Boston Cell Standards’ IHControls Panel Gets 510(k) Clearance
Boston Cell Standards received 510(k) clearance from the FDA for its IHControls panel for the evaluation of breast cancers.
The test panel is used to help healthcare professionals determine which patients will benefit from specific types of treatment as well as how much they are likely to benefit.
The IHControls panel, which detects HER2, estrogen receptor (ER) and progesterone receptor levels, has the ability to detect low ER-expressing tumors.
IHControls also features immunohistochemistry (IHC) reference panels that verify IHC assay accuracy. Rates of clinically inadequate IHC testing are roughly 10 times that of clinical blood testing labs, with ICH test discrepancy rates of 10 to 30 percent, the company said.