Researchers conducting oncology trials in China will for the first time have access to circulating tumour cell testing (CTC) under an agreement between US-based diagnostics specialists Veridex and Laboratory Corporation of America Holdings (LabCorp).
Last month Veridex, a Johnson & Johnson company focused on high-value diagnostic oncology products, secured clearance from the China State Food and Drug Administration to market its CelllSearch CTC test as an in vitro diagnostic for women with metatastic breast cancer.
That made CellSearch the first and only approved CTC for cancer patients in China, the seventh country outside the US and the European Union to clear CellSearch for use as an aid to patient monitoring.
Under the agreement with LabCorp, the latter’s LabCorp Clinical Trials division will offer CTC testing on the CellSearch platform to customers conducting clinical trials in China.
In June 2011 LabCorp tapped into a global network of central laboratories, as well as support tools for clinical trial management and personalised medicine, by acquiring existing partner Clearstone Central Laboratories.
Drug developers use CTCs for liquid biopsies, which assess the number and nature of circulating tumor cells in the bloodstreams of study participants. An increase or decrease in the number of CTCs can be an early and strong indicator of a drug’s efficacy.
Circulating tumor cells are cancer cells that have detached from a tumour and are found at extremely low levels in the bloodstream. According to Veridex, its CellSearch test can identify as little as one CTC in 7.5 ml of blood.
“The value of CTCs as an oncology biomarker is well documented in peer-reviewed literature,” commented Robert McCormack, head of technology innovation at Veridex.“As the number of clinical trials in China continues to rise, drug companies conducting trials there now have another compelling reason to incorporate CTCs into their protocols,” McCormack said, adding that local testing will mean faster results for clinical investigators.