QuidelOrtho Corporation QDEL recently announced the FDA 510(k) clearance for its VITROS syphilis assay as part of its menu, which is likely to strengthen its position as a leader in infectious disease testing.
The expansion into the U.S. market aims to provide timely and accurate diagnosis, crucial for effective treatment and control of the disease. With this latest development, QDEL’s shares are likely to witness a northward movement.
More on QDEL’s VITROS Syphilis Assay
The VITROS syphilis assay is designed to qualitatively determine total (IgG and IgM) antibodies to antigens specific to Treponema pallidum (TP) in human serum and plasma using automated VITROS 3600, 5600, and XT 7600 systems. The diagnosis of syphilis infection may be aided by the presence of antibodies to TP-specific antigens, non-treponemal laboratory testing, and clinical symptoms.
Screening for blood and tissue donors is not intended to be performed with the VITROS syphilis assay. The VITROS syphilis assay is now accessible everywhere QuidelOrtho products are sold, including the United States.
This important assay not only improves laboratory efficiency by allowing labs to follow the CDC’s reverse testing algorithm for syphilis screening, but it also reduces costs by providing earlier disease detection, thereby reducing the need to refer tests to outside labs.
More on QDEL’s Robust Product Portfolio
QuidelOrtho’s diagnostic testing solutions include the Sofia and Sofia 2 Analyzers, QuickVue, and InflammaDry and AdenoPlus products.
Per management, Savanna is continuing to provide significant competitive advantages in the Molecular Point-of-Care market. A successful U.S. launch of QDEL’s Savanna instrument is likely to offer incremental revenue and margin growth opportunities for the company. Building on the Savanna instrument and HSV panel approvals in the United States, the company expects to enter clinical trials on its respiratory panel later this year. The company aims to be in the market with both the Respiratory Panel and the STI panel in 2025.
In April 2024, QuidelOrtho announced the addition of the ARK Fentanyl II Assay to its U.S. Vitros XT 7600 and 5600 Integrated Systems, as well as its Vitros 4600 Chemistry System menu of assays as a MicroTip Partnership Assay.
QuidelOrtho also announced the FDA 510(k) clearance for its QuickVue COVID-19 test. With CLIA certificates of waiver, this approval permits the test to be used accurately and conveniently in home and medical healthcare settings.
In March 2024, the company announced the receipt of Health Canada’s approval for its Triage PLGF (placental growth factor) test for laboratory use in Canada. The test is intended to detect the presence of angiogenic imbalance, which may lead to maternal and fetal complications of pregnancy, including pre-eclampsia.
QDEL’s Price Performance
In the past six months, QDEL’s shares have lost 4.3% against the industry’s rise of 5.3%. The S&P 500 has gained 9.2% in the same time frame.
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QDEL’s Zacks Rank & Stocks to Consider
QDEL carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the broader medical space are Universal Health Service UHS, Quest Diagnostics DGX and ABM Industries ABM. While Universal Health Service sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Universal Health Service has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.
Universal Health Service has gained 41.1% compared with the industry's 34.8% rise so far this year.
Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.
Quest Diagnostics shares have gained 3.7% so far this year compared with the industry’s 10.2% rise.
ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.
ABM's shares have risen 24.1% so far this year compared with the industry’s 11.9% growth.
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