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Genetron Health Gets China NMPA Approval for Clinical NGS System, Files for IPO

NEW YORK – Genetron Health announced that China's National Medical Products Association has approved the firm's clinical next-generation sequencing system.

The Genetron S5 is a benchtop instrument based on the Thermo Fisher Scientific Ion GeneStudio S5 system for targeted NGS. Genetron Health has also developed liquid biopsy assays for use on the system, including tests for breast cancer, lung cancer, thyroid cancer, glioma, and urothelial carcinoma. The firm said the system can be used in early screening, diagnosis, treatment guidance, and disease monitoring in cancer, with additional applications in genetic and infectious disease research.

Genetron Health said the S5 offers testing in as little as two days, using a proprietary, patented One-Step Seq library construction method, that uses as little as 10 nanograms of sample DNA. The system can handle between 2 million and 130 million reads per run.

"The approval of Genetron S5 provides another excellent choice for clinical laboratories and adds another powerful instrument for the standardization of molecular diagnosis," Genetron Health CEO and Cofounder Sizhen Wang said in a statement. "Genetron S5 will deliver high-quality laboratory testing while providing data for clinical use and precision medicine in a much faster manner."Genetron Health did not disclose other details of the NMPA approval.

Additionally, Genetron Holdings, a Cayman Islands-based holding company associated with Genetron Health has filed a Form S-1 with the US Securities and Exchange Commission for an initial public offering of American depositary shares. The firm has not yet priced the offering but plans to use the proceeds to invest in R&D, expand its sales and marketing efforts, and for working capital and general corporate purposes. It proposes to trade on the Nasdaq under ticker symbol "GTH." The offering is being underwritten by Credit Suisse and China International Capital Corporation. 

Founded in 2013 and based in Beijing, Genetron Health offers genomics products and services, including PCR instruments and cancer sequencing. The firm also has a research center in the Research Triangle area of North Carolina.

In March, Genetron Health published data on blood-based early detection of viral liver cancer in the Proceedings of the National Academy of Sciences.

According to the prospectus filed with the SEC, Genetron Holdings said it has obtained effective control and is the primary beneficiary of Genetron Health through "a series of contractual arrangements" with Genetron Holding's wholly-owned subsidiary, Genetron (Tianjin).

Genetron Holdings recorded total revenue of $31.5 million in 2018, with a net loss of $65.1 million. Genetron Health performed approximately 15,600 tests in 2018, up from approximately 6,700 tests in 2017.

As of Sept. 30, the firm had $754,000 in cash and cash equivalents, but last month, the firm issued approximately 15.2 million Series C preferred shares to Vivo Capital Fund IX for $15 million and issued approximately 34 million Series D preferred shares to Vivo, CICC Healthcare Investment Fund, Alexandria Venture Investments, Giant Plan, and ETP BioHealth II Fund for $50 million. The firm has also agreed to issue approximately 6.8 million Series D preferred shares "or [a] corresponding number of ordinary shares subject to Series D conversion mechanism" to CICC Healthcare for $10 million.

Prior to the issuances, Genetron Holdings repurchased approximately 6.9 million preferred shares and 8.2 million ordinary shares from certain shareholders for a total of $15 million.China's NMPA was formerly known as the China Food and Drug Administration.