Thermo Fisher Scientific, Inc. TMO recently announced the receipt of the FDA Emergency Use Authorization (EUA) for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit. The kit is a polymerase chain reaction (PCR) test intended to spot non-variola Orthopoxviruses, including the monkeypox virus, in nearly three-and-a-half hours.
The recent approval is expected to bolster Thermo Fisher’s Specialty Diagnostics segment.
More on the News
The TaqPath Monkeypox/Orthopox Virus DNA Kit is intended to qualitatively detect DNA from the monkeypox virus (clade I/II) and screen non-variola Orthopoxviruses in human lesion swab specimens from individuals suspected of monkeypox (mpox) infection by their healthcare provider.
The positive results suggest the presence of DNA from the monkeypox virus or other non-variola Orthopoxvirus. Clinicians must associate PCR results with patient history and other diagnostic information to determine infection status.
Significance of the Test Kit
It is to be noted that, in early 2020, Thermo Fisher was among the first companies to distribute an emergency-use authorized assay to recognize active SARS-CoV-2 infections with the TaqPath COVID-19 Combo Kit. The TaqPath Monkeypox/Orthopox Virus DNA Kit imitates Thermo Fisher’s continued commitment to building diagnostic tools intended to tackle pressing public health emergencies.
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Per management, ensuring that all laboratories in the United States have access to monkeypox PCR testing is vital to responding to the public health emergency. The approval of the testing kit will help expedite the availability of results so that patients can get suitable treatment quickly. Authorized testing also allows public health agencies to track viral spread and address affected populations accordingly.
Industry Prospects
Per a report by Precedence Research, the global genetic testing market was estimated at $8 billion in 2021 and is expected to surpass $15.8 billion by 2030 at a CAGR of 7.6%. The rising prevalence of chronic and genetic diseases and the introduction of innovative testing kits owing to technological advancements are the factors driving the market.
Recent Developments
In December 2022, Thermo Fisher launched the TrueMark Infectious Disease Research Panels intended to allow rapid and accurate detection and categorization for investigating microorganisms that cause respiratory, vaginal, urinary, gastrointestinal, and sexually transmitted diseases. By utilizing real-time PCR technology, the assays can detect over 90 different disease pathogens.
In the same month, Thermo Fisher received FDA approval itsSeCore CDx HLA Sequencing System was granted De Novo Classification. The SeCore CDx HLA Sequencing System is the first HLA typing test to receive marketing authorization from the FDA for use as a companion diagnostic
Price Performance
Shares of the company have lost 18.9% in a year compared with the industry’s fall of 29.9%.
Zacks Rank and Key Picks
Currently, Thermo Fisher carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space that investors can consider are ShockWave Medical, Inc. SWAV, Orthofix Medical Inc. OFIX and Merit Medical System MMSI.
ShockWave Medical, sporting a Zacks Rank #2 (Buy) 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 35% against the industry’s 32.6% fall in the past year.
Orthofix Medical, currently carrying a Zacks Rank #1 (Strong Buy), reported third-quarter 2022 adjusted EPS of 13 cents, which beat the Zacks Consensus Estimate by a stupendous 550%. Revenues of $114 million outpaced the consensus mark by 2.7%.
Orthofix Medical has an estimated next-year growth rate of 58.97%. MMSI’s earnings surpassed estimates in the trailing three quarters and missed in one, the average being 129.1%. You can see the complete list of today’s Zacks #1 Rank stocks here.
Merit Medical, currently carrying a Zacks Rank of 2, reported third-quarter 2022 adjusted EPS of 64 cents, which beat the Zacks Consensus Estimate by 20.8%. Revenues of $287.2 million outpaced the consensus mark by 5.2%.
Merit Medical has an estimated long-term growth rate of 11%. MMSI’s earnings surpassed estimates in all the trailing four quarters, the average being 25.4%.
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