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Cancer is the second most significant cause of death worldwide, with annual increases in both incidence and mortality.
FREMONT, CA: In-vitro diagnostics is a term that refers to a subset of tests or medical devices that assess specimens obtained from the human body and provide critical information for screening, diagnosis, and therapy.
Early detection via In-vitro diagnostics
In-vitro diagnostics are crucial for clinical decision-making in the screening, diagnosis, and treatment of cancer.
These include cytology, surgical pathology, flow cytometry, and molecular testing. Fluid biomarkers for cancer are proteins or other substances produced in more significant quantities by cancer cells than normal cells. Cancer patients' blood, urine, stool, or other body fluids may include these chemicals. AFP is a hepatocellular cancer screening biomarker. Another example is the FIT used to screen for colorectal cancer. The FIT detects human hemoglobin, indicating GI hemorrhage. Genomic markers such as tumor gene mutations, gene expression patterns, and nongenetic changes in tumor DNA are increasingly used in diagnostic pathology and blood or other fluid tests.
Additionally, IVD testing can provide vital information about a patient's health, such as the likelihood of developing a specific cancer type, the stage, and the possibility of remission after treatment. IVD testing may involve screening for human papillomavirus (HPV), which has been linked to cervical cancer, and detecting the existence of a bcr-abl fusion gene to
determine whether or not to use imatinib to treat chronic myeloid leukemia (CML). Thus, IVDs aid in the selection of appropriate therapy options following diagnosis.
New IVDs, including point-of-care (POC) and self-testing, is accurate and cheap. The second WHO Model List of Essential In-vitro Diagnostics for Use in Clinical Laboratories (WHO EDL) includes more and more cancer IVDs, showing their growing importance in cancer prevention, treatment, and care. For example, IVDs can detect cancer-causing infections like HPV and HCV and genetic and biomarker tests for many cancers. IVDs are integral to the cancer care process and cannot be ignored. Access to adequate diagnostic testing and quality-assured treatment is required across the continuum of care. Patients with breast cancer, for example, need tamoxifen before or after surgery to improve outcomes. New and breakthrough targeted medications have revolutionized several malignancies. Tumors are treated with monoclonal antibodies (e.g., pembrolizumab). However, BRAF inhibitors are used to treat malignancies like metastatic melanoma that had no prior treatment. However, these tailored drugs are only successful when paired with diagnostics. Companion diagnostics help determine whether focused therapy is suitable for a patient. For example, imatinib helps cure CML. It should only be used in leukemia cells with the bcrabl fusion protein, which can be detected cytogenetic or molecularly. All three drugs (tamoxifen, pembrolizumab, and BRAF inhibitors) require similar companion diagnostics (BRAF testing of tumor cells).
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