Indianapolis-based Roche Diagnostics said while the survey was conducted in Europe, its implications are global and reflect challenges in the United States.
The test—developed in collaboration with Eli Lilly and Co.—does not diagnose Alzheimer’s but is designed to rule out the presence of the disease’s pathology early on, or indicate further diagnostics are needed.
The new vitamin D test, to be distributed from the Swiss-based company’s Indianapolis hub, is the first such test using a mass spectrometry-based system to receive regulatory approval in the U.S.
The Swiss pharmaceutical and diagnostics giant said the move will establish the Indianapolis-based Roche Diagnostics site as a hub for manufacturing of its continuous glucose monitoring system.
Roche said Indiana would receive a new manufacturing facility for continuous glucose monitoring and expansion and upgrades at existing pharmaceutical, diagnostics and distribution operations.
The test, one of the first of its kind, is designed to reach patients who may forgo traditional screening because of lack of access, past trauma or embarrassment.
Lipoprotein(a) has long been recognized as a critical marker for people at risk of cardiovascular disease. However, the health care industry has lacked the tools to tackle the problem.
Roche is developing the tests in partnership with Indianapolis-based Eli Lilly and Co. Earlier this year, the U.S. Food and Drug Administration granted a breakthrough device designation to the product.
The Roche drug is a once-daily pill, compared to Lilly’s tirzepatide, sold under the brand names Mounjaro (for diabetes) and Zepbound (for obesity), which is a once-weekly shot.
The company, Carmot Therapeutics, has numerous drugs under development. Its lead asset is a once-a-week injection that is in mid-stage development for the treatment of obesity.
Roche has come under pressure to improve its pipeline with medicines it can commercialize soon as a windfall of revenue from products used in the COVID-19 pandemic comes to an end.
History: Roche Diagnostics Corp. is a division of Roche, the world’s largest biotech company and a global pioneer in pharmaceuticals and diagnostics. The Indianapolis division began as locally based Bio-Dynamics, in 1964. It produced the first device that could test blood-glucose levels without requiring that blood be sent to a laboratory. Amsterdam-based Boehringer Mannheim Corp. […]
Gantenerumab’s demise is a boost for Indianapolis-based Eli Lilly and Biogen, which are also developing treatments for Alzheimer’s, said Tim Anderson, an analyst at Wolfe Research. Lilly shares were up 1.8% at midday.
Brigitte Fernandes is suing Roche for sex discrimination and national origin discrimination. A Roche spokesman declined to comment, citing pending litigation.
Matt Sause, president and CEO of Roche Diagnostics North America since 2019, has been named CEO of Roche Diagnostics and a member of the corporate executive committee. He will relocate to the parent company’s offices in Basel, Switzerland.
