AMDL, a Subsidiary of CBSH, Is Exclusively Licensed to Distribute FDA Approved Lung & Colon Cancer Companion Diagnostic Assay in Several Asian Regions Including China
发布时间:2021-08-09 19:55:52

We are glad to announce that Asia Molecular Diagnostic Laboratory (“AMDL”), a subsidiary of China Biotech Services Holdings Limited (“CBSH”), 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 CBSH, received the Premarket Approval (PMA) on its oncoReveal Dx Lung and Colon Cancer Assay from FDA on July 30th, 2021. CBSH 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 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.


On Jan 10th, 2019, CBSH and Pillar entered into a strategic partnership. Under the terms of their strategic agreement, CBSH 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.


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.