FDA Grants Breakthrough Device Designation to MeMed BV Flex Finger-Prick Test

The US Food and Drug Administration has granted breakthrough device designation to MeMed BV Flex, an investigational test meant to distinguish bacterial from viral infections using a few drops of capillary blood, the Israeli diagnostics company announced, MLO reported on March 12.

The designation provides prioritized and more interactive FDA engagement during development and review, Clinical Lab Products reported, citing the company. It is not a marketing authorization. "MeMed BV Flex is an investigational device and has not been approved or cleared for sale by any regulatory authority," the company said.

What the test measures

According to MeMed, the test measures multiple immune proteins and applies machine-learning algorithms to produce a score in 15 minutes. It runs on the company's MeMed Key platform and is intended, pending regulatory clearance, for hospitals as well as CLIA-waived and decentralized care settings, CAP Today reported.

The capillary version builds on MeMed BV, which the FDA has already cleared for venous samples. The 510(k) record for the most recent clearance, K230944, lists MeMed Diagnostics of Tirat Carmel, Israel, as the applicant. The cleared indication describes an automated immunoassay that "measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum and venous whole blood samples" as an aid to differentiate bacterial from viral infection, for patients in the emergency department or urgent care, or at hospital admission, with symptoms for less than seven days.

BV Flex would extend that approach to finger-prick samples. MeMed said the capillary format is designed to expand accessibility, particularly for children and the elderly, according to Clinical Lab Products.

What the company says comes next

MeMed said the designation also makes the test eligible for Medicare's New Technology Add-on Payment alternative pathway and Transitional Coverage for Emerging Technologies, programs that may support broader Medicare coverage and strengthen market access, according to Clinical Lab Products.

"We are grateful for the FDA's Breakthrough Device Designation, which recognizes the strength of our platform technology and helps streamline our path toward clearance, reimbursement, and ultimately advancing the management of patients with fever and sepsis," said Eran Eden, chief executive and co-founder of MeMed, in the release, as quoted by Clinical Lab Products.

The company has an earlier breakthrough device designation for MeMed Severity, a host-response test intended to predict severe outcomes in patients with acute infections and suspected sepsis, which has not yet been cleared for sale in any territory, Clinical Lab Products reported.

MeMed did not give a timeline for submitting BV Flex to the FDA or disclose any clinical study results for the capillary version in the coverage reviewed.