QuidelOrtho Announces Strategy to Accelerate Growth in Molecular Diagnostics
―Company Intends to Acquire LEX Diagnostics Upon U.S. FDA Clearance―
―Company Plans to Discontinue Savanna® Platform Development―
―Company Reaffirms Full Year 2025 Financial Guidance ―
―Company to Host Conference Call Today at 5:00 p.m. ET―
SAN DIEGO, June 3, 2025 /PRNewswire/ -- QuidelOrtho Corporation (NASDAQ:QDEL) (the "Company" or "QuidelOrtho"), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs, and transfusion medicine, today announced a refocusing of its molecular diagnostics strategy. This strategy includes the intent 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 $100 million and plans to discontinue the Company's Savanna platform development.
In December 2023, QuidelOrtho 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.
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.1 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.
"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," Blaser added.
Update on Savanna
QuidelOrtho 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.
Update on 2025 Financial Guidance
Based on its current business outlook, the Company is maintaining its fiscal 2025 financial guidance provided on February 12, 2025. Please see page 6 of the "First Quarter 2025 Financial Results" presentation on the "Investor Relations" section of the Company's website for the full list of assumptions on which the Company's 2025 financial guidance is based.
Conference Call Information
QuidelOrtho will hold a conference call beginning at 2:00 p.m. PT / 5:00 p.m. ET to discuss this announcement. Interested parties can access the call on the "Events & Presentations" section of the "Investor Relations" page of the Company's website at https://ir.quidelortho.com. Presentation materials will also be posted to the "Events & Presentations" section of the Investor Relations page of the Company's website at the time of the call. Those unable to access the webcast may join the call via phone by dialing 833-470-1428 (domestic) or +1 929-526-1599 (international) and entering Conference ID number 732082.
A replay of the conference call will be available shortly after the event on the "Investor Relations" page of the Company's website under the "Events & Presentations" section.
QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.
About QuidelOrtho Corporation
QuidelOrtho Corporation (NASDAQ:QDEL) is a world leader in in vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day.
Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic.
Building upon its many years of groundbreaking innovation, QuidelOrtho continues to partner with customers across the healthcare continuum and around the globe to forge a new diagnostic frontier. One where insights and solutions know no bounds, expertise seamlessly connects and a more informed path is illuminated for each of us.
About LEX Diagnostics
LEX Diagnostics, founded in 2020 as a subsidiary of TTP Group Limited, is a molecular diagnostics company transforming point-of-care testing through its proprietary ultra-fast thermal cycling technology. LEX Diagnostics is headquartered in Cambridgeshire, United Kingdom. Learn more at www.lexdiagnostics.com.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly historical, including, but not limited to, QuidelOrtho's intent to acquire LEX Diagnostics, molecular diagnostic and other strategic goals, financial guidance and related assumptions and other future financial condition and operating results, including expected results of operations or financial position, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words "may," "will," "could," "would," "should," "might," "expect," "anticipate," "believe," "estimate," "plan," "intend," "goal," "project," "strategy," "future," "continue," "aim," "strive," "seek," or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of QuidelOrtho's management as of the date of this press release and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. The following factors, among others, could cause actual results or outcomes to differ from those set forth or implied in the forward-looking statements: failure to complete the proposed acquisition of LEX Diagnostics on the anticipated timeline, or at all, including risks and uncertainties related to LEX Diagnostics securing FDA clearance and satisfying other customary provisions to consummate the proposed acquisition; inability to realize the anticipated benefits of acquisitions or discontinuances of certain business operations; fluctuations in demand for QuidelOrtho's non-respiratory and respiratory products; supply chain, production, logistics, distribution and labor disruptions and challenges; the challenges and costs of integrating, restructuring and achieving anticipated synergies as a result of the business combination of Quidel Corporation and Ortho Clinical Diagnostics Holdings plc or other acquisitions; delays in the development of or failures or delays in the receipt of approvals for future or enhanced products; and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally, including those arising from the effects of announced or future or amended tariffs, trade policies and global trade relations, as well as others discussed in QuidelOrtho's Annual Report on Form 10-K for the fiscal year ended December 29, 2024 and subsequent reports filed with the Securities and Exchange Commission, including under Part I, Item 1A, "Risk Factors" of the Form 10-K. You should not rely on forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date of this press release. QuidelOrtho undertakes no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.
1 This LEX Diagnostics product is currently under development and has not been cleared or approved by the FDA or any other regulatory authority. It is not available for sale or distribution in the U.S. or any other jurisdiction. All product descriptions, data, or discussions are preliminary, subject to change, and do not represent final or FDA-approved claims, indications, or labeling.
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SOURCE QuidelOrtho Corporation