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LabCorp (LH) Gets FDA's EUA for Combined Home Collection Kit

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Laboratory Corporation of America Holdings or LabCorp (LH - Free Report) gained the FDA’s Emergency Use Authorization (EUA) for a combined home collection kit that can simultaneously detect COVID-19 and influenza A/B in individuals aged two years and above.

The kit will be given at no upfront cost to individuals who meet the clinical guidelines, such as experiencing symptoms, being exposed to someone infected with COVID-19 or those being asked to be tested by a healthcare provider.

The new combined collection kit allows people to test for both flu and COVID-19 in the safety of their homes, avoiding the risk of spreading the virus to others. Per management, the single test will assist doctors and individuals to make more informed treatment decisions during the flu season since the symptoms of COVID-19 and flu are similar.

The recent EUA from the FDA will expand LabCorp’s suite of readily accessible prevention-to-detection solutions for COVID-19. Since March 2020, the company has completed more than 50 million COVID-19 PCR tests and can process up to 300,000 of the same tests per day.

Quick Results With Combined Collection Kit

The above-mentioned kit can be requested online through the Pixel by LabCorp by adults aged 18 years and older as well as parents and guardians of children in the 2-17 year age-group, beginning early October. Physicians can also order the collection kit directly from their electronic medical record system for children as young as two-year olds.

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The combined collection kit comes with a prepaid return envelope and is shipped through FedEx Priority Overnight. The test results are available within one to two days, on average, post the receipt of the completed collection kit by LabCorp. Results are often available within a day of receiving the kit and are accessible via an individual’s Pixel by LabCorp account.

More About the Combined Collection Kit

The combined collection kit utilizes the Roche cobas SARS-CoV-2 & influenza A/B Test for use on the cobas 6800/8800 Systems. By utilizing the high-volume cobas 6800/8800 Systems, this PCR test simultaneously detects and differentiates SARS-CoV-2, influenza A and B, allowing labs to offer reliable, consolidated and accurate results. The cobas SARS-CoV-2 & influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay, which includes a full-process negative control, positive control and internal control.

Negative results do not rule out infection from SARS-CoV-2 or influenza virus. Negative results should be combined with clinical observations, patient history and epidemiological information rather than being used as the sole basis of treatment or other patient management decisions.

Industry Prospects

Per a report published in Grand View Research, the global COVID-19 diagnostics market size is expected to see a CAGR of 3.1% from 2021 to 2027. Factors driving the market include increasing government initiatives to implement mass testing, growing demand for COVID-19 diagnostic products owing to a spike in coronavirus-infected patients, new entrants shifting their focus to at-home testing and several testing programs aiding the travel industry.

Given the market prospects, the recent EUA for LabCorp’s combined home collection kit intended for simultaneous COVID-19 and flu detection seems well-timed.

Notable Developments

In September 2021, LabCorp completed the acquisition of Myriad Genetics’ (MYGN - Free Report) autoimmune business unit’s select operating assets and intellectual property ("IP") including the Vectra rheumatoid arthritis ("RA") assay. The company entered into a definitive agreement, earlier this year, to acquire Myriad’s Vectra test, related IP and other RA assets. The transaction’s particular details, however, were kept under wraps.

In August 2021, the company announced the acquisition of Ovia Health, a digital health platform utilized by women seeking information and support regarding family planning, pregnancy and parenting. The transaction strengthens LabCorp’s position as a leading, go-to source for women’s health insights, expands opportunities for personalized care experiences, and facilitates better communication between health care providers and patients.

Share Price Performance

The stock has outperformed its industry over the past year. It has rallied 44.8% compared with the industry’s growth of 26.8%.

Zacks Rank and Key Picks

Currently, LabCorp carries a Zacks Rank #3 (Hold). Two better-ranked stocks from the Medical-Dental Supplies industry are Henry Schein, Inc. (HSIC - Free Report) and Patterson Companies, Inc. (PDCO - Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Henry Schein has a long-term earnings growth rate of 13.9%.

Patterson Companies has a long-term earnings growth rate of 9.6%.