Burning Rock Says FDA Grants Breakthrough Device Designation For OverC Multi-Cancer Blood Test

RTTNews | 847 dagar sedan
Burning Rock Says FDA Grants Breakthrough Device Designation For OverC Multi-Cancer Blood Test

(RTTNews) - Burning Rock (BNR), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced Tuesday that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

Under the FDA's Breakthrough Devices Program, the Breakthrough Device Designation is granted to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions such as cancer.

OverC MCDBT is intended for early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75 years old, at average risk for cancer.

Burning Rock received CE mark for its OverC MCDBT manufactured in both the US and China facilities. The FDA Breakthrough Device Designation granted for it would pave the way for a clearer registration path through confirmative performance validation and utility establishment.

read more
Swiss Market Closes Modestly Higher

Swiss Market Closes Modestly Higher

The Switzerland market ended modestly higher on Tuesday after holding firm right through the day's trading session. Reports that the U.S. would move to reduce the impact of duties imposed on foreign parts in domestically manufactured cars helped underpin sentiment.
RTTNews | 2h 6minuter sedan
European Stocks Close Broadly Higher As Investors React To Earnings

European Stocks Close Broadly Higher As Investors React To Earnings

European stocks closed broadly higher on Tuesday with investors reacting to a spate of corporate earnings announcements, and continuing to assess the U.S. Government's trade policy. Reports that the U.S. President has proposed lower tariffs on auto parts for U.S.-produced vehicles helped keep investor sentiment positive.
RTTNews | 2h 26minuter sedan
Canadian Market Up Marginally In Cautious Trade

Canadian Market Up Marginally In Cautious Trade

Canadian stocks are swinging between gains and losses on Tuesday as investors make cautious moves, monitoring the developments on the tariff front, and reacting positively to the victory of Prime Minister Mark Carney's victory in the general election.
RTTNews | 3h 21minuter sedan
Dollar Index Edges Up Amidst Trade Deal Uncertainty

Dollar Index Edges Up Amidst Trade Deal Uncertainty

The U.S. dollar recorded a mixed performance against major currencies during the week ended April 25 amidst continuing uncertainty in respect of U.S. trade policy and oscillating expectations about a trade deal, particularly with China.
RTTNews | 4h 32minuter sedan
U.S. Consumer Confidence Slumps More Than Expected In April

U.S. Consumer Confidence Slumps More Than Expected In April

Largely reflecting a significant deterioration by consumer expectations, the Conference Board released a report on Tuesday showing its U.S. consumer confidence index slumped by more than expected in the month of April. The Conference Board said its consumer confidence index plunged to 86.0 in April from an upwardly revised 93.9 in March.
RTTNews | 5h 20minuter sedan