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Genetron Health Tops NCCL’s External Quality Assessment of NGS-based Comprehensive Genomic Profiling for Solid Tumors with Full Marks

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Genetron Health (NASDAQ: GTH), a leading precision oncology platform in China, announced that its Beijing clinical laboratory achieved full marks in the National Center for Clinical Laboratories' first nationwide external quality assessment for NGS-based genomic profiling. Ranking first among 63 participating labs, Genetron demonstrated zero reproducibility errors and false negatives, confirming its high-quality operational standards. The company has maintained full marks for six consecutive years and holds significant international certifications, including CAP, CLIA, and ISO15189, enhancing its reputation in precision medicine.

Positive
  • Achieved full marks in NCCL's EQA for NGS-based genomic profiling.
  • Ranked first among 63 participating laboratories.
  • Demonstrated zero reproducibility and false negative errors.
  • Maintained full marks for six consecutive years in external assessments.
  • Holds three international laboratory quality certifications: CAP, CLIA, and ISO15189.
Negative
  • None.

BEIJING, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Genetron Holdings Limited (“Genetron Health” or the “Company”, NASDAQ: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today announced that its Beijing clinical laboratory has received full marks under the National Center for Clinical Laboratories’ (“NCCL”) first nationwide, external quality assessment (“EQA”) of NGS-based comprehensive genomic profiling for solid tumors. The clinical laboratory passed the assessment with flying colors, earning the designation “Outstanding Laboratory” and receiving full marks, ranking first among all of the 63 laboratories that participated in the evaluation.

High-throughput next generation sequencing (“NGS”) technology has been widely used in precision medicine. NGS-based comprehensive genomic profiling tests are able to cover more genes and mutations, and can direct patients towards more accurate treatment solutions. As such, comprehensive genomic profiling tests are increasingly becoming a trend in the clinical applications of precision oncology.

In order to improve clinical laboratories’ NGS-based comprehensive genomic profiling capabilities in China, the NCCL carried out a nationwide assessment for the first time. The assessment aims to point out various and common issues experienced by laboratories in the industry, and to improve the quality of industry practices.

A total of 63 laboratories from 12 different provinces and municipalities in China participated in the EQA. Among the 63 valid results, 25.4% (16/63) had no reproducibility errors, 12.7% (8/63) had no false negative results, and 61.9% (39/63) had no false positive results. Genetron Health participated in the assessment using its proprietary NGS-based comprehensive genomic profiling product, Onco PanScan and achieved full marks without any errors.

Genetron Health’s laboratories strictly adhere to a full-cycle quality control system. The Company has passed NCCL’s EQAs with full marks for six consecutive years, attesting to its accurate detection capabilities and high quality operational standards. At present, Genetron Health’s laboratory in Beijing has obtained three international laboratory quality certifications: CAP, CLIA and ISO15189, becoming one of the few NGS laboratories in China to possess them.

About Onco PanScan™
Onco PanScan™ is Genetron’s comprehensive genomic profiling test that is based on hybridization capture NGS technology. Onco PanScan™ provides comprehensive and accurate genomic profiling to guide personalized medicine for cancer patients with a single test, making it suitable for targeted therapy, chemotherapy, and immunotherapy treatment guidance. Onco PanScan™ covers hundreds of genes recommended by professional treatment guidelines, including WHO, NCCN, ESMO and others. In January 2020, the National Medical Products Administration (“NMPA”) initiated device inspection process for Onco PanScan™, which is part of the IVD registration process in China.

About Genetron Holdings Limited
Genetron Holdings Limited (“Genetron Health” or the “Company”) (Nasdaq:GTH) is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive oncology portfolio that covers the entire spectrum of cancer management, addressing needs and challenges from early screening, diagnosis and treatment recommendations, as well as continuous disease monitoring and care. Genetron Health also partners with global biopharmaceutical companies and offers customized services and products. For more information, please visit ir.genetronhealth.com.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of federal securities laws which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as “may”, “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

Investor Relations Contact
US:
Hoki Luk
Email: hoki.luk@genetronhealth.com
Phone: +1 (408) 891-9255

Media Relations Contact
Yanrong Zhao
yanrong.zhao@genetronhealth.com


FAQ

What recent achievement did Genetron Health (GTH) announce?

Genetron Health announced that its Beijing clinical laboratory achieved full marks in the NCCL's first nationwide external quality assessment for NGS-based genomic profiling.

How did Genetron Health perform in the NCCL assessment?

Genetron Health ranked first among 63 laboratories, achieving zero reproducibility errors and false negatives.

What certifications does Genetron Health's laboratory hold?

Genetron Health's laboratory has obtained CAP, CLIA, and ISO15189 certifications.

For how many consecutive years has Genetron Health achieved full marks in assessments?

Genetron Health has maintained full marks for six consecutive years in external quality assessments.

What technology does Genetron Health use for genomic profiling?

Genetron Health utilizes NGS-based comprehensive genomic profiling technology, specifically its Onco PanScan™ product.

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