Dawson James Securities initiated coverage of Bluejay Diagnostics (NASDAQ:BJDX) with a “buy” rating and price target of $10. The stock closed at $2.74 on Jan. 11.
Bluejay is focused on improving patient outcomes in the critical care setting using the company’s Symphony diagnostic platform. The goal is to deliver a rapid, cost-efficient, point of care product for IL-6, a key inflammation marker, in diseases like Sepsis and Covid.
“In doing so, we see Symphony as driving a paradigm shift,” writes analyst Jason Kolbert.
Bluejay initiated the start of the clinical testing program for the IL-6 test for sepsis triage in October 2021 under a single protocol at three sites, two in the University of Texas Southwestern Medical Center and the third site at the Parkland Memorial Hospital.
Results from this program should form the basis of an FDA pre-submission application expected to be filed early this year, Mr. Kolbert said. The results from this program form the basis of the company’s planned 510(k) marketing application, expected in the third quarter of 2022, he added.
Mr. Kolbert said the company plans to incorporate feedback from the FDA pre-submission to modify these studies to support premarket clearance, which could be through a traditional 510(k) or de novo application.
The company also may consider alternative regulatory paths, including, for example, an emergency use authorization, he added.