AMDL, a Subsidiary of China Biotech Services, is Exclusively Licensed to Distribute FDA Approved Lung & Colon Cancer Companion Diagnostic Assay in Several Asian Regions Including China
Pillar, an invested enterprise of CH BIOTECH SER, received the Premarket Approval ("PMA") on its oncoReveal(TM) Dx Lung and Colon Cancer Assay from FDA on July 30th, 2021.
HONG KONG, Aug 10, 2021 - (ACN Newswire) - China Biotech Services Holdings Limited ("CH BIOTECH SER " or "Company", stock code: 8037.HK) is pleased to announce that Asia Molecular Diagnostic Laboratory ("AMDL"), a subsidiary of the Company, has been exclusively licensed by its shareholder Pillar Biosciences, Inc. ("Pillar") to distribute Pillar's FDA (U.S. Food and Drug Administration) approved oncoRevealTM Dx Lung and Colon Cancer Assay (the "Assay") in part of Asian countries including China (specifically in Guizhou, Sichuan, Liaoning, Hong Kong and Macau), all ASEAN countries & etc. (collectively, the "Regions").
Pillar, an invested enterprise of CH BIOTECH SER, received the Premarket Approval ("PMA") on its oncoReveal(TM) Dx Lung and Colon Cancer Assay from FDA on July 30th, 2021. CH BIOTECH SER currently holds a seat on the board of Pillar.
The Assay is a NGS tissue-based companion diagnostic test for qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The grant of oncoReveal(TM) Dx Lung and Colon Cancer Assay's PMA was based on clinically validated data and allows for the test to be used as a companion diagnostic test for all FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies for NSCLC targeting EGFR mutations (Exon 19 In Frame Deletions and Exon 21 L858R Substitution Mutations), and KRAS wild-type tumor tissue (absence of mutations in codons 12 and 13) for metastatic colorectal cancer patients. It can provide guidance to clinicians when it is necessary to use Erbitux (cetuximab) or Vectibix (panitumumab) for Targeted Therapy. This test is suitable for Illumina MiSeqTM Dx sequencer, which is Illumina's NGS platform for In Vitro Diagnostic (IVD) testing.
NGS is characterized by high throughput, a large amount of sequence data can be obtained at the same time, and the sequencing cost is low when compared to the traditional sequencing method. Since NGS can detect many unknown mutations, this technology has stronger predictive power than PCR-based detection technology. Therefore, the market generally believes that NGS detection technology can replace PCR-based technology in the future and become the mainstream of the market. However, in the current market, whether it is the United States or China, the proportion of approved NGS companion diagnostic products is still small. Take the Chinese market as an example, NGS products began to be approved in 2018, and as of December 2020, there are only 9 NGS products approved in China.
On Jan 10th, 2019, CH BIOTECH SER and Pillar entered into a strategic partnership. Under the terms of their strategic agreement, CH BIOTECH SER and Pillar formed a joint venture, AMDL. AMDL holds the exclusive right to market all the products of Pillar in the Regions. AMDL has set up a clinical molecular diagnostic laboratory in Hong Kong Science & Technology Park. It is dedicated to developing and providing affordable high quality precision diagnostic products and services to the Regions. In the future, Pillar is expected to launch more NGS products for testing other cancers, which will bring more business growth points to CH BIOTECH SER, which has the Pillar's product distribution right. From this perspective, the strategic cooperation between CH BIOTECH SER and Pillar can undoubtedly generate huge synergies, creating new growth points for the company's deployment of accurate diagnostic services in the Asian region, and its intrinsic value will continue to grow with the approval of Pillar's new products.
About Pillar Biosciences, Inc.
Pillar is a clinical cancer diagnostics company based in Boston, Massachusetts and Shanghai, China. It is dedicated to enabling global access to high quality, affordable, and specialty NGS testing. Colombia University, Dana Farber Cancer Institute of Harvard University, Massachusetts General Hospital and Yale University are among Pillar's major clients.
About China Biotech Services Holdings Limited
China Biotech Services Holdings Limited (CH BIOTECH SER) was included in the MSCI Hong Kong Micro Cap Index in May 2018. The main business is the standard pathology laboratory, which is one of the largest third-party medical testing center in Hong Kong. It has been rooted in Hong Kong for 50 years. And for the development of precision diagnosis and cell therapy, it is engaged in cell drug development, medical detection and cancer precision detection and other businesses, and builds an advanced biotechnology platform. There are currently more than 10 CAR-T products under development; four of them have international technology patents; six of them are in patent application. The indications cover B-cell lymphoma and leukemia, as well as several solid tumors with great market potential. During the outbreak of the coronavirus, the Sunrise Diagnostic Centre Limited, a joint venture registered by China Biotech Services and BGI Hong Kong, provided Hong Kong citizens with new coronavirus testing, with remarkable results.
For more information on China Biotech Services Holdings Limited, please visit the company website http://www.cbshhk.com/index.htm/.
This press release is issued by the Porda Havas International Financial Communications Group on behalf of China Biotech Services Holdings Limited.
Porda Havas International Finance Communications Group
Ms. Kelly Fung +852 3150 6763 [email protected]
Ms. Stephanie Yao +852 3150 6737 [email protected]
Ms. Alyssa Yiu +852 3150 6781 [email protected]
Source: China Biotech Services Holdings Limited
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