While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The test, TruGraf, assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection in patients with stable renal function.
The FDA gave the nod to Shenzhen Bioeasy Biotechnology for two lateral flow immunoassays that provide preliminary results in detecting marijuana in urine.
The firm said that its newly CE-marked test for intestinal infections is suitable for use in laboratories and hospitals, and provides results in 90 minutes.
The Scottish researchers have cofounded ClinSpec Dx to commercialize an infrared spectroscopy platform that they said may enable more precise screening for brain cancer.
Chipscreen is developing a small molecule inhibitor of key serine-threonine kinases involved in tumor angiogenesis, cell mitosis, and microenvironment inflammation.
