QuidelOrtho Receives 510(K) Clearance for Savanna® Multiplex Molecular Platform and Savanna® HSV 1+2/VZV PCR Assay
QuidelOrtho Corporation (Nasdaq: QDEL) has received 510(K) clearance from the U.S. Food and Drug Administration for its Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test, allowing them to market and sell the innovative platform to laboratories performing moderate or high complexity diagnostic testing in the United States. The platform delivers results in 25 minutes or less, improves clinical care, provides cost savings, and delivers sample-to-result molecular testing across all laboratory settings.
The recent FDA approval of QuidelOrtho's Savanna PCR platform and its diagnostic test for HSV-1, HSV-2 and VZV represents a significant advancement in the field of in vitro diagnostics . This clearance not only validates the platform's clinical utility but also opens up a new revenue stream for the company in the U.S. market. The ability to deliver results in under 25 minutes is a substantial improvement over existing diagnostic methods, potentially leading to faster clinical decision-making and treatment, which in turn could reduce overall healthcare costs.
From an investment perspective, this regulatory milestone may positively influence QuidelOrtho's stock performance as the market often reacts favorably to such advancements. The expansion of their product portfolio and entry into the point-of-care diagnostic space could lead to increased market share and competitive advantage. However, investors should also consider the costs associated with the production, marketing and distribution of the new platform and tests, as well as the company's ability to scale effectively.
The approval of QuidelOrtho's Savanna platform underlines a growing trend in the healthcare industry towards syndromic testing and point-of-care solutions. The platform's design for use in various healthcare settings, including hospitals and potentially physician offices, aligns with the industry's focus on improving diagnostic efficiency and patient outcomes. The multiplex capability of analyzing up to 12 pathogens positions the Savanna system as a versatile tool in the fight against infectious diseases.
Long-term implications for stakeholders include the potential for QuidelOrtho to capture a larger share of the diagnostics market, particularly in the segment of rapid testing. The strategic significance of the platform's small footprint and integrated sample preparation should not be underestimated, as these features cater to the needs of space-constrained facilities and support the ongoing shift towards decentralized diagnostics.
The FDA's 510(K) clearance of QuidelOrtho's Savanna platform is a pivotal event that may influence the company's financial projections and valuation. The clearance can lead to revenue growth from sales of the new platform and associated test kits. The multiplexing capability and the speed of the Savanna system could result in a competitive edge, potentially increasing the company's market share in the diagnostic sector.
However, investors should monitor the adoption rate of the new platform and the operational execution as the company scales up production. Additionally, the competitive landscape and pricing strategies will be critical factors in determining the long-term financial impact of this product launch. It is essential to analyze the company's quarterly earnings and any guidance provided on the expected financial contribution of the Savanna platform to gain a clearer picture of its economic significance.
12/20/2023 - 04:05 PM
Savanna delivers results in 25 minutes or less, improves clinical care, provides cost savings and delivers sample-to-result molecular testing across all laboratory settings
SAN DIEGO --(BUSINESS WIRE)--
QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”) , a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received 510(K) clearance from the U.S. Food and Drug Administration for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2) and Varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients. The clearance allows QuidelOrtho to market and sell the Savanna multiplex molecular platform and the Savanna HSV 1+2/VZV assay to laboratories performing moderate or high complexity diagnostic testing in the United States .
“Our relentless pursuit of revolutionizing testing across the healthcare continuum has resulted in the achievement of another major milestone – the clearance of our Savanna platform and the Savanna HSV 1+2/VZV assay,” said Douglas Bryant, President and Chief Executive Officer of QuidelOrtho. “We’re truly differentiating diagnostics in the marketplace and allowing labs and healthcare workers to provide the quick diagnoses needed in critical situations.”
The Savanna multiplex molecular platform enables professional customers to analyze up to 12 pathogens or targets, plus up to four controls, from a single test run in roughly 25 minutes, depending on the assay. Savanna is a fully integrated, sample-to-result, automated in vitro diagnostic platform that performs real-time polymerization chain reaction (“PCR”) tests by using the Savanna instrument and Savanna assay cartridges. After inserting the customizable test panel cartridge, the instrument performs sample and reagent preparation, nucleic acid extraction and amplification, real-time detection of RNA or DNA target sequence, and qualitative or quantitative result interpretation from a variety of sample types. The Savanna platform is intended to aid in the diagnosis of related diseases, ensuring patients get the right diagnosis quickly and accurately.
“The Savanna platform’s small footprint hides a powerful set of features, such as integrated sample prep combined with rapid real-time PCR amplification and detection technologies, making it a perfect fit for syndromic testing in hospitals and moderate-complexity labs, with the goal of eventually accessing physician offices, urgent care clinics and other point-of-care locations. Savanna is a truly compelling product, our next flagship platform and an important growth driver,” said Bryant.
The Savanna HSV 1+2/VZV test panel is intended to aid in the differential diagnosis of infections with these viruses. Savanna will be available to professional customers on December 20, 2023.
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. So that patients, clinicians and health officials can spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence.
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.
QuidelOrtho is advancing diagnostics to power a healthier future.
For more information, please visit www.quidelortho.com .
Source: QuidelOrtho Corporation
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Source: QuidelOrtho Corporation
What is the 510(K) clearance received by QuidelOrtho Corporation for?
QuidelOrtho Corporation (Nasdaq: QDEL) has received 510(K) clearance from the U.S. Food and Drug Administration for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2) and Varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients.
What are the features of the Savanna multiplex molecular platform?
The Savanna multiplex molecular platform enables professional customers to analyze up to 12 pathogens or targets, plus up to four controls, from a single test run in roughly 25 minutes, depending on the assay. It is a fully integrated, sample-to-result, automated in vitro diagnostic platform that performs real-time polymerization chain reaction (PCR) tests.
When will the Savanna platform be available to professional customers?
Savanna will be available to professional customers on December 20, 2023.
