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RVTY Expands Endocrine Diagnostics With FDA-Cleared Testosterone Assay
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Key Takeaways
RVTY's IDS unit received FDA clearance for its Total Testosterone automated ChLIA assay.
Revvity's platform now supports total, free testosterone and SHBG testing on one system.
RVTY says the portfolio may reduce reliance on complex ED-LC/MS testing methods.
Revvity, Inc. (RVTY - Free Report) recently announced that its subsidiary, Immunodiagnostic Systems (“IDS”), received FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA). The assay complements the company’s existing FDA-cleared ChLIA tests for free testosterone and sex hormone-binding globulin (SHBG), creating a comprehensive automated testosterone testing solution on a single platform.
Management stated that the addition of the total testosterone assay transforms the company’s ChLIA platform into a fully integrated solution supporting diagnostic testing for androgen-related conditions in both men and women. The FDA clearance also reflects Revvity’s continued commitment to expanding its reproductive endocrine disorders portfolio and improving the timely diagnosis of endocrine-related conditions.
Likely Trend of RVTY Stock Following the News
Following the announcement, RVTY shares dropped 4.3% at yesterday’s closing. In the year-to-date period, shares of the company lost 1.8% compared with the industry’s 10.3% decline. However, the S&P 500 has risen 8.7% in the same timeframe.
The FDA clearance is expected to strengthen Revvity’s position in the growing endocrine diagnostics and reproductive health testing market. The launch of a fully automated testosterone testing solution on a single platform may increase adoption among clinical laboratories seeking more efficient and scalable diagnostic workflows. Continued portfolio expansion in reproductive and endocrine testing may reinforce Revvity’s competitive position in the broader diagnostics market.
RVTY currently has a market capitalization of $11.10 billion.
Image Source: Zacks Investment Research
More on the News
The expanded testing portfolio supports direct ChLIA measurement of total testosterone, SHBG and free testosterone, supporting both first- and second-line diagnostic testing for suspected hypogonadism in men.
Running on IDS’ random-access automation platforms, the portfolio enables laboratories to perform testing on a single platform while reducing dependence on equilibrium dialysis-liquid chromatography/mass spectrometry (ED-LC/MS) methods, which are often operationally complex and difficult to reproduce. The streamlined approach is expected to improve laboratory efficiency without sacrificing diagnostic accuracy or reliability.
Beyond testosterone testing, Revvity continues to expand its reproductive endocrine disorders portfolio with additional FDA-cleared assays, including 17-OH progesterone (17-OHP), androstenedione and prolactin.
Industry Prospects Favoring the Market
Going by the data provided by Fortune Business Insights, the endocrine testing market is valued at $15.69 billion in 2026 and is expected to witness a CAGR of 8.6% through 2034.
Factors like the rising prevalence of endocrine and metabolic disorders, growing adoption of advanced diagnostic technologies and increasing focus on preventive healthcare and long-term disease monitoring are boosting the market’s growth.
Other News
Recently, Revvity exited the first quarter of 2026 with earnings and revenues surpassing estimates. Top-line performance benefited from growth in Life Sciences, driven by demand in pharma/biotech and academic/government markets, alongside strength in Diagnostics led by reproductive health testing. During the quarter, Revvity continued investing in innovation through the launch of Signals BioDesign software and the Opera Phenix OptiQ high-content screening system, reinforcing its focus on expanding long-term growth opportunities.
Some better-ranked stocks from the broader medical space are West Pharmaceutical (WST - Free Report) , Globus Medical (GMED - Free Report) and Intuitive Surgical (ISRG - Free Report) .
West Pharmaceutical, currently sporting a Zacks Rank #1 (Strong Buy), reported first-quarter 2026 EPS of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 19.4%.
Globus Medical, currently sporting a Zacks Rank #1, reported a first-quarter 2026 adjusted earnings per share (EPS) of $1.12 per share, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
GMED has an estimated long-term earnings growth rate of 10.2%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
Intuitive Surgical, carrying a Zacks Rank #2 (Buy) at present, reported first-quarter 2026 adjusted EPS of $2.50, which beat the Zacks Consensus Estimate by 20.2%. Revenues of $2.77 billion surpassed the Zacks Consensus Estimate by 6.2%.
