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Quest Diagnostics (DGX) Stock Gains on EUA for Monkeypox Test
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Quest Diagnostics (DGX - Free Report) recently received FDA’s emergency use authorization (EUA) for its proprietary monkeypox test. This came on the heels of the Department of Health and Human Services’ declaration (on Sep 7) to allow the FDA Commissioner issue an EUA for in-vitro diagnostics to expand the availability of tests for monkeypox.
Following this, the FDA issued a new guidance, outlining the agency’s current view regarding enforcement policies, recommendations for EUA requests for monkeypox diagnostic tests and its plans to prioritize the review of EUA requests.
Simultaneously, the FDA issued the first EUA for a monkeypox in-vitro diagnostic. This Monkeypox Virus Qualitative Real-Time PCR of Quest Diagnostics is intended to detect monkeypox and other non-variola orthopoxvirus DNA using lesion swab specimens.
The FDA stated that Quest Diagnostics had submitted data demonstrating that its test for distribution to other laboratories met the standards for the issuance of an EUA.
Shares of Quest Diagnostics rose 1.7% to $127.45 at yesterday’s close.
More About the Test
Quest Diagnostics’ test is a lab-developed molecular diagnostic test.
This novel dual-target test is based on polymerase chain reaction (PCR) to aid in the qualitative detection of non-variola orthopoxviruses and monkeypox virus (West African clade) DNA, using swab specimens from patients with an acute pustular or vesicular rash.
Image Source: Zacks Investment Research
According to the company, this test can differentiate monkeypox viral DNA from other non-variola orthopoxviruses in a specimen, allowing a faster final diagnosis.
Strategic Implication
This, being the first lab-developed test to get an EUA specifically for monkeypox virus DNA detection, should get huge market acceptance amid the ongoing public health emergency. With the EUA, Quest Diagnostics believes that it is well positioned to complement the response of public health laboratories and help fight the spread of the virus.
Focus on Testing Expansion
Quest Diagnostics continues to ramp up investments in advanced diagnostics capabilities. In the second quarter, the company saw robust performances in hematology, prenatal genetics and pharma services. The company introduced Quest AD-Detect, a blood test, to help in the early determination of Alzheimer’s disease.
In Q2, Quest Diagnostics delivered growth in direct-to-consumer testing, banking on its COVID-19 offerings and base business testing. The base business testing category saw robust growth from testosterone, comprehensive metabolic panels and Lyme disease in the second quarter.
Share Price Performance
In the past year, Quest Diagnostics has outperformed its industry. The stock has lost 19.4% compared with a 37.6% decline of the industry.
Zacks Rank & Key Picks
Quest Diagnostics currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. (AMN - Free Report) , ShockWave Medical, Inc. and McKesson Corporation (MCK - Free Report) .
AMN Healthcare has a long-term earnings growth rate of 3.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.7%, on average. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
AMN Healthcare has outperformed its industry in the past year. AMN has lost 17.4% compared with the industry’s 30.7% fall.
ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. The company’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.
ShockWave Medical has outperformed its industry in the past year. SWAV has gained 63.8% against the industry’s 32.3% fall over the past year.
McKesson has an estimated long-term growth rate of 9.9%. The company surpassed earnings estimates in the trailing three quarters and missed in one, delivering a surprise of 13%, on average. It currently carries a Zacks Rank #2 (Buy).
McKesson has outperformed its industry in the past year. MCK has gained 46.4% against the industry’s 13.3% fall.
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Quest Diagnostics (DGX) Stock Gains on EUA for Monkeypox Test
Quest Diagnostics (DGX - Free Report) recently received FDA’s emergency use authorization (EUA) for its proprietary monkeypox test. This came on the heels of the Department of Health and Human Services’ declaration (on Sep 7) to allow the FDA Commissioner issue an EUA for in-vitro diagnostics to expand the availability of tests for monkeypox.
Following this, the FDA issued a new guidance, outlining the agency’s current view regarding enforcement policies, recommendations for EUA requests for monkeypox diagnostic tests and its plans to prioritize the review of EUA requests.
Simultaneously, the FDA issued the first EUA for a monkeypox in-vitro diagnostic. This Monkeypox Virus Qualitative Real-Time PCR of Quest Diagnostics is intended to detect monkeypox and other non-variola orthopoxvirus DNA using lesion swab specimens.
The FDA stated that Quest Diagnostics had submitted data demonstrating that its test for distribution to other laboratories met the standards for the issuance of an EUA.
Shares of Quest Diagnostics rose 1.7% to $127.45 at yesterday’s close.
More About the Test
Quest Diagnostics’ test is a lab-developed molecular diagnostic test.
This novel dual-target test is based on polymerase chain reaction (PCR) to aid in the qualitative detection of non-variola orthopoxviruses and monkeypox virus (West African clade) DNA, using swab specimens from patients with an acute pustular or vesicular rash.
Image Source: Zacks Investment Research
According to the company, this test can differentiate monkeypox viral DNA from other non-variola orthopoxviruses in a specimen, allowing a faster final diagnosis.
Strategic Implication
This, being the first lab-developed test to get an EUA specifically for monkeypox virus DNA detection, should get huge market acceptance amid the ongoing public health emergency. With the EUA, Quest Diagnostics believes that it is well positioned to complement the response of public health laboratories and help fight the spread of the virus.
Focus on Testing Expansion
Quest Diagnostics continues to ramp up investments in advanced diagnostics capabilities. In the second quarter, the company saw robust performances in hematology, prenatal genetics and pharma services. The company introduced Quest AD-Detect, a blood test, to help in the early determination of Alzheimer’s disease.
In Q2, Quest Diagnostics delivered growth in direct-to-consumer testing, banking on its COVID-19 offerings and base business testing. The base business testing category saw robust growth from testosterone, comprehensive metabolic panels and Lyme disease in the second quarter.
Share Price Performance
In the past year, Quest Diagnostics has outperformed its industry. The stock has lost 19.4% compared with a 37.6% decline of the industry.
Zacks Rank & Key Picks
Quest Diagnostics currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. (AMN - Free Report) , ShockWave Medical, Inc. and McKesson Corporation (MCK - Free Report) .
AMN Healthcare has a long-term earnings growth rate of 3.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.7%, on average. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
AMN Healthcare has outperformed its industry in the past year. AMN has lost 17.4% compared with the industry’s 30.7% fall.
ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. The company’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.
ShockWave Medical has outperformed its industry in the past year. SWAV has gained 63.8% against the industry’s 32.3% fall over the past year.
McKesson has an estimated long-term growth rate of 9.9%. The company surpassed earnings estimates in the trailing three quarters and missed in one, delivering a surprise of 13%, on average. It currently carries a Zacks Rank #2 (Buy).
McKesson has outperformed its industry in the past year. MCK has gained 46.4% against the industry’s 13.3% fall.