Burning Rock has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for its OverC Multi-Cancer Detection Blood Test (MCDBT).

OverC MCDBT is designed for the early detection of multiple cancer types such as oesophageal, liver, lung, ovarian, and pancreatic cancers in adults, aged 50-75 years.

The blood test has shown a 69.1% of sensitivity and 98.9% of specificity in the case-control study, dubbed THUNDER.

The Chinese biotechnology company aims to further validate the test in prospective interventional studies among the asymptomatic population.

Burning Rock founder and CEO Yusheng Han said: “We are very excited that our cfDNA methylation multi-cancer early detection technology has received FDA Breakthrough Device Designation.

“For cancer, early diagnosis and treatment are the key to the long-term survival of patients. Liquid biopsy-based early detection technology will be an important supplement to the current cancer screening methods, especially for ovarian cancer, pancreatic cancer and other cancers that have no effective screening methods up to now.”

According to Burning Rock, liquid biopsy has the potential to increase detection efficiency and enable early diagnosis and treatment, compared to conventional screening methods.

In 2016, the company started the development of multi-cancer early detection technology based on DNA methylation technology.

The OverC MCDBT will improve survival and quality of life, while reducing the social burden of the disease on patients, said the company.

Last year, Burning Rock received the CE mark for its OverC MCDBT, manufactured in both the US and China facilities.

The US FDA grants Breakthrough Device Designation to certain medical devices that provide for more effective treatment or diagnosis of life-threatening diseases.

The designation will clear the path for registration, and performance validation and help establish the utility of its OverC MCDBT, said Burning Rock.

Yusheng added: “Burning Rock has also launched two prospectively collected case-control studies, PREDICT and PRESCIENT, with more than 10,000 subjects to be enrolled, to continue developing OverC MCDBT to cover more cancer types.

“With our promising clinical research data, we believe that over time our collective effort is going to make a significant impact towards the improvement of cancer patients’ lifespan and quality of life.”

Burning Rock is a Chinese biotechnology company, focused on applications of next-generation sequencing (NGS) technology in the field of precision oncology.