Boston Cell Standards nabs FDA clearance for IHC test panel

Boston Cell Standards on Thursday announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its immunohistochemistry IHControls panel for evaluating breast cancers.

The firm’s IHControls are quantitative linear on-slide quality controls used to ensure that immunohistochemistry tests are performed correctly by matching the control concentration to the assay, Boston Cell said. They can detect variations in IHC reagents, reagents, instruments, or protocol, the company added.

“IHControls represent a giant step forward in standardization in the anatomic pathology lab, especially in detecting low estrogen receptor-expressing tumors,” Dr Matthias Szabolcs, director of the immunohistochemistry laboratory at Columbia University Medical Center/New York-Presbyterian Hospital, said in a statement. “IHControls may give anatomic pathologists the ability to increase positive predictive value, allowing us to determine which patients will benefit, and by how much.” LabPulse