Roche’s Blood Test to Measure Lp(a) Receives the US FDA’s Breakthrough Device Designation, Enhancing its Cardiovascular Portfolio
Shots:
- The US FDA has granted breakthrough device designation to the company’s Tina-quant lipoprotein Lp(a) RxDx assay for finding out patients who may take advantage from Lp(a)-lowering therapy under development and for HCPs to make precise decisions
- Developed in partnership with Amgen, the test is designed to be utilized in patients with increased lipoprotein Lp(a) and a history of atherosclerotic disease intended to be treated with an Lp(a) lowering drug
- The test works by measuring number of Lp(a) molecules per litre from the patient’s blood sample to serve as an actionable biomarker in the future. It will be available on cobas platforms once approved
Ref: Roche | Image: Roche
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
