Receive our newsletter – data, insights and analysis delivered to you
  1. News
June 19, 2016

Amoy Diagnostics’ AmoyDx ROS1 test supports Phase II trial of crizotinib in lung cancer

China-based medical device company Amoy Diagnostics has reported positive results from its AmoyDx ROS1 test while supporting the OxOnc Development during the completion of Phase II trial (OxOnc study) of crizotinib in East Asian patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).

China-based medical device company Amoy Diagnostics has reported positive results from its AmoyDx ROS1 test while supporting the OxOnc Development during the completion of Phase II trial (OxOnc study) of crizotinib in East Asian patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).

The ROS1 gene fusions test is a nucleic acid amplification test for the qualitative detection of ROS1 gene fusions in NSCLC formalin-fixed, paraffin-embedded (FFPE) samples.

The test kit involves a specimen preparation to classify the total RNA from NSCLC FFPE samples then reverse transcription of the target RNA to generate complementary DNA (cDNA).

"We expect NSCLC patients with ROS1 translocations to benefit significantly from the OxOnc Study results."

It uses real-time PCR technology to test the tumour messenger RNA from human tumour tissue or tumour cells and deliver the results in 2.5 hours.

Around 127 ROS1-positive patients in China, Japan, Taiwan and South Korea were enrolled in the trial, which met its primary objective of showing a high overall response rate for crizotinib.

AmoyDx CEO and president Dr Zheng said: "We expect NSCLC patients with ROS1 translocations to benefit significantly from the OxOnc Study results.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 
Ensuring quality and supply chain visibility for medical device components

"AmoyDx aims to provide our customers with superior and innovative products and services to improve healthcare and patient well-being, and in particular, contribute to the development of new cancer therapies and precision medicine."

AmoyDx has secured the CE mark for its ROS1 kit detecting 14 ROS1 gene fusions in Europe in 2013 and received Chinese Food and Drug Administration (CFDA) approval in 2014.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU