Home 5 Lab Industry Advisor 5 Essential 5 MeMed Sepsis Test Gains Breakthrough Device Designation

MeMed Sepsis Test Gains Breakthrough Device Designation

by | Jan 31, 2025 | Essential, FDA-lca, Lab Industry Advisor

The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to a new test from Israeli firm MeMed that can diagnose a suspected case of sepsis within minutes.1

Sepsis is the body’s severe inflammatory reaction to an infection. This inflammation can lead to clots in blood vessels, hampering blood flow to the body’s internal organs. If left untreated, it can lead to septic shock, organ failure, and death.2

Sepsis can be treated with antibiotics, anti-inflammatory medications, and fluid if diagnosed quickly, but it still has a roughly 15 percent mortality rate. The mortality rate for cases that progress into septic shock can be 50 percent or higher.3 Sepsis is one of the leading causes of death globally.4

The challenges of diagnosing sepsis

However, diagnosis has always been a challenge, as patients with sepsis often show symptoms that could indicate a variety of other illnesses. Hospitals must closely monitor vital signs for any dramatic changes that may indicate the presence of sepsis, such as a drop in blood pressure.

“Managing patients with suspected sepsis is a race against time, where fast and accurate risk assessment is essential,” said Beat Müller, MD, a physician and professor at the University of Basel in Switzerland, in a statement. “Conventional tools of clinical routine, even in top-class hospital centers, often lack predictive accuracy, contributing to alert fatigue while missing subtle, life-threatening cases.”1

Advantages of the MeMed test

The MeMed Severity test is an offshoot of the company’s MeMed BV® test, which the FDA granted 510(k) approval back in July 2023.5 That assay can determine whether a patient is suffering from a viral or bacterial infection, both of which have starkly different courses of treatment. 

According to MeMed, the Severity assay measures multiple proteins from a blood sample and can stratify the risks to a patient of developing sepsis from their infection. The company claims it can predict “severe outcomes” from infections, including the risk of death over the next 14 days. Tests can be conducted on the MeMed BV platform—which is about the size of a toaster oven—and can be performed in less than 15 minutes.1 A MeMed spokesperson adds that only 0.1 milliliters of blood collected in a common EDTA collection tube is required to perform the assay. The test may be performed separately from the MeMed BV assay.

Full FDA approval expected in 2026

There have not yet been any formally published peer review studies on the test’s effectiveness in diagnosing and treating sepsis. However, MeMed has been performing product validation studies on about 3,000 patients. The first studies are expected to be published within the next several months, according to MeMed vice president of product and marketing Tal Avziz.

With the Breakthrough Device Designation, MeMed Severity is on a fast track for full FDA approval. Avziz says the company expects that approval to come by 2026.

“We are grateful for the FDA’s commitment to collaborate with MeMed during its rigorous development process to create a test capable of filling a critical gap in sepsis management, equipping clinicians with valuable insights to improve care and save lives,” said MeMed chief executive officer Eran Eden in the statement announcing Breakthrough Device status for the test.1

The potential retail price for the test remains confidential. “We are committed to making this test affordable to ensure broad reach for patients everywhere,” Avziz says.

ADLM changes position on DTC testing

In other recent diagnostics news, the Association for Diagnostics and Laboratory Medicine (ADLM) has made a significant change to its position on direct-to-consumer (DTC) testing, responding to a market that has been flooded with such products in recent years.

The new position—posted by ADLM late last year—likely reflects a boom in the DTC testing business.6 A recent report from Nova One Advisor predicts the DTC testing market will grow from less than $4 billion in 2023 to more than $7 billion by the end of this decade and nearly $9.3 billion by 2033.7

Concerns around DTC tests

Firms such as 23andMe have become well-known in the public sphere through their offerings of DTC genetic tests for individuals.

However, the scientific community has at times scoffed at the rapid growth of DTC testing. A recent editorial by the British medical journal The Lancet concluded that much of the growth has been driven by fear—which may be further compounded by the tests themselves.8

“Fear about what lies in our future is fundamental to being human, so the rise of direct-to-consumer genetic testing is no surprise,” The Lancet wrote. “However, tests for genetic risk of diseases such as cancer…often report on only a small fraction of known pathogenic variants—for example, in BRCA genes. Such tests can provide false reassurance to those testing negative. Conversely, the psychological effects of receiving a positive test result can be enormous.”8

DTC regulation

The FDA does not regulate all DTC tests. According to the agency, “in general, direct-to-consumer tests for non-medical, general wellness, or low-risk medical purposes are not reviewed by the FDA before they are offered. Direct-to-consumer tests for moderate to high-risk medical purposes, which may have a higher impact on medical care, are generally reviewed by the FDA to determine the validity of test claims.”9

A middle ground on DTC tests

The ADLM’s new position appears to be striking a middle ground between the fact such tests appear to be here to stay, while also noting that consumers are entitled to reliable and accurate information from such assays.

The association seems far less skeptical about DTC testing than its prior stance, which included numerous caveats for consumers regarding the cost of tests and their general reliability and clinical utility.10

In its new statement, ADLM is essentially embracing DTC tests, and although it still acknowledges the risks they present, the association notes that these risks have been muted compared to when it released its past position.

“To mitigate potential harm, it is essential that labs performing consumer directed testing explain the purpose of each test in an accessible and easily understandable way,” the ADLM states in its new position. “Labs should also detail when it’s appropriate to use the test, potential risks, and associated costs. Results should be presented in an easy-to-understand manner and options for further professional medical advice should be available.”6

The position also stated that the Centers for Medicare & Medicaid Services should regulate all labs that perform DTC testing.

References:

    1. https://www.businesswire.com/news/home/20241210254875/en/FDA-Grants-Breakthrough-Device-Designation-to-MeMed-Severity-Test-for-Patients-with-Suspected-Sepsis

    1. https://my.clevelandclinic.org/health/diseases/12361-sepsis

    1. https://pmc.ncbi.nlm.nih.gov/articles/PMC4641283/

    1. https://www.who.int/news-room/fact-sheets/detail/sepsis

    1. https://www.me-med.com/press_release/fda-clears-memed-bv-direct-from-whole-blood/

    1. https://myadlm.org/advocacy-and-outreach/position-statements/2024/direct-to-consumer-laboratory-testing

    1. https://www.biospace.com/direct-to-consumer-laboratory-testing-market-size-to-hit-usd-9-27-bn-by-2033

    1. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01924-X/fulltext

    1. https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests

    1. https://myadlm.org/advocacy-and-outreach/position-statements/2019/direct-to-consumer-laboratory-testing

Subscribe to view Essential

Start a Free Trial for immediate access to this article