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.
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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.
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About 1 million people are living with multiple sclerosis in the U.S., and about 10% of those have PPMS, making it the least common form of the disease.
She and her husband, Robert, purchased the company in 1997, but she worked her way up the corporate ladder before taking on an official role.
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 threat comes as Trump also pressures drugmakers to lower prices of pharmaceuticals in the United States.
At the 5,000-square-foot Roche Community Garden, Roche employees grow tomatoes, strawberries, watermelons and a variety of peppers to be provided to low-income patients.
The new late-stage study will focus on people who are at risk of cognitive decline.
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.
The the Swiss drugmaker will face off in the obesity area with leaders Novo Nordisk A/S and Indianapolis-based Eli Lilly and Co.
Roche and Lilly said they believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis.
Wong’s appointment comes just a few weeks after BioCrossroads released a report warning that Indiana’s life-science sector is starting to lag the nation in growth and market share and will require a focused effort to stay competitive.
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.
Brad Moore succeeds Matt Sause, who was appointed CEO of Roche Diagnostics globally in October.
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.
In a statement to IBJ, Roche said it hopes to display “supportive and inspiring messages” visible from I-69 as part of a new corporate initiative.
The contract is part of the U.S. government’s effort to double its procurement of rapid COVID-19 tests to be delivered for free to Americans through a forthcoming federal website.
