Diagnostic executives say the revenue-based excise tax has curtailed innovation and investment across the industry, and they expect a repeal would spur job creation.
Since purchasing the bioscience unit of Sequenom four years ago, Agena has followed global growth by pushing into more clinical labs in China, as well as Europe.
At least one HIV self-test from a competitor could reach the global market this year. In addition, the company is in the midst of a strategic review.
The company plans to commercialize a gene expression signature to predict recurrence risk in cutaneous squamous cell carcinoma.
Digital pathology has been relegated to research use only in many smaller labs, but an FDA approval last year, and more options targeted to them, may change that.
The firm also offers an NIPT, codeveloped with Yale, that its CEO said is differentiated by its rapid time-to-result.
The firm recently announced a $3.15 million grant from the NIH, and it supported work that resulted in the first-ever digital primary diagnosis of a suspected cancer case.