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Mugglehead Investment Magazine
Alternative investment news based in Vancouver, B.C.
QuidelOrtho seeks FDA approval to complete acquisition of LEX Diagnostics
QuidelOrtho seeks FDA approval to complete acquisition of LEX Diagnostics
Image from Accuray via Unsplash.

Medical and Pharmaceutical

QuidelOrtho seeks FDA approval to complete acquisition of LEX Diagnostics

LEX Diagnostics develops molecular diagnostics to improve patient care by delivering clinical insights

QuidelOrtho Corporation (NASDAQ: QDEL) intends to acquire complete ownership of LEX Diagnostics after clearance from the U.S. Food and Drug Administration for USD$100 million. It also plans to discontinue developing the company’s Savanna platform.

Announced on Friday, this deal is part of QuidelOrtho’s new refocused molecular diagnostic strategy.

In December 2023, QuidelOrtho invested in LEX Diagnostics and secured an exclusive option to acquire the company. The option extends through the 510(k) clearance process and shortly afterward. LEX Diagnostics plans to submit dual 510(k) and CLIA waiver applications to the FDA in the coming days.

As a result, the company anticipates receiving 510(k) clearance in late 2025 or early 2026. However, the final timing depends on the FDA’s review process.

LEX Diagnostics develops molecular diagnostics aimed at improving patient care by delivering rapid clinical insights when they are most needed. Its proprietary thermal cycling technology enables high sensitivity and exceptional speed without sacrificing quality.

Notably, the company’s ultra fast molecular platform can deliver positive results in about six minutes using a single multiplex test that detects and differentiates Flu A, Flu B, and COVID-19. Meanwhile, negative results are available in approximately 10 minutes.

Furthermore, the LEX Diagnostics system integrates easily into point-of-care workflows. It brings PCR level sensitivity to urgent care centers, physician office labs, hospitals, and other decentralized settings, while maintaining a competitive price point.

“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.

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LEX Diagnostics offers key performance advantages

Blaser said the team compared recent clinical trial results, investment needs, and market potential for both the Savanna and LEX Diagnostics platforms. Based on that analysis, they concluded that LEX Diagnostics delivers key performance advantages for customers and aligns more closely with the company’s strengths and growth opportunities.

QuidelOrtho Corporation develops diagnostic testing solutions that help clinicians make faster, more informed decisions. Further, the company serves global markets across infectious disease, cardiometabolic health, and clinical chemistry. It also offers products for laboratories, hospitals, and point of care settings. QuidelOrtho focuses on delivering high quality diagnostics that improve patient outcomes and streamline clinical workflows.

Recently, the company inked a deal with LEX Diagnostics to expand its point of care capabilities, which led to the acquisition. LEX Diagnostics develops ultra fast molecular diagnostics that provide results within minutes. Its technology delivers positive results for Flu A, Flu B, and COVID 19 in as little as six minutes. Negative results take about ten minutes.

In addition, LEX Diagnostics’ platform integrates easily into decentralized settings such as urgent care centers and physician office labs. It combines PCR level sensitivity with affordability and speed. As a result, the partnership strengthens QuidelOrtho’s position in the growing market for rapid, high performance diagnostics.

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