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RVTY Stock Falls Despite FDA Nod for Automated Testosterone Test
RVTYRevvity(RVTY) ZACKS·2025-01-13 15:55

Company Overview - Revvity has a market capitalization of $13.86 billion with an earnings yield of 4.4%, which is favorable compared to the industry's 3.7% [1] - The company delivered an earnings surprise of 13.3% in the last reported quarter [1] FDA Approval and Product Development - Revvity received FDA 510(k) clearance for EUROIMMUN's automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone, making it the only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma [2] - The assay is processed on Revvity's random-access iSYS or i10 instruments, offering quick turnaround times, high-throughput testing, minimal technician training, and high accuracy [4] - The assay is expected to enhance diagnostic capabilities for conditions like hypogonadism and impotence by providing direct measurement of free testosterone levels in a single test [4] - Management believes the FDA clearance will expand the FDA-cleared menu for EUROIMMUN's ChLIA automation solutions, serving a diverse patient pool across all demographics [5] - Results on EUROIMMUN's ChLIA platforms are expected to be rapidly available, with the first result available in 48 minutes and an estimated throughput of nearly 60 tests per hour [15] Market and Industry Prospects - The global testosterone test market was valued at $100 million in 2023 and is anticipated to reach $208.1 million by 2034, growing at a CAGR of 6.9% [6] - Factors driving the market include rising awareness about hormonal disorders and increasing prevalence of male infertility [6] - The latest FDA clearance is expected to be a significant milestone for Revvity, boosting its business in this growing market [6] Recent Developments - In November 2024, Revvity expanded its collaboration with Genomics England to advance critical genomic initiatives across the UK [7] - The company reported solid revenue growth in its third-quarter 2024 results, both on a reported and organic basis [7] Stock Performance - Following the FDA approval announcement, Revvity's shares lost nearly 2.2% by Friday's closing [3] - Historically, the company has gained a top-line boost from regulatory achievements and product launches, but the stock declined overall despite the latest FDA approval [3] - Over the past year, Revvity's shares have gained 2.8%, outperforming the industry's 9.8% decline, while the S&P 500 gained 23% [9] Comparison with Industry Peers - Cardinal Health (CAH) has a Zacks Rank 2 (Buy) with an estimated long-term growth rate of 10.5% and an average earnings surprise of 11.2% over the trailing four quarters [11] - ResMed (RMD) has a Zacks Rank 2 with an estimated long-term growth rate of 14.8% and an average earnings surprise of 6.4% over the trailing four quarters [12] - Boston Scientific (BSX) has a Zacks Rank 2 with an estimated long-term growth rate of 13.8% and an average earnings surprise of 8.3% over the trailing four quarters [12] - Cardinal Health's shares have gained 14.9% compared to the industry's 2.1% growth, ResMed has gained 34.5% compared to the industry's 7.8% growth, and Boston Scientific has rallied 58.3% compared to the industry's 7.8% growth over the past year [11][12][13]