The performance, characteristics, safety, and effectiveness of the PD-L1 Biomarker with Enumeration, CMMC Enumeration, HER2 Biomarker with Enumeration, and CMC Biomarker with Enumeration lab-developed tests have not been cleared or approved by the FDA.
The CELLSEARCH® Circulating Tumor Cell (CTC) test is FDA-cleared for detecting CTCs in cancer patients with metastatic breast, prostate*, or colorectal cancer.
*Metastatic prostate cancer patients were defined as having two consecutive increases in the serum marker prostate-specific antigen above a reference level, despite standard hormonal management. These patients are commonly described as having androgen-independent, hormone-resistant, or castration-resistant prostate cancer.
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