Press & Media

PlexBio Receives CE Mark for IntelliPlex™ Lung Cancer Panel


Taipei, Taiwan – October 31, 2018 - PlexBio Co., Ltd, an emerging multi-national diagnostic company, announced today that it has received CE mark for its IntelliPlex™ Lung Cancer Panel, an in vitro molecular diagnostic assay intended for the qualitative identification of 36 DNA mutations in the KRAS, NRAS, PIK3CA, BRAF and EGFR genes as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1 and MET genes from formalin-fixed paraffin-embedded (FFPE) tumor tissue from lung cancer patients.

Studies of Non-Small Cell Lung Cancer (NSCLC) tumors have identified recurrent 'driver' mutations that occur in multiple oncogenes, including AKT1, ALK, BRAF, EGFR, HER2, KRAS, MEK1, MET, NRAS, PIK3CA, RET, and ROS1, and these markers serve as the basis for the molecular classification of NSCLC. Both DNA mutations and gene rearrangements contribute to oncogenesis in NSCLC.

Targeted small molecule inhibitors and biologics are available or being developed to benefit specific subsets of NSCLC patients who are classified on the molecular basis of their individual mutations. As a result, the assessment of the specific mutation type(s) present across multiple oncogenes has become critical in the evaluation of cancer treatments. PlexBio’s IntelliPlex Lung Cancer Panel enables a rapid multiplex analysis of these mutations with high sensitivity and single-well characterization of specimens containing very small amounts of mutant DNA. This approach, based on the company’s SelectAmp and πCodeTM technologies, also significantly reduces sample requirements and time compared to conventional methods.

PlexBio Chairman and Chief Executive Officer Dr. Dean Tsao said, “The IntelliPlexTM Lung Cancer Panel has been one of our key products under development. And now we are proud to say that the results and feedback that we have been receiving from several testing sites in Europe and APAC regions have been most positive and encouraging. We believe the benchmark established by our IntelliPlex Lung Cancer Panel with FFPE samples will provide the necessary foundation for the application to liquid biopsy as the next step. And we have high confidence the continuing research and development of our expanding menu of oncology panels will yield exciting results in the near future.”

About PlexBio Co., Ltd.: The company established in May 2010, designs, develops and manufactures IVD products and instrumentation from its headquarters in Taipei, Taiwan and its affiliate location in Jiangsu Province, China. PlexBio has also established an Innovative Technology Center in South San Francisco, CA, USA. The company is a listed company at Taiwan emerging stock market.

 

Contact Information:
PlexBio, Co., Ltd.
Address: 6F-1, No. 351, Yangguang St., Neihu District, Taipei City 11491, Taiwan
Tel: +886-2-2627-5878
Fax: +886-2-2627-5979
E-mail: contact@plexbio.com
http://www.plexbio.com