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FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
Hologic has been on the vanguard of developing and distributing tests focusing on women’s health
New liquid biopsy assay will be used in conjunction with 500 cancer patients currently enrolled in clinical trials
The company’s patients can use AI to look at trends going back five years
Proper dosing helps prevent potential side effects such as developing diabetes and kidney damage
Biotech giant purchased the company for $21 billion, one of the largest deals in clinical lab history
In both cases, the diagnostic tests report results back within 15 minutes
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
The flow cytometry assay costs a fraction of traditional invasive bone marrow testing
The test offers a 76 percent sensitivity to detection of stage 1 and stage 2 pancreatic cancers
