- China-based biotech Burning Rock Biotech Limited ( NASDAQ: BNR ) added ~9% in the morning hours Tuesday after announcing that the FDA issued its Breakthrough Device Designation for the company’s multi-cancer detection test OverC.
- The blood-based test is designed for the early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic) in average-risk adults aged 50-75 years.
- The test is undergoing studies in asymptomatic individuals and has indicated a 69.1% sensitivity and 98.9% specificity in the case-control study, THUNDER.
- The FDA grants Breakthrough Device Designation for medical devices which has the potential to become effective treatment or diagnosis of fatal or irreversibly debilitating medical conditions.
- The FDA has designed the program to speed up the development and review of breakthrough medical devices intending to provide timely access to such devices.
- Read: Issuing a Hold rating on Burning Rock ( BNR ), Seeking Alpha contributor Donovan Jones flags COVID-related risk to the company’s topline.
For further details see:
Burning Rock spikes on FDA breakthrough device designation for cancer test