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Revvity, Inc. RVTY announced the receipt of the FDA’s 510(k) clearance for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. Per management, it is currently the only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma.
The results on EUROIMMUN’s ChLIA platforms are expected to be rapidly available, with the first result available under an hour (in 48 minutes). It also has an estimated throughput of nearly 60 tests per hour.
The latest regulatory clearance is a significant stepping stone for Revvity to advance its diagnostic capabilities for androgen disorders.
Likely Trend of RVTY Stock Following the News
Following the announcement, shares of the company lost nearly 2.2% till Friday’s closing.
Historically, the company has gained a top-line boost from its various regulatory achievements and product launches. Although the latest FDA approval is likely to be beneficial for RVTY’s top-line growth going forward, the stock declined overall.
Revvity currently has a market capitalization of $13.86 billion. It has an earnings yield of 4.4%, favorable than the industry’s 3.7%. In the last reported quarter, RVTY delivered an earnings surprise of 13.3%.
Significance of the FDA Approval for Revvity
Per Revvity, the assay is processed on the company’s random-access iSYS or i10 instruments to deliver quick turnaround times and high-throughput testing. It needs minimal technician training and expertise to handle while maintaining high accuracy and reliability. The assay is expected to provide direct measurement of free testosterone levels in a single test, enhancing diagnostic capabilities for conditions such as hypogonadism and impotence, among others.
Management believes that the regulatory clearance will likely expand the FDA-cleared menu for the EUROIMMUN family of ChLIA automation solutions with assays that serves a diverse patient pool across all demographics.
Industry Prospects in Favor of RVTY
Per a report by Future Market Insights, the global testosterone test market recorded a market valuation of $100 million in 2023 and is anticipated to reach $208.1 million by 2034 at a CAGR of 6.9%. Factors like the rising awareness about hormonal disorders and the increasing prevalence of male infertility are likely to drive the market.
Given the market potential, the latest FDA clearance is expected to be a significant milestone for Revvity and boost its business.
Revvity’s Notable Developments
In November 2024, Revvity announced an expansion of its work with Genomics England that leverages both organizations' expertise and resources to advance critical genomic initiatives across the United Kingdom.