Intuitive Surgical has a long-term estimated growth rate of 14.6%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.
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RVTY Expands Endocrine Diagnostics With FDA-Cleared Testosterone Assay
Key Takeaways
Revvity, Inc. (RVTY - Free Report) recently announced that its subsidiary, Immunodiagnostic Systems (“IDS”), received FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA). The assay complements the company’s existing FDA-cleared ChLIA tests for free testosterone and sex hormone-binding globulin (SHBG), creating a comprehensive automated testosterone testing solution on a single platform.
Management stated that the addition of the total testosterone assay transforms the company’s ChLIA platform into a fully integrated solution supporting diagnostic testing for androgen-related conditions in both men and women. The FDA clearance also reflects Revvity’s continued commitment to expanding its reproductive endocrine disorders portfolio and improving the timely diagnosis of endocrine-related conditions.
Likely Trend of RVTY Stock Following the News
Following the announcement, RVTY shares dropped 4.3% at yesterday’s closing. In the year-to-date period, shares of the company lost 1.8% compared with the industry’s 10.3% decline. However, the S&P 500 has risen 8.7% in the same timeframe.
The FDA clearance is expected to strengthen Revvity’s position in the growing endocrine diagnostics and reproductive health testing market. The launch of a fully automated testosterone testing solution on a single platform may increase adoption among clinical laboratories seeking more efficient and scalable diagnostic workflows. Continued portfolio expansion in reproductive and endocrine testing may reinforce Revvity’s competitive position in the broader diagnostics market.
RVTY currently has a market capitalization of $11.10 billion.
Image Source: Zacks Investment Research
More on the News
The expanded testing portfolio supports direct ChLIA measurement of total testosterone, SHBG and free testosterone, supporting both first- and second-line diagnostic testing for suspected hypogonadism in men.
Running on IDS’ random-access automation platforms, the portfolio enables laboratories to perform testing on a single platform while reducing dependence on equilibrium dialysis-liquid chromatography/mass spectrometry (ED-LC/MS) methods, which are often operationally complex and difficult to reproduce. The streamlined approach is expected to improve laboratory efficiency without sacrificing diagnostic accuracy or reliability.
Beyond testosterone testing, Revvity continues to expand its reproductive endocrine disorders portfolio with additional FDA-cleared assays, including 17-OH progesterone (17-OHP), androstenedione and prolactin.
Industry Prospects Favoring the Market
Going by the data provided by Fortune Business Insights, the endocrine testing market is valued at $15.69 billion in 2026 and is expected to witness a CAGR of 8.6% through 2034.
Factors like the rising prevalence of endocrine and metabolic disorders, growing adoption of advanced diagnostic technologies and increasing focus on preventive healthcare and long-term disease monitoring are boosting the market’s growth.
Other News
Recently, Revvity exited the first quarter of 2026 with earnings and revenues surpassing estimates. Top-line performance benefited from growth in Life Sciences, driven by demand in pharma/biotech and academic/government markets, alongside strength in Diagnostics led by reproductive health testing. During the quarter, Revvity continued investing in innovation through the launch of Signals BioDesign software and the Opera Phenix OptiQ high-content screening system, reinforcing its focus on expanding long-term growth opportunities.
Revvity Inc. Price
Revvity Inc. price | Revvity Inc. Quote
RVTY’s Zacks Rank & Key Picks
Revvity currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are West Pharmaceutical (WST - Free Report) , Globus Medical (GMED - Free Report) and Intuitive Surgical (ISRG - Free Report) .
West Pharmaceutical, currently sporting a Zacks Rank #1 (Strong Buy), reported first-quarter 2026 EPS of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 19.4%.
Globus Medical, currently sporting a Zacks Rank #1, reported a first-quarter 2026 adjusted earnings per share (EPS) of $1.12 per share, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
GMED has an estimated long-term earnings growth rate of 10.2%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
Intuitive Surgical, carrying a Zacks Rank #2 (Buy) at present, reported first-quarter 2026 adjusted EPS of $2.50, which beat the Zacks Consensus Estimate by 20.2%. Revenues of $2.77 billion surpassed the Zacks Consensus Estimate by 6.2%.
Intuitive Surgical has a long-term estimated growth rate of 14.6%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.