Iris International Seeks Reimbursement For Its Prostate Molecular Dx
This article was originally published in The Gray Sheet
The firm, soon to be acquired by Danaher, is pursuing a major data collection effort to gain reimbursement for its ultrasensitive prostate cancer assay, following a 300-patient trial to support 510(k) clearance.
You may also be interested in...
The Clinical Laboratory Of The Future: Can Technology Fill The Gaps?
Clinical laboratories in the US and Europe are facing pressure from all sides as budget cuts and staffing shortages compete with a growing demand for ever-more-sophisticated lab tests to serve an aging population. As a result, lab directors are seeking innovative ways to improve efficiency and do more with less, and those goals are driving innovation in technology-based solutions such as laboratory automation and informatics. These solutions are increasingly becoming integrated into the total laboratory process – encompassing not only sample analysis, but also up- and downstream workflows – paving the way for the fully integrated, automated lab of the future.
Danaher Expands Diagnostics Offerings Via $338 Mil. IRIS Acquisition
Firm will combine IRIS International with its Beckman Coulter diagnostics unit. Deal adds leading worldwide provider of automated urine microscopy and chemistry systems, including IRIS’ fully-automated iQ bench-top analyzer for urine microscopy.
Pink Sheet Podcast: Moderna CEO On Capitol Hill, Xtandi March-In Rights, Tofersen Adcomm In ALS
Pink Sheet reporter and editors discuss Moderna CEO’s Stéphane Bancel’s defense of his company and COVID-19 vaccine pricing at the Senate Health, Education, Labor and Pensions Committee, the NIH denying a petition to use government march-in rights for Xtandi, and Tofersen receiving a positive US FDA advisory committee recommendation for use in ALS.