Using BGI's sequencing technology, the firms plan to commercialize Natera's Signatera test in China and to develop reproductive health tests in "select markets."
The ctDNA test will be covered for all US fee-for-service Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.
Data being presented at the upcoming AACR meeting show that Guardant's liquid biopsy test provided more accurate and rapid mutation detection than tissue genotyping.
The assay monitors mutations across a patient's genome and matches them to mutations found in a patient's resected tumor and in DNA in the bloodstream.
The company received Chinese regulatory approval for a lung cancer assay last year and plans to seek approval for a liquid biopsy test this year.
The researchers believe using cerebral spinal fluid will enable them to identify brain tumors with a higher sensitivity than with blood samples.
The firm's has expanded its ctDNA sequencing test to cover 17 genes, enough to provide a readout of microsatellite instability for guiding cancer immunotherapy use.
The firm's new RT-PCR assay identifies 20 gene fusion between NTRK1/2/3 and other genes, allowing clinicians to potentially detect rare forms of different cancers.
The firm is moving into a larger facility after its first full year of profitability and planning new hires to support its plans to bring liquid biopsy kits through the FDA.
Plans are in place for a Guardant360-based assay to predict response to AsztraZeneca's Tagrisso and for a blood-based TMB test using the larger GuardantOmni panel.