Fluidigm Corp. (NASDAQ: FLDM) made a splash with the markets on Wednesday morning after the company announced a critical update from the U.S. Food and Drug Administration (FDA) in regards to its COVID-19 test.
Fluidigm has received Emergency Use Authorization (EUA) from the FDA for its saliva-based test, the Advanta Dx SARS-CoV-2 RT-PCR Assay. It is designed to be run on the Fluidigm Biomark HD microfluidics platform.
With this approval, the firm helps alleviate the constrained supply chain for testing within the United States. The Biomark HD platform can generate as many as 6,000 test results per day on a single system.
The test is saliva based and therefore less invasive than the standard nasopharyngeal swab. Also, the clinical study associated with the EUA submission demonstrated a 100% agreement between the saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and the results from paired nasopharyngeal samples tested with authorized assays.
The Advanta Dx SARS-CoV-2 RT-PCR Assay was developed in collaboration with scientists at the McDonnell Genome Institute and the Department of Genetics at the Washington University School of Medicine in St. Louis.
Management noted that it has a high degree of confidence that this new test will not only enhance testing capacity but also will significantly improve speed to results and scale. The ease of use for health care providers and patients alike will enable improved testing access to the U.S. and global population.
Excluding Wednesday’s move, Fluidigm stock had vastly outperformed the broad markets with a gain of about 152% year to date. In the past 52 weeks, the share price was closer to 65% higher.
Fluidigm stock traded up about 23% at $10.80, in a 52-week range of $1.17 to $12.45. The consensus price target is $12.67.