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Labcorp's (LH) At-Home Mpox Testing Kit Gets the FDA's EUA Nod

Laboratory Corporation of America Holdings LH, or Labcorp, recently received the FDA’s Emergency Use Authorization (“EUA”) for its Mpox PCR Test Home Collection Kit. This is the first at-home collection kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox.

Labcorp’s new collection kit is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection. The development reflects the company’s ongoing dedication to providing critical diagnostic tools to physicians and accessible and convenient testing options to patients.

More on Labcorp’s New Collection Kit

The new Mpox PCR Test Home Collection Kit includes detailed instructions for patients on correctly collecting a lesion swab, securing the sample in the provided collection tube and preparing the package for return to an authorized laboratory for analysis. Physicians can order a test through Labcorp's provider interface platform for patients they suspect may be infected with the virus, and the company will send the test kit directly to patients for at-home collection.

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Testing of specimens collected using the test kit will employ PCR (polymerase chain reaction) technology and will be conducted in authorized laboratories designated by Labcorp and certified under the Clinical Laboratory Improvement Amendments of 1988 to meet the requirements for performing high-complexity testing criteria for the detection of non-variola Orthopoxvirus DNA.

Results are electronically delivered to the prescribing physician and made available to the patient in Labcorp's patient portal at patient.labcorp.com. The company also aims to make the test available on its Labcorp OnDemand platform.

Significance of the Test

Labcorp's chief medical and scientific officer emphasized the importance of the FDA's emergency authorization grant of the Mpox PCR Test Home Collection Kit, stating that it will enable the company to play a vital role within the healthcare community in the early detection and management of mpox. The authorization comes amid reported increases in mpox cases in the United States.

According to the Centers for Disease Control and Prevention (“CDC”), there have been 511 mpox cases reported in 2024 through Mar 16 compared to fewer than 300 cases reported by late March 2023. Since the onset of the national 2022-2023 mpox virus outbreak, part of a larger global outbreak of human mpox caused by the West African clade of the monkeypox virus, the CDC has documented more than 32,000 cases and 58 deaths nationally.

Labcorp’s Mpox PCR Test Home Collection Kit has not yet been cleared or approved by the FDA but has been authorized for emergency use under an EUA. The emergency use is only authorized for the duration of the declaration that justifies the emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including non-variola Orthopoxvirus, and remains in effect unless the declaration is terminated or authorization is revoked sooner. Moreover, the authorization is limited only for the collection and maintenance of lesion swab specimens to help in the detection of nucleic acid from non-variola Orthopoxvirus, including monkeypox virus, and not for any other viruses or pathogens.

Industry Prospects

Per a Research report, the global monkeypox vaccine and treatment market was valued at $85.2 million in 2022 and is expected to witness a CAGR of 10.2% by 2030.

The market growth is fueled by the increasing incidence of monkeypox infection across the globe and the rising demand for treatment and prevention methods. According to the report, government initiatives such as the U.S. Monkeypox Research Priorities to boost R&D and the heightened awareness among people regarding monkeypox are expected to boost growth in the future.

Notable Developments

Last month, Labcorp’s introduction of the pTau217 (phosphorylated tau 217) blood biomarker test represented a significant milestone in the company’s ongoing commitment to advance testing capabilities across the spectrum of Alzheimer's disease. The test can be ordered by physicians and used in clinical trials and research by global biopharmaceutical partners.

In January 2024, the company announced the launch and availability of a new, FDA-cleared blood test for risk assessment and clinical management of severe preeclampsia in pregnant women. Recognized by TIME Magazine as one of the Best Inventions of 2023, the B•R•A•H•M•S sFlt-1/PlGF KRYPTOR test developed by Thermo Fisher Scientific TMO measures two angiogenic biomarkers associated with preeclampsia — serum soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor.

Price Performance

In the past six months, shares of Labcorp have increased 2.5% compared with the industry’s rise of 6.1%.

Zacks Rank and Key Picks

Labcorp currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are DaVita DVA and Cardinal Health CAH. While DaVita sports a Zacks Rank #1 (Strong Buy), Cardinal Health carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

DaVita’s stock has surged 55.7% in the past year. Earnings estimates for DaVita have risen from $8.97 to $9.23 in 2024 and from $9.77 to $10.01 in 2025 in the past 30 days.

DVA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 35.6%. In the last reported quarter, it posted an earnings surprise of 22.2%.

Estimates for Cardinal Health’s 2024 earnings per share have remained constant at $7.28 in the past 30 days. Shares of the company have surged 31.8% in the past year compared with the industry’s 9.7% rise.

CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%. In the last reported quarter, it delivered an average earnings surprise of 16.7%.

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Labcorp (LH) : Free Stock Analysis Report

DaVita Inc. (DVA) : Free Stock Analysis Report

Thermo Fisher Scientific Inc. (TMO) : Free Stock Analysis Report

Cardinal Health, Inc. (CAH) : Free Stock Analysis Report

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