Cervical cancer is the fourth most common type of cancer among women worldwide. It is estimated that every year, more than 500,000 women are diagnosed with cervical cancer globally, and around 250,000 women die from the disease.

The most common cause of cervical cancer is human papillomavirus (HPV) infection. However, if detected early, the disease is highly curable.

Regular cervical cancer screening is crucial for early detection of the disease. Currently, the Pap smear test is the standard screening method for cervical cancer.

However, the test has a high rate of false-negative results, which means that a significant number of women receive false reassurance, and their cancer may go undetected until it becomes advanced.

Roche, a global leader in diagnostics, has recently announced the development of a new detection test for cervical cancer.

The test, called CINtec® PLUS Cytology, is designed to provide more accurate results than the Pap smear test, and it is expected to revolutionize cervical cancer screening.

How does CINtec® PLUS Cytology work?

CINtec® PLUS Cytology is a non-invasive test that uses advanced biomarkers to detect the presence of cervical pre-cancer and cancer cells.

The test works by identifying two biomarkers, p16 and Ki-67, which are found in high levels in pre-cancer and cancer cells.

The test starts with taking a cervical sample, similar to the Pap smear test. The sample is then analyzed using immunocytochemical staining, a technique that uses specific antibodies to detect the biomarkers p16 and Ki-67.

The results of the test are interpreted based on the level of biomarker expression, and the presence of abnormal cells on the cervical sample.

How is CINtec® PLUS Cytology better than the Pap smear test?

The Pap smear test has been the standard screening method for cervical cancer for over 50 years. However, the test has several limitations that make it less effective than CINtec® PLUS Cytology.

Firstly, the Pap smear test has a high rate of false negatives, which means that women with pre-cancer or cancer cells can receive a negative test result and be falsely reassured.

Secondly, the test has a low sensitivity, which means that it can miss up to 50% of pre-cancer and cancer cases. Finally, the test requires an experienced pathologist to interpret the results, which can result in interobserver variability and errors.

In contrast, CINtec® PLUS Cytology has several advantages over the Pap smear test. Firstly, the test has a higher sensitivity and specificity, which means that it can detect more cases of pre-cancer and cancer.

Secondly, the test is easier to interpret, as it does not rely on the visual analysis of the cervical sample. Thirdly, the test can be automated, which eliminates interobserver variability and reduces errors.

What are the benefits of CINtec® PLUS Cytology?

CINtec® PLUS Cytology has several benefits over the Pap smear test, including:.

Higher sensitivity and specificity
Reduced false-negative results
Easier interpretation
Reduced interobserver variability and errors
Faster turnaround times
Ability to retest samples

In addition, CINtec® PLUS Cytology can identify pre-cancerous lesions earlier than the Pap smear test, which means that women can receive treatment earlier, reducing the risk of developing cervical cancer.

When will CINtec® PLUS Cytology be available?

CINtec® PLUS Cytology is expected to be available for use in Europe in the second half of 2021. The test has already received the CE mark, which means that it complies with European Union requirements for health, safety, and environmental protection.

Roche is also seeking approval from the US Food and Drug Administration (FDA) for the test to be used in the United States. If approved, CINtec® PLUS Cytology will be the first biomarker-based test for cervical cancer in the US market.

Conclusion

Cervical cancer is a significant public health problem, affecting millions of women worldwide. Regular screening is crucial for early detection of the disease, but the Pap smear test has several limitations.

The development of CINtec® PLUS Cytology by Roche is a significant advancement in cervical cancer screening, as the test is expected to provide more accurate results and revolutionize the way cervical cancer is screened. With early detection, cervical cancer is highly curable, and the new test has the potential to save countless lives.