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Cervical Cancer

February 2018

QUO VADIS PAP TEST?

In 1997, immediately after the NIH 1996 Consensus Conference on Cervical cancer hailed the Pap test as “the best anticancer screening test available” but also accusing it of having high false negative readings rate (about 20%,) we asked JNCI “Can Acid Phosphatase Reduce Pap Test False-negative Readings?”[1]

Today, 20 years after this question was posted, and after years of research and experience, our answer is, YES. In our clinical trials, this rate was decreased to 4% or below 5% an acceptable rate of statistical chance of error. {2]

How this is possible? Now, with all medical progress happened in the meantime, the names have changed, the technology has changed, but the real facts have stayed unchallenged.

The fact is that during maturation of cervical epithelium from the basal to superficial squamous layer, the acid phosphatase is changing the isoenzyme structure if the cell is affected by malignancy.

If one can use the principles of PCR and nanomolecular technology applied on live specimen spread on microscopic slide, he would be able to make this affected isoenzyme visible inside a single, morphological identifiable cell, or the tissue sampled while collecting the specimen. This is an Assay for visualization of metabolic changes leading to morphological changes typical for early diagnosis of the epithelial lesion which could lead to the development of cervical cancer. Koilocytosis or HPV disease is the prognostic parameter here.

We applied this Assay in different clinical trials and results were presented on ASCO meetings [2, 3] Later, we have explored how to use this assay in global mass cervical cancer screening and have described the digital image analysis incorporated in an IT networking system connecting scattered POC with expert Medical Centers to receive fast, accurate and low-cost diagnosis and to enable timely intervention – while the patients is on the premises. [4]

This research and experience were published in two editions of our book, What Every Woman Should Know about Cervical Cancer: (Springer 2008 1st Edition, and 2017 2d Edition). [5]

In summary, we have emphasized the role of screening outreach among the women at risk, the opportunity for self-sampling using the new tools, and a new composite biomarker, MEDYKO. This new term represents a combination of letters, ME (metabolic), DY (dysplasia) and KO (koilocytes - HPV disease); altogether, instantly visible under the microscope and amenable for digital imaging and sharing around the world. Details available on www.bioscicon.com [4, 5]

Our new question “Quo Vadis Pap test?” to the interested audience of the Internet readers is whether, using this opportunity, the healthcare providers around the globe could change the strategy for fighting cervical cancer epidemics, and start using the outcome related strategy to Reverse Mortality of the disease in a predicted period of time? This could be the next step in cervical cancer screening.

FIG. 1 MEDYKO a composite biomarker

Fig. 1. MarkPap® MEDYKO positive assay. A single cell selected under microscope magnification x40 from the specimen prepared by ThinPrep Processor from the PreservCyt suspension with HPV positive (HC2) solution and with cellular dysplasia combined with koilocytosis. MarkPap Research kit staining.  Cervical acid phosphatase isoenzyme is presented by maroon red granules scattered inside the cytoplasm. All three markers indicate LSIL+ diagnosis

List of References:

  1. Markovic O, and Markovic N. Can Acid Phosphatase Reduce Pap Test False-negative Readings? Vol.8, No. 19, October 1, 1997; Correspondence p. 1459
  2. Markovic O, Markovic N, BioSciCon’s Cervical Study Group. Cervical Acid Phosphatase: A Biomarker of Cervical Dysplasia and Potential Surrogate Endpoint for Colposcopy. Disease Markers 2003/2004;19(6):279-286.
  3. Markovic N, Markovic O, Henderson E, BioSciCon’s Cervical Study Group. MarkPap®) Test for Cervical Cancer Screening. J Clin Oncol 2005;23, 165: 1021.
  4. www.bioscicocon.com assessed January 28, 2018.
  5. Markovic N, Markovic O. What Every Woman Should Know about Cervical Cancer. 2d Edition. Springer, 2017. http://www.springer.com/biomed/cancer/book/978-1-4020-6936-9

February 2017

The Unmet Needs

Cervical cancer is still the leading cause of women's deaths from malignant diseases worldwide. Every year about 600,000 women get cervical cancer and 300,000 die. There are 1.7 billion women at risk in the world, but only 10%, at average, get cervical cancer screening protection.

In developed countries women are much better protected from cervical cancer with regular Pap test screening. For example, 50 million Pap tests are performed each year in the US, a cancer control measure that has dramatically reduced the mortality from this disease. However, there are still 20% women at risk in the US who do not participate. This Global Academy for Women's Health has conducted a survey to assess the reasons why these American women do not get cervical cancer protection although (according to the survey) more than 95% of them are aware of Pap test and have real opportunity to get screening. The most frequent reasons for avoiding the testing were being uncomfortable with the pelvic exam, the cost of the test, and having a stressful time while waiting for the results. However, 95% of women agreed that if some more acceptable variant of Pap test could be introduced, like self-sampling, they would gladly have screening regularly.

The situation is quite different in developing countries. There are still objective barriers for world-wide mass cervical cancer screening, namely cost of the test, lack of infrastructure to perform Pap test the Point-of-Care, no access for testing, fear of testing, lack of knowledge about cervical cancer and the possibility to prevent it (Pap test), uncomfortable pelvic exam and various cultural/religious restrains to visit gynecologist. As a result, in these areas only less than 10% women at risk are protected with some cancer prevention measures. These numbers are changing recently, but most of deaths from cervical cancer are still registered in the low-resource areas of the world. The figure 50% outreach for screening must be achieved in order to have a significant decrease in morbidity and mortality from this preventable disease. Apparently, further improvements of the Pap test are necessary to make it available and affordable for global cervical cancer screening. The Global Academy for Women’s Health hopes to be able to make such a difference.

Research targeting women’s malignant diseases supported by the academy

As a part of its research activity related to the advancement of women’s health, The Academy is closely following and supporting the BioSciCon’s R&D activity on the development of MarkPap® platform technology for cervical cancer control (www.bioscicon.com).

Cervical cancer is still the leading cause of women's deaths from malignant diseases worldwide. Every year about 600,000 women get cervical cancer and 300,000 die. There are 1.7 billion women at risk in the world, but only 10%, at average, get cervical cancer screening protection.

The Global Academy for Women’s Health is particularly interested for those products which can meet the aforementioned unmet needs. These products include (1) MarkPap Test Kit, (2) MarkPap Telecytopathlogy Service, and (3) MarkPap Specimen Self-Collection Kit.

  • The manual MarkPap® