We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

QuidelOrtho

Develops, manufactures and markets rapid diagnostic tests that focus on infectious diseases, reproductive health, and... read more Featured Products: More products

Download Mobile App




QuidelOrtho to Acquire MDx Company LEX Diagnostics

By LabMedica International staff writers
Posted on 04 Jun 2025

QuidelOrtho Corporation (San Diego, CA, USA) has announced a refocusing of its molecular diagnostics strategy which now includes acquiring LEX Diagnostics (Cambridgeshire, UK) and discontinuing development of the company's Savanna platform. More...

QuidelOrtho intends to acquire full ownership of LEX Diagnostics after 510(k) clearance by the U.S. Food and Drug Administration (FDA) for consideration at closing of approximately USD 100 million. LEX Diagnostics is a molecular diagnostics company developing products designed to enhance patient care by delivering clinical insights within minutes and at the time they are most valuable. LEX Diagnostics' thermal cycling technology is designed to combine exceptional speed with high sensitivity, without compromising quality. LEX Diagnostics' ultra-fast molecular platform can report positive results in approximately six minutes with a single multiplex test for the detection and differentiation of Flu A, Flu B and COVID-19, while negative results can be reported in approximately 10 minutes. The LEX Diagnostics system integrates into point-of-care workflows, bringing the sensitivity of PCR to urgent care centers, physician office labs, hospitals and other decentralized settings at a competitive price.

In December 2023, QuidelOrtho, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, invested in LEX Diagnostics, which included the exclusive option to acquire the company up to or shortly after 510(k) clearance by the FDA. LEX Diagnostics expects to submit dual 510(k) and CLIA-waiver applications to the FDA in the coming days and expects to receive 510(k) clearance in late 2025 or early 2026, depending on FDA review timelines. QuidelOrtho also plans to discontinue its Savanna platform development. This decision reflects several factors, including the recent results of the Savanna RVP4X clinical trial. The company intends to work closely with its customers and partners to facilitate an orderly transition plan.

"Since joining QuidelOrtho one year ago, we have been engaged in a comprehensive, continuous review of our strategy to drive shareholder value. This afternoon we announced a significant step to realign our product portfolio to drive future growth. Our intended acquisition of LEX Diagnostics will strengthen and accelerate our presence in point-of-care molecular diagnostics—one of the largest and fastest-growing segments in the diagnostics industry," said Brian J. Blaser, President and Chief Executive Officer, QuidelOrtho. "In comparing the results of recent clinical trial data, investment requirements, and the significant market opportunity for both the Savanna and LEX Diagnostics platforms, we determined that LEX Diagnostics offers important performance advantages for customers and is better aligned with our strengths and opportunities for growth."

Related Links:
QuidelOrtho Corporation
LEX Diagnostics 


New
Gold Member
Quality Control Material
iPLEX Pro Exome QC Panel
POC Helicobacter Pylori Test Kit
Hepy Urease Test
New
8-Channel Pipette
SAPPHIRE 20–300 µL
New
Laboratory Software
ArtelWare
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Immunology

view channel
Image: The test could streamline clinical decision-making by identifying ideal candidates for immunotherapy upfront (Xiao, Y. et al. Cancer Biology & Medicine July 2025, 20250038)

Blood Test Predicts Immunotherapy Efficacy in Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is an aggressive subtype lacking targeted therapies, making immunotherapy a promising yet unpredictable option. Current biomarkers such as PD-L1 expression or tumor... Read more

Microbiology

view channel
Image: New diagnostics could predict a woman’s risk of a common sexually transmitted infection (Photo courtesy of 123RF)

New Markers Could Predict Risk of Severe Chlamydia Infection

Chlamydia trachomatis is a common sexually transmitted infection that can cause pelvic inflammatory disease, infertility, and other reproductive complications when it spreads to the upper genital tract.... Read more

Technology

view channel
Image: The sensor can help diagnose diabetes and prediabetes on-site in a few minutes using just a breath sample (Photo courtesy of Larry Cheng/Penn State)

Graphene-Based Sensor Uses Breath Sample to Identify Diabetes and Prediabetes in Minutes

About 37 million U.S. adults live with diabetes, and one in five is unaware of their condition. Diagnosing diabetes often requires blood draws or lab visits, which are costly and inconvenient.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.