SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2023
Commission File Number: 001-39316
BURNING ROCK BIOTECH LIMITED
No.5 Xingdao Ring Road North, International Bio Island
Peoples Republic of China
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
Exhibit 99.1 of this current report on Form 6-K (the Report) shall be incorporated by reference into the Companys registration statements on Form F-3, which became effective on September 30, 2022 (File no. 333-264577).
SAFE HARBOR STATEMENT
The press release included in Exhibit 99.1 of this Report, including the quotes from the Companys management team, contains forward-looking statements. These statements constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as will, expects, anticipates, future, intends, plans, believes, estimates, target, confident and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rocks beliefs and expectations, are forward-looking statements. Such statements are based upon managements current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rocks control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.
Description of Document
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Burning Rock Biotech Limited
Chief Financial Officer
Date: January 4, 2023
Burning Rock Received FDA Breakthrough Device Designation for its OverC Multi-Cancer Detection Blood Test
IRVINE, Calif. Jan.03, 2023 - Burning Rock (NASDAQ/LSE: BNR), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced 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 FDAs 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. This program is designed to provide patients and healthcare providers with timely access to medical devices granted the designation by speeding up their development, assessment, and review.
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. OverC MCDBT demonstrated a 69.1% of sensitivity and 98.9% of specificity in the case-control study, THUNDER, and will be further validated in prospective interventional studies among asymptomatic population. Test results of Detected with the top one or two predicted tissues of origin of cancer-associated signals may indicate the presence of cancer and should be followed up by diagnostic tests suggested by qualified healthcare professionals in accordance with professional guidelines. Test results of Undetected do not rule out the presence of cancer, and individuals should continue with guideline-recommended standard of care screening tests.
Compared with conventional cancer screening methods, liquid biopsy has the potential to increase detection efficiency and enable early diagnosis and
treatment, thus improving patients survival and quality of life while reducing social burden of the disease. Burning Rock started development of multi-cancer early detection technology based on DNA methylation in 2016, and the technology and
validation data have been presented at ASCO (available at https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.10544), ESMO (available at https://oncologypro.esmo.org/meeting-resources/esmo-
congress/a-multi-cancer-early-detection-model-based-on-liquid-biopsy-of-multi-omics-biomarkers-a-proof-of-concept-study-promise-study) and other medical conferences, as well as journals such as Nature Biomedical Engineering , demonstrating high specificity, sensitivity, and accuracy in predicting the tissue of origin. In May 2022, Burning Rock received CE mark for its OverC MCDBT manufactured in both the US and China facilities. Today, the FDA Breakthrough Device Designation granted for OverC MCDBT would pave the way for a clearer registration path through confirmative performance validation and utility establishment.
1 / 3
Mr. Yusheng Han, founder and CEO of Burning Rock, 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. 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 significant impact towards the improvement of cancer patients lifespan and quality of life.
 Liang N, Li B, et al. Ultrasensitive detection of circulating tumour DNA via deep methylation sequencing aided by machine learning. Nat Biomed Eng. 2021 Jun;5 (6):586-599.
2 / 3
About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
For more information about Burning Rock, please visit: www.brbiotech.com.
3 / 3