HelixBind has secured the US Food and Drug Administration (FDA) breakthrough device designation for its RaPID Sepsis test, called RaPID/BSI.
RaPID is a direct-from-blood platform developed to detect and characterise bloodstream infections. The RaPID/BSI test is designed to identify the ‘most common’ bloodstream infections associated with sepsis.
Sepsis occurs as a result of the drastic immune response to a bloodstream infection. Approximately 1.7 million cases are reported in the US, while over 270,000 patients die from sepsis every year.
Quick and precise identification and characterisation of the infection is vital to help physicians begin the necessary antimicrobial treatment as the prognosis for septic patients deteriorates hourly.
HelixBind said that the RaPID/BSI offers unambiguous identification of bloodstream infections direct from the blood within hours, while existing methods take days.
It will enable the physician to select appropriate antimicrobial treatment for the patient.
Additionally, the test covers a large panel of 21 bacterial and fungal pathogens and has high sensitivity to identify very small concentrations of pathogens contained within a blood specimen.
HelixBind CEO Alon Singer said: “We are thrilled to receive the breakthrough device designation as it is a strong validation of the work we are doing at HelixBind.
“We look forward to continuing our dialogue with the FDA and following its guidance to ensure RaPID/BSI is safe and effective, significantly improving the lives of countless individuals afflicted with sepsis.”