The FDA gave the nod to Shenzhen Bioeasy Biotechnology for two lateral flow immunoassays that provide preliminary results in detecting marijuana in urine.
The test, called ColoPlex and being developed using the xMAP technology, is a blood test that uses multiplexed immunoassay technology and machine learning.
The firm has three clinical trials in progress to validate the clinical utility of products it soon intends to submit for regulatory clearances to the FDA.
The firm said that it placed about 50 sample-to-answer molecular systems under contract during Q1, and it had about 625 active sample-to-answer product customers.
