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QuidelOrtho's (QDEL) New Approval to Aid Pre-eclampsia Diagnosis
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QuidelOrtho Corporation (QDEL - Free Report) recently 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 (a consequence of abnormal placentation and poor blood flow in the placenta), which may lead to maternal and fetal complications of pregnancy, including pre-eclampsia.
It should be noted that the Triage PLGF test is a fluorescence immunoassay to be used with the small-footprint Triage MeterPro Instrument for the quantitative determination of PLGF in maternal plasma specimens.
The latest regulatory approval is likely to significantly boost QuidelOrtho’s Point of Care business.
Significance of the Approval
Per QuidelOrtho’s estimates, pre-eclampsia, a serious disorder, currently affects up to 5% of pregnancies in Canada. The Triage PLGF test can be used with other clinical information to aid in the diagnosis of preterm pre-eclampsia. It also helps in the prognosis of short-term delivery in women with signs and symptoms of pre-eclampsia after 20 weeks and prior to 35 weeks of gestation. Diagnosis of pre-eclampsia indicates delivery within 14 days.
Per management, following the presence of signs or symptoms of pre-eclampsia, the availability of necessary information is crucial for the health and safety of both the mother and the unborn baby. The information will help clinicians determine the optimal course of action to achieve the best possible outcome for the pregnancy. Management believes that the Triage PLGF test will likely aid clinicians in diagnosing pre-eclampsia sooner and provide them with information on whether the pregnancy is likely to deteriorate within the next 14 days. This is expected to enable a better patient care management plan.
Industry Prospects
Per a report by Transparency Market Research, the global pre-eclampsia diagnostics market was valued at $1.5 billion in 2021 and is anticipated to reach $2.3 billion by 2031 at a CAGR of approximately 3.8%. Factors like the increasing incidence of pre-eclampsia and the growing prevalence of lifestyle diseases 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 Development
Last month, QuidelOrtho reported its fourth-quarter 2023 results, wherein it recorded a solid uptick in its Non-respiratory revenues both on a reported and constant currency basis.
Price Performance
Shares of the company have lost 49.9% in the past year against the industry’s 9.3% rise and the S&P 500’s 25.7% growth.
Image Source: Zacks Investment Research
Zacks Rank & Stocks to Consider
Currently, QuidelOrtho carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Cardinal Health, Inc. (CAH - Free Report) and Cencora, Inc. (COR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 12.1%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 35.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 66.3% compared with the industry’s 21.4% rise in the past year.
Cardinal Health, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 14.2%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average being 15.6%.
Cardinal Health has gained 52.3% compared with the industry’s 14.5% rise in the past year.
Cencora, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 9.8%. COR’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 6.7%.
Cencora’s shares have rallied 54.5% compared with the industry’s 2.7% rise in the past year.
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QuidelOrtho's (QDEL) New Approval to Aid Pre-eclampsia Diagnosis
QuidelOrtho Corporation (QDEL - Free Report) recently 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 (a consequence of abnormal placentation and poor blood flow in the placenta), which may lead to maternal and fetal complications of pregnancy, including pre-eclampsia.
It should be noted that the Triage PLGF test is a fluorescence immunoassay to be used with the small-footprint Triage MeterPro Instrument for the quantitative determination of PLGF in maternal plasma specimens.
The latest regulatory approval is likely to significantly boost QuidelOrtho’s Point of Care business.
Significance of the Approval
Per QuidelOrtho’s estimates, pre-eclampsia, a serious disorder, currently affects up to 5% of pregnancies in Canada. The Triage PLGF test can be used with other clinical information to aid in the diagnosis of preterm pre-eclampsia. It also helps in the prognosis of short-term delivery in women with signs and symptoms of pre-eclampsia after 20 weeks and prior to 35 weeks of gestation. Diagnosis of pre-eclampsia indicates delivery within 14 days.
Per management, following the presence of signs or symptoms of pre-eclampsia, the availability of necessary information is crucial for the health and safety of both the mother and the unborn baby. The information will help clinicians determine the optimal course of action to achieve the best possible outcome for the pregnancy. Management believes that the Triage PLGF test will likely aid clinicians in diagnosing pre-eclampsia sooner and provide them with information on whether the pregnancy is likely to deteriorate within the next 14 days. This is expected to enable a better patient care management plan.
Industry Prospects
Per a report by Transparency Market Research, the global pre-eclampsia diagnostics market was valued at $1.5 billion in 2021 and is anticipated to reach $2.3 billion by 2031 at a CAGR of approximately 3.8%. Factors like the increasing incidence of pre-eclampsia and the growing prevalence of lifestyle diseases 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 Development
Last month, QuidelOrtho reported its fourth-quarter 2023 results, wherein it recorded a solid uptick in its Non-respiratory revenues both on a reported and constant currency basis.
Price Performance
Shares of the company have lost 49.9% in the past year against the industry’s 9.3% rise and the S&P 500’s 25.7% growth.
Image Source: Zacks Investment Research
Zacks Rank & Stocks to Consider
Currently, QuidelOrtho carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Cardinal Health, Inc. (CAH - Free Report) and Cencora, Inc. (COR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 12.1%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 35.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 66.3% compared with the industry’s 21.4% rise in the past year.
Cardinal Health, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 14.2%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average being 15.6%.
Cardinal Health has gained 52.3% compared with the industry’s 14.5% rise in the past year.
Cencora, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 9.8%. COR’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 6.7%.
Cencora’s shares have rallied 54.5% compared with the industry’s 2.7% rise in the past year.