LEX Diagnostics | Submission for FDA 510(k) Clearance

‘The Scius team provided valuable counsel and support in announcing our submission for FDA 510(k) clearance for our innovative LEX VELO diagnostic system and the news that we had received an offer to acquire the technology for $100million subject to approval. The coverage secured significantly raised awareness of this important milestone and our potential acquisition, significantly enhancing our visibility within the industry.’

Ed Farrell
CEO of LEX Diagnostics

Objectives

Announce LEX Diagnostics’ submission of dual applications for FDA 510(k) clearance and CLIA waiver for its innovative LEX VELO System.
Position Lex Diagnostics as a leader in diagnostic testing & highlight the innovative capabilities of the LEX VELO System.
Raise awareness & drive interest in the company’s advances in rapid diagnostics.
Use the ‘regulatory’ release to highlight the exciting news that the company has had a takeover bid.

Strategy

Edited press release & wrote media Q&A, and detailed pitch covering this news and pushing the takeover news.
Created a bespoke media pitch list and targeted trade journalists, successfully securing interviews.
Distributed press materials via GDPR-compliant platforms Roxhill and GlobeNewswire.
Created LinkedIn post including visual.
Coordinated the upload of the announcement to the LEX Diagnostics website for maximum exposure.

Results

Secured extensive coverage in leading trade and local news publications, including: BioWorld Medtech, Business Weekly, Cambridge Independent, GenomeWeb / 360 Dx, Today’s Clinical Lab.
Significant visibility for the company’s VELO System and its capabilities within the diagnostics industry.
Strong engagement from key industry stakeholders, including media, investors, and potential partners.