NEW YORK — SeekIn said on Wednesday that it has received CE marking for its SeekInClarity Cancer Treatment Response Monitoring Kit.
The Shenzhen, China-based biotech said that it is now ready to launch the kit in Europe and other countries that recognize the CE mark.
The liquid biopsy assesses cancer treatment response through changes in circulating tumor DNA.
In a statement, SeekIn Founder and CEO Mao Mao said that the kit was developed based on shallow whole-genome sequencing and protein analysis in blood. It uses a molecular response index model to obtain a molecular tumor burden to "capture the overall genomic landscape of a tumor and better evaluate the efficacy of various therapies including chemotherapy, targeted therapy, immunotherapy, or combination therapy," he said.
SeekIn plans to seek global regulatory approvals in other territories as well, such as in China and Japan. The company also recently obtained CE marking for its SeekInCare pan-cancer early detection kit and for its LeukoPrint Molecular Karyotyping Kit for the diagnosis and stratification of leukemia patients.