FDA Grants Breakthrough Designation Status for Test for Patients with Suspected Sepsis

Host response diagnostic company, MeMed, announced today the FDA has granted the company a breakthrough device designation (BDD) for its MeMed Severity test. According to the company, the test looks to aid clinicians in rapid risk stratification and predicting disease progression, in conjunction with clinical assessments and other laboratory findings.¹

The test is based on a host-response technology that measures multiple proteins from a blood sample and applies machine learning to stratify the risk that a patient with an acute infection is likely to deteriorate to severe outcomes within 72 hours, or risk of mortality within 14 days. MeMed believes this can be utilized in hospital emergency departments, as it can help in decision-making related to triage, and treatment. The diagnostic use easy-to-interpret results in under 15 minutes, compatibility with high-throughput analyzers and minimal blood volume requirements.¹

“The FDA’s BDD for MeMed Severity validates our commitment to addressing critical healthcare challenges with novel host-response technologies,” MeMed CEO Eran Eden, PhD, said in a statement. “This milestone highlights FDA’s confidence in MeMed’s rigorous development process and the test’s ability to fill a critical gap in sepsis management, equipping clinicians with valuable insights to improve care and save lives."¹

Sepsis can be difficult to diagnose, especially as there is not a singular test for the medical emergency. It can be difficult to determine if the body will be set off by an infection and cause the body’s immune system to overreact, which can lead to a whole host of cascading issues including organ dysfunction, septic shock, multi-organ failure, and possibly death.   

And the medical condition is a frequent event in hospitals. The Centers for Disease Control and Prevention (CDC) estimates that sepsis affects at least 1.7 million Americans annually, with at least 350,000 adults who develop sepsis in the hospital either dying or transitioning to hospice care.² In addition, sepsis also contributes to incident disability where patients who survive sepsis are at increased risk for the development of new morbidity, inability to return to work, hospital readmission, and possibly mortality.²

Trying to Reduce the Burden of Sepsis

The CDC has been involved in addressing sepsis. Last year, the federal agency published its Hospital Sepsis Program Core Elements guideline. It provides hospitals with existing sepsis programs an assessment tool by which to identify and understand shortcomings in their programs. It also has information to start a program.³

A recent survey shows that more hospitals have sepsis committees at their institutions. Specifically, the National Healthcare Safety Network annual survey conducted in 2023 showed that 78% of hospitals have a sepsis committee, which is up 5% from the previous year’s findings.⁴

In a previous interview with Contagion, Raymund Dantes, MD, MPH, Medical Advisor - NHSN, CDC offered some insights into these developments. “From January to March 2024, we asked over 5,000 US hospitals about their sepsis program practices for all of 2023, so this data represents practices both before and after the launch of our Sepsis Core Elements in late August of 2023.”⁴

References

1. FDA Grants Breakthrough Device Designation to MeMed Severity Test for Patients with Suspected Sepsis. MeMed press release. December 10, 2024. Accessed December 10, 2024. https://www.me-med.com/press_release/fda-grants-breakthrough-device-designation-to-memed-severity-test-for-patients-with-suspected-sepsis/
2. Hospital Sepsis Program Core Elements. CDC. August 13, 2024. Accessed December 10, 2024. https://www.cdc.gov/sepsis/hcp/core-elements/index.html
3. LaRosa S.CDC Presents Core Elements for Sepsis Programs. Contagion. September 11, 2023. Accessed December 10, 2024. https://www.contagionlive.com/view/cdc-presents-core-elements-for-sepsis-programs
4. Abene S. New Data Shows Advances In Sepsis Care Across US Hospitals. Contagion. August 30, 2024. Accessed December 10, 2024. https://www.contagionlive.com/view/new-data-from-the-cdc-shows-advances-in-sepsis-care-across-us-hospitals