NowDx's First to Know Syphilis Test received FDA authorization in August, making it the first over-the-counter syphilis test to be authorized by the agency.
The company continues to build validation data and believes its lower cost proposition can help it gain leverage in the European market where molecular tests are not reimbursed.
The test is approved for patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.
The researchers used the CellSearch assay to measure circulating tumor cells and determine the response to certain treatments as well as survival outcomes.
CyPath Lung is a laboratory-developed assay that uses self-collected sputum samples treated with a fluorescent compound that preferentially binds to cancer cells and cancer-related cells, San ...
NowDx's First to Know Syphilis Test received FDA authorization in August, making it the first over-the-counter syphilis test to be authorized by the agency.