Revvity Announces Program to Revolutionize the Early Detection of Type 1 Diabetes
Initiative spans an IVD assay and a new Revvity Omics lab-developed test to expand clinical testing for early-stage disease screening
Revvity, Inc. (NYSE:RVTY) today announced a program for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Sanofi (NASDAQ:SNY). Revvity will develop a T1D 4-plex in vitro diagnostic (IVD) assay based on its existing research-use (RUO) 3-plex assay.
T1D is a lifelong, progressive autoimmune condition that occurs when the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Early detection of T1D enables options for patients and caregivers to improve outcomes through intervention to prevent the natural progression of the disease and complications such as diabetic ketoacidosis (DKA). Over 9 million people worldwide live with T1D with more than 500,000 new cases diagnosed each year—90% without a family history.
The collaboration supports clinical validation and regulatory submissions of the new T1D 4-plex assay on Revvity's GSP® instrument using capillary dried blood spot (DBS) and venous specimens. The GSP® instrument's high throughput capability enables population-level screening for early-stage T1D in clinical practice, an important advance in the evolution of the standard of care. Regulatory submissions are planned for the U.S. FDA, IVDR and other major jurisdictions.
"The expansion of autoantibody testing from research-use towards convenient, affordable, high-quality and high-throughput commercial platforms such as Revvity GSP may accelerate the transition to a new clinical standard of care where people with T1D are diagnosed as early as possible," said Shirley Gil Parrado, global head of autoimmune type 1 diabetes at Sanofi.
In parallel, Revvity and Sanofi are also collaborating to expand access to Revvity's existing RUO product. Currently offered as an LDT at the CLIA and CAP accredited Revvity Omics laboratory in Pittsburgh, PA, Revvity will work to validate the assay in additional locations across its global laboratory network to facilitate worldwide access to the assay for clinical use.
"Revvity Omics has built a reputation as a global leader in genomic testing for both rare and common conditions—pushing the boundaries of technology across multiple platforms. Today's announcement is a pivotal step forward, showing that we're not just capable but eager to further expand into non-rare diseases," said Dr. Madhuri Hegde, senior vice president and chief scientific officer at Revvity. "This collaboration reinforces the value of collaboration across biotech, improving patient outcomes by ensuring assays are available to identify the people who would benefit from therapeutics developed by the pharmaceutical industry."
Factors Affecting Future Performance
This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes", "intends", "anticipates", "plans", "expects", "estimates", "projects", "forecasts", "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management's current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) fluctuations in the global economic and political environments, including as the result of recently implemented and recently threatened tariff increases; (3) our failure to introduce new products in a timely manner; (4) our ability to execute acquisitions and divestitures, license technologies, or to successfully integrate acquired businesses or licensed technologies into our existing businesses or to make them profitable; (5) our ability to compete effectively; (6) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (7) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (8) disruptions in the supply of raw materials and supplies; (9) our ability to retain key personnel; (10) significant disruption in our information technology systems, or cybercrime; (11) our ability to realize the full value of our intangible assets; (12) our failure to adequately protect our intellectual property; (13) the loss of any of our licenses or licensed rights; (14) the manufacture and sale of products exposing us to product liability claims; (15) our failure to maintain compliance with applicable government regulations; (16) our failure to comply with data privacy and information security laws and regulations; (17) regulatory changes; (18) our failure to comply with healthcare industry regulations; (19) economic, political and other risks associated with foreign operations; (20) our ability to obtain future financing; (21) restrictions in our credit agreements; (22) significant fluctuations in our stock price; (23) reduction or elimination of dividends on our common stock; and (24) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
About Revvity
At Revvity, "impossible" is inspiration, and "can't be done" is a call to action. Revvity provides health science solutions, technologies, expertise, and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what's possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.
With 2024 revenue of more than $2.7 billion and approximately 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 160 countries.
Stay updated by following our Newsroom, LinkedIn, X, YouTube, Facebook and Instagram.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251002034718/en/
Investor Relations:
Steve Willoughby
[email protected]
Media Relations:
Chet Murray
(781) 462-5126
[email protected]
