CA 125: A reliable tool for diagnosis and monitoring treatment of Ovarian cancer.

Initially described by Bast and colleagues in 1981, CA 125 is a repeating peptide epitope of mucin 16 (MUC16), which inhibits anticancer immune responses and promotes cancer cell proliferation. CA125 is an epitope found on MUC16 (sialomucin), a high molecular weight glycoprotein antigen (>200 kDa) present on the cell surface. CA 125 is commonly expressed by primary non-mucinous epithelial ovarian cancers but can also be expressed by various other gynaecologic cancers, including tumours of the cervix, endometrium, and fallopian tube, and by certain non-gynaecologic cancers, including those of the pancreas, breast, colon, lung, liver, kidney, digestive tract, stomach, pericardium, pleura, and thyroid.

One of the most prominent cancers afflicting women both in India and globally is ovarian cancer. Ovarian cancer is the seventh most prevalent type of cancer overall and the eighth most common cause of cancer-related mortality among women. CA125 serves a crucial role as a tumour marker in diagnosing patients suspected of having ovarian cancer and monitoring disease progression. Around 80% of the patients diagnosed with ovarian epithelial carcinoma show elevated CA125 levels. CA125 is the most commonly utilised tumour marker for ovarian cancer and is frequently referred to as the "gold standard." As such, it is the only approved marker for monitoring the progression of ovarian cancer and the efficacy of treatment. As of right now, the most significant and commonly utilised biomarker in clinical practice is CA125.

The National Institute for Health and Care Excellence (NICE) recommended in 2011 that women exhibiting symptoms suggestive of ovarian cancer should have a serum biomarker test for cancer antigen 125 conducted in primary care. NICE suggested that women with an elevated CA125 (≥35 U/ml) should undergo ultrasound testing; however, they did not provide guidance on the follow-up or investigation of women with ‘normal’ (<35 U/ml) CA125 levels. Ireland, Australia, Canada, and the US are just a few of the nations that support CA125 as a primary care test for ovarian cancer.

CA-125 is a tumor-associated antigen that is used to detect the nature of an ovarian cyst. Levels below 35 U/mL are associated with benign conditions, but sensitivity and specificity vary. The presence of other benign conditions can elevate CA-125 levels. The CA125 antigen is normally found in multiple locations within the body. CA125 is present in cervical mucus from healthy women and is likely produced and released from endocervical cells. CA125 is also found in the amniotic fluid and chorionic membrane of the developing foetus in high abundance. It is also expressed in human milk, epithelial cells of airways, respiratory glands, and bronchial mucus. The CA125 blood level may be increased in non-cancerous conditions, including menstruation, pregnancy, endometriosis, pelvic inflammatory disease, non-cancerous ovarian cysts, uterine fibroids, etc.

Yashraj Biotechnology manufactures reliable, high-quality CA 125 native antigens. Extracted directly from human sources, our antigens maintain their natural structure and function, ensuring dependable performance in cancer diagnostics and research.

Specification: Table 1 shows the release criteria for CA 125, manufactured at Yashraj Biotechnology Ltd.

Below is a graphical representation of real-time stability for three finished batches of CA 125 manufactured at Yashraj biotechnology Ltd. The parameter analysed is activity, using the Electrochemiluminescence method over a period of three years.

In a number of immunoassays, biological standards and calibrators can be manufactured from CA 125 antigen. The adaptability and diversity of the CA 125 antigen make it an invaluable resource in the constantly changing field of health care research. Moreover, it is usually used to make single analyte controls, and for multiple tumor marker analyte controls due to the highly reproducible and low cross reactivity of all major cancer antigens such as CA 72-4, CA 19-9, CEA, CA 15-3 etc.