August 2008: Volume 34, Number 8
FDA Approves New Genetic Breast Cancer Test
Invitrogen announced the FDA approval of its SPOT-Light HER2 CISH test kit that determines whether a patient with breast cancer is a good candidate for treatment with Herceptin. Current medical practice requires that all patients who are considered for Herceptin treatment be tested for HER2 amplification or overexpression. The test uses a DNA probe for the HER2 gene that’s amplified in 18%–30% of breast cancers, helping predict whether a breast cancer patient is a candidate for Herceptin treatment. Results of the test, which is based on chromogenic in situ hybridization (CISH), are visualized under a standard bright-field microscope—as opposed to FISH tests, where the results must be visualized using a fluorescent microscope. The HER2 CISH test results are quantifiable, removing the subjectivity of tests based on immunohistochemistry (IHC) interpretation. And unlike other tests, the SPOT-Light kit allows the lab to store the tissue for future reference.
HemoCue’s Albumin 201 Gets CLIA Waiver
HemoCue AB announced that the FDA granted a CLIA waiver for its Albumin 201 system, making it the first quantitative, point-of-care waived test for screening for, diagnosing, and monitoring microalbuminuria. The urine-based system is designed so that non-laboratory-trained physicians and other healthcare professionals can screen patients for microalbuminuria and begin treatment based on the test’s results within a single office visit.
Colorectal Cancer Monitoring Test Cleared
ADL announced FDA clearance of its AMDL-ELISA DR-70 (CRC) blood test for post-surgery monitoring of patients who have been previously diagnosed with colorectal cancer. According to ADL, because carcinoembryonic antigen (CEA), the basis for the currently accepted monitoring test, can have normal values in some patients who are biopsy-positive for cancer, oncologists need an additional test for monitoring those patients who are CEA negative yet have biopsy-confirmed colorectal cancer. ADL’s test is the first FDA-cleared monitoring test since the 1982 approval of CEA.