identification for patients with suspected blood stream infections, built on the company’s patented Isothermal Chain Reaction (ICR) technology platform

GenEndeavor LLC, a next-generation diagnostic assay development company focused on lowering the detection limit of pathogens and rare mutations, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Rapid Isothermal-Chain-Reaction Multiplex Pathogen Identification in Whole Blood Test, or RIM-Path ID panel. The test is designed to simultaneous detect and identify nucleic acid sequences from multiple known pathogen species directly from unpurified, uncultured human whole blood samples. The RIM-Path ID panel will test for more than 90% of bloodstream-infection pathogens and the most common resistance mutations in under 60 minutes using a patented, non-enzymatic, Isothermal Chain Reaction (ICR) technique that is instrument-agnostic.

Bloodstream infections (BSIs) are associated with significant risks of morbidity and mortality and significantly increased hospital lengths of stay. Current BSI diagnostic tests require up to several days to identify the causative pathogen species, delaying optimal antimicrobial therapy. In attempts to compensate for false-negative or inconclusive results and long diagnostic turnaround times in patients with suspected BSI, therapy is typically initiated using broad-spectrum antimicrobials before the causative infectious agents are identified.  This approach increases the risk of antimicrobial drug resistance and delays targeted treatments. Studies have shown that up to 40% of patients with bloodstream infections received ineffective therapy when broad-spectrum antibiotics were administered.

Timely identification of BSIs is also important in the diagnosis and treatment of hospitalized patients at risk of developing sepsis due to a possible BSI. Sepsis is a life-threatening illness that results from an infection that triggers a whole-body systematic inflammatory response. In the United States, more than 1.7 million people are struck by sepsis each year, accounting for 10% of all hospitalized patients and up to 52% of all hospital deaths. The high incidence of sepsis mortality is directly associated with a limited window of time in which to initiate effective antimicrobial therapy targeted against the causative pathogens. It is estimated that for every hour delay in administering appropriate antibiotics from the time a septic patient arrives in the Emergency Department (ED) to the initiation of targeted antibiotic treatment, there is an associated 10% increase in the 1-year mortality risk.

The availability of a rapid test that simultaneously identifies a large number of bloodstream infection pathogens from an unprocessed whole blood sample in under an hour with high sensitivity and specificity could transform the clinical management of patients with suspected BSI by significantly reducing the time to targeted treatment. Instead of a languishing for days on broad-spectrum antibiotics until a positive blood culture is achieved, treatment can start almost immediately with target-specific antimicrobials.

The RIM-Path ID panel will provide a more effective test for identification of pathogens in the bloodstream to aid in more rapid and effective diagnosis and treatment of patients with suspected BSI. RIM-Path ID will be the first non-enzymatic nucleic acid testing (NAT) assay technology, which means the absence of expensive enzymatic reagents, sample processing to remove enzyme inhibitors, and temperature cycling.

“Our goal is to address a critical and unmet global health need through the development of a new rapid test that can identify pathogen species in bloodstream infections directly from blood draws in under an hour with high sensitivity and specificity. The RIM-Path ID is intended to augment current bloodstream infection testing protocols with the aim to significantly decrease sepsis mortality, morbidity, and length of hospital stay.”

Ricardo Mancebo, Ph.D., Founder and CEO of GenEndeavor

According to the FDA, the goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to novel medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for regulatory clearance consistent with the Agency’s mission to protect and promote public health.