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Quest Diagnostics' (DGX) AAV Test Gets FDA's Breakthrough Nod
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Quest Diagnostics (DGX - Free Report) recently received the FDA’s Breakthrough Device Designation for its Adeno-associated virus, AAVrh74 ELISA assay (CDx). The company also announced an expanded collaboration with Sarepta Therapeutics, Inc (SRPT - Free Report) , under which Quest will develop essential diagnostic tools for Sarepta’s approved gene therapies that help streamline or match gene therapy treatment to eligible patients.
With these recent developments, Quest Diagnostics is spearheading the companion diagnostics innovation in the growing field of gene therapies.
News in Detail
The Breakthrough Device Designation is granted by the FDA to expedite the development and review of certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Image Source: Zacks Investment Research
The enzyme-linked immunosorbent in vitro diagnostic assay is meant for the semi-quantitative detection of antibodies (IgG) to AAVrh74 capsid in human serum. The test is presumed to be used in conjunction with other available clinical information to help identify patients eligible for treatment with SRPT’s ELEVIDYS (delandistrogene moxeparvovec-rokl) — the first and only FDA-approved gene therapy intended to treat the underlying genetic cause of Duchenne muscular dystrophy (DMD).
Significance of the Collaboration
As part of the enhanced collaboration, DGX will develop one or more companion or complementary diagnostics in connection with Sarepta's portfolio of investigational and on-market gene therapies. The partnership may encompass screening assays for antibodies to Sarepta's AAV vector-based gene therapies for muscular dystrophies, including DMD and limb girdle muscular dystrophies. In addition, Quest will provide clinical lab testing for Sarepta.
Per Quest Diagnostics’ representative, the company’s AAV testing expertise has the potential to empower many life science collaborators to develop and ultimately bring companion diagnostics for their gene therapies to the market.
Industry Prospects
Per a Research report, the global AAV vector manufacturing market was valued at $767.7 million in 2022 and is expected to witness a CAGR of 22.5% by 2030.
Strong Potential in Advanced Diagnostics
The highly specialized Advanced Diagnostics services are one of the key areas for Quest Diagnostics to support faster growth across all its customer segments. The services include molecular genomics and oncology tests, such as germline testing to assess prenatal and hereditary genetic risks and somatic testing for tumor sequencing. Neurology, women's reproductive health and cardiometabolic health are other important areas of this segment.
Quest’s AD-Detect portfolio of Alzheimer's blood tests firmly positions the company to lead in the rapidly evolving Alzheimer's landscape. Currently available to physicians across the United States, the test equally holds the potential to gather strong customer demand. In addition, Quest’s cardiometabolic, endocrinology, infectious disease and carrier and prenatal genetic screening services continue to be widely accepted.
Price Performance
In the past six months, Shares of DGX have decreased 5.4% against the industry’s rise of 1.8%.
Zacks Rank and Key Picks
Quest Diagnostics currently carries a Zacks Rank #3 (Hold).
Shares of HealthEquity have risen 2.7% in the past year. Earnings estimates for HQY have remained constant at $1.92 for 2023 and have moved up from $2.47 to $2.48 for 2024 in the past 30 days.
HealthEquity’s earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 9.10%. In the last reported quarter, it posted an earnings surprise of 21.95%.
Estimates for Quanterix’s 2023 loss per share have narrowed from $1.16 to 97 cents in the past 30 days. Shares of the company have increased 191.5% in the past year compared with the industry’s rise of 0.2%.
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
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Quest Diagnostics' (DGX) AAV Test Gets FDA's Breakthrough Nod
Quest Diagnostics (DGX - Free Report) recently received the FDA’s Breakthrough Device Designation for its Adeno-associated virus, AAVrh74 ELISA assay (CDx). The company also announced an expanded collaboration with Sarepta Therapeutics, Inc (SRPT - Free Report) , under which Quest will develop essential diagnostic tools for Sarepta’s approved gene therapies that help streamline or match gene therapy treatment to eligible patients.
With these recent developments, Quest Diagnostics is spearheading the companion diagnostics innovation in the growing field of gene therapies.
News in Detail
The Breakthrough Device Designation is granted by the FDA to expedite the development and review of certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Image Source: Zacks Investment Research
The enzyme-linked immunosorbent in vitro diagnostic assay is meant for the semi-quantitative detection of antibodies (IgG) to AAVrh74 capsid in human serum. The test is presumed to be used in conjunction with other available clinical information to help identify patients eligible for treatment with SRPT’s ELEVIDYS (delandistrogene moxeparvovec-rokl) — the first and only FDA-approved gene therapy intended to treat the underlying genetic cause of Duchenne muscular dystrophy (DMD).
Significance of the Collaboration
As part of the enhanced collaboration, DGX will develop one or more companion or complementary diagnostics in connection with Sarepta's portfolio of investigational and on-market gene therapies. The partnership may encompass screening assays for antibodies to Sarepta's AAV vector-based gene therapies for muscular dystrophies, including DMD and limb girdle muscular dystrophies. In addition, Quest will provide clinical lab testing for Sarepta.
Per Quest Diagnostics’ representative, the company’s AAV testing expertise has the potential to empower many life science collaborators to develop and ultimately bring companion diagnostics for their gene therapies to the market.
Industry Prospects
Per a Research report, the global AAV vector manufacturing market was valued at $767.7 million in 2022 and is expected to witness a CAGR of 22.5% by 2030.
Strong Potential in Advanced Diagnostics
The highly specialized Advanced Diagnostics services are one of the key areas for Quest Diagnostics to support faster growth across all its customer segments. The services include molecular genomics and oncology tests, such as germline testing to assess prenatal and hereditary genetic risks and somatic testing for tumor sequencing. Neurology, women's reproductive health and cardiometabolic health are other important areas of this segment.
Quest’s AD-Detect portfolio of Alzheimer's blood tests firmly positions the company to lead in the rapidly evolving Alzheimer's landscape. Currently available to physicians across the United States, the test equally holds the potential to gather strong customer demand. In addition, Quest’s cardiometabolic, endocrinology, infectious disease and carrier and prenatal genetic screening services continue to be widely accepted.
Price Performance
In the past six months, Shares of DGX have decreased 5.4% against the industry’s rise of 1.8%.
Zacks Rank and Key Picks
Quest Diagnostics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are HealthEquity (HQY - Free Report) and Quanterix (QTRX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Shares of HealthEquity have risen 2.7% in the past year. Earnings estimates for HQY have remained constant at $1.92 for 2023 and have moved up from $2.47 to $2.48 for 2024 in the past 30 days.
HealthEquity’s earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 9.10%. In the last reported quarter, it posted an earnings surprise of 21.95%.
Estimates for Quanterix’s 2023 loss per share have narrowed from $1.16 to 97 cents in the past 30 days. Shares of the company have increased 191.5% in the past year compared with the industry’s rise of 0.2%.
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.