Biovica, active in cancer monitoring, today announces that the company’s test laboratory in San Diego, California, has received CLIA certification allowing Biovica to begin commercial sales of DiviTum® TKa on the US market.
“The CLIA certification is a critical step for the launch of our recently FDA cleared DiviTum® TKa diagnostic test, and we can now begin our US commercial launch. Our team is committed to executing our go-to-market plan and look forward to contributing to the benefit of metastatic breast cancer patients,” said Warren Cresswell, President of the Americas.
The Clinical Laboratory Improvement Amendment (CLIA) program, governed by the Centers for Medicare & Medicaid Services (CMS), is intended to regulate labs that perform laboratory testing and diagnostics on human specimens to maintain the accuracy, reliability, and reporting of patient test results. Biovica’s certificate was granted by California Department of Public Health.