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QuidelOrtho's (QDEL) Latest FDA Nod to Boost Diagnostic Testing
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QuidelOrtho Corporation (QDEL - Free Report) recently announced the receipt of the FDA’s 510(K) clearance for its Savanna PCR (polymerization chain reaction) platform and Savanna HSV 1+2/VZV in vitro diagnostic test. The clearance is 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.
Per QuidelOrtho, the Savanna HSV 1+2/VZV test panel is intended to aid in the differential diagnosis of infections with these viruses. Management had aimed to make Savanna available to professional customers on Dec 20, 2023.
The latest regulatory approval is likely to significantly boost QuidelOrtho’s Molecular Diagnostics business unit across the United States.
Significance of the Approval
The receipt of the FDA’s clearance will allow 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. Per the company, as Savanna will likely deliver results in a few minutes, this will likely improve clinical care, provide cost savings and deliver sample-to-result molecular testing across all laboratory settings.
Per management, the Savanna platform, with its powerful set of features, is expected to make it a suitable tool for syndromic testing in hospitals and moderate-complexity labs. Management also aims to eventually access physician offices, urgent care clinics and other point-of-care locations.
Industry Prospects
Per a report by Precedence Research, the global diagnostic testing market was valued at $165.58 billion in 2021 and is anticipated to exceed $348.75 billion by 2030 at a CAGR of approximately 8.6%. Factors like the increasing use of point-of-care diagnostic products, growing focus on preventive care and the rising elderly population leading to an increase in the chance of developing a wide range of illnesses (including diabetes) are likely to drive the market.
Given the market potential, the latest regulatory clearance will likely provide a significant impetus to QuidelOrtho’s business.
Notable Developments
Last month, QuidelOrtho reported its third-quarter 2023 results, wherein it registered an uptick in its Non-Respiratory revenues. It also recorded robust revenues from its Labs and Transfusion Medicine segments and China and Other regions. QuidelOrtho also witnessed strong revenue growth in the Europe, the Middle East and Africa region on a reported basis. Solid revenues from its Instrument and Recurring revenue categories were also seen. The continued uptick in Sofia instruments and growth in QuidelOrtho’s integrated installed base and automation were encouraging.
In September, QuidelOrtho announced that it had been granted a CLIA Waiver by the FDA, which applied to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay).
Price Performance
Shares of the company have lost 17.9% in the past year compared with the industry’s 2.4% decline. The S&P 500 has witnessed 23.7% growth in the said time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, QuidelOrtho carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , HealthEquity, Inc. (HQY - Free Report) and Integer Holdings Corporation (ITGR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 17.3%. DVA’s earnings surpassed estimates in all the trailing four quarters, with an average surprise of 36.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 41.5% compared with the industry’s 7.6% rise in the past year.
HealthEquity, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 27.5%. HQY’s earnings surpassed estimates in all the trailing four quarters, with an average of 16.5%.
HealthEquity has gained 6.1% against the industry’s 8.8% decline over the past year.
Integer Holdings, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 11.9%.
Integer Holdings’ shares have rallied 43.9% compared with the industry’s 1.9% rise in the past year.
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QuidelOrtho's (QDEL) Latest FDA Nod to Boost Diagnostic Testing
QuidelOrtho Corporation (QDEL - Free Report) recently announced the receipt of the FDA’s 510(K) clearance for its Savanna PCR (polymerization chain reaction) platform and Savanna HSV 1+2/VZV in vitro diagnostic test. The clearance is 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.
Per QuidelOrtho, the Savanna HSV 1+2/VZV test panel is intended to aid in the differential diagnosis of infections with these viruses. Management had aimed to make Savanna available to professional customers on Dec 20, 2023.
The latest regulatory approval is likely to significantly boost QuidelOrtho’s Molecular Diagnostics business unit across the United States.
Significance of the Approval
The receipt of the FDA’s clearance will allow 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. Per the company, as Savanna will likely deliver results in a few minutes, this will likely improve clinical care, provide cost savings and deliver sample-to-result molecular testing across all laboratory settings.
Per management, the Savanna platform, with its powerful set of features, is expected to make it a suitable tool for syndromic testing in hospitals and moderate-complexity labs. Management also aims to eventually access physician offices, urgent care clinics and other point-of-care locations.
Industry Prospects
Per a report by Precedence Research, the global diagnostic testing market was valued at $165.58 billion in 2021 and is anticipated to exceed $348.75 billion by 2030 at a CAGR of approximately 8.6%. Factors like the increasing use of point-of-care diagnostic products, growing focus on preventive care and the rising elderly population leading to an increase in the chance of developing a wide range of illnesses (including diabetes) are likely to drive the market.
Given the market potential, the latest regulatory clearance will likely provide a significant impetus to QuidelOrtho’s business.
Notable Developments
Last month, QuidelOrtho reported its third-quarter 2023 results, wherein it registered an uptick in its Non-Respiratory revenues. It also recorded robust revenues from its Labs and Transfusion Medicine segments and China and Other regions. QuidelOrtho also witnessed strong revenue growth in the Europe, the Middle East and Africa region on a reported basis. Solid revenues from its Instrument and Recurring revenue categories were also seen. The continued uptick in Sofia instruments and growth in QuidelOrtho’s integrated installed base and automation were encouraging.
In September, QuidelOrtho announced that it had been granted a CLIA Waiver by the FDA, which applied to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay).
Price Performance
Shares of the company have lost 17.9% in the past year compared with the industry’s 2.4% decline. The S&P 500 has witnessed 23.7% growth in the said time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, QuidelOrtho carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , HealthEquity, Inc. (HQY - Free Report) and Integer Holdings Corporation (ITGR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 17.3%. DVA’s earnings surpassed estimates in all the trailing four quarters, with an average surprise of 36.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 41.5% compared with the industry’s 7.6% rise in the past year.
HealthEquity, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 27.5%. HQY’s earnings surpassed estimates in all the trailing four quarters, with an average of 16.5%.
HealthEquity has gained 6.1% against the industry’s 8.8% decline over the past year.
Integer Holdings, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 11.9%.
Integer Holdings’ shares have rallied 43.9% compared with the industry’s 1.9% rise in the past year.