Cervical cancer is something that every woman has to be concerned about. More common in women over the age of 30, cervical cancer can easily go undetected if regular checkups are not performed. In the US alone over 12,000 new cases were reported in 2018 and over 4,000 deaths caused by cervical cancer were reported as well.[1] Just as with many other areas of healthcare there have been many advances in the detection and treatment of cervical cancer in recent years.

Early detection of cervical cancer has been the goal of a lot of research. Detection of precancerous lesions, as opposed to the cancer itself, would help prevent the cancer from even occurring. The World Health Organization recently released guidance for the use of medical devices in the detection and treatment of the precancerous lesions.[2] The guidance sets specifications that should be used for these medical devices with the goal of not only preventing cervical cancer but eliminating it from the world altogether.[2] Even with that guidance in place the standards and regulations of the market those medical devices will be used in still must be followed, for example, the FDA would set the standards and regulations for the US market. Getting a device to market can be a challenge, especially when trying to market a device in an unfamiliar international market.

Unfortunately, early detection of cervical cancer is not always possible, that is where the advances in treatment come in. While chemotherapy is used for most cancers, it is not always effective and has numerous side effects. The FDA recently approved a drug, pembrolizumab, that is meant to be used in combination with chemotherapy to help treat cervical cancer that is persistent, recurrent, or metastatic.[3] Now, the drug is meant to be only in cases where the cervical tumors express a specific marker, that however, does not diminish the accomplishment or the results the drug has shown in survival and progression-free survival.[3]

Cancer is scary, there is no denying that, but as time goes that that fear is being gradually reduced. Researchers are working around the clock to find new treatments and maybe even a cure. EMMA International can help these new treatments and devices reach the market and help the women who need them. From development to FDA approval or the approval of other relevant regulatory bodies, EMMA International can help with it all. EMMA International provides Full Circle Consulting, give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.

[1] CDC (2020) Trends: Cervix, Retrieved 01/02/2022 from https://gis.cdc.gov/Cancer/USCS/#/Trends/

[2] WHO (April 2020) WHO technical guidance and specifications of medical devices for screening and treatment of precancerous lesions in the prevention of cervical cancer, Retrieved 01/02/2022 from https://www.who.int/publications/i/item/9789240002630?

[3] FDA (October 2021) FDA approves pembrolizumab combination for the first-line treatment of cervical cancer, Retrieved 01/02/2022 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-first-line-treatment-cervical-cancer

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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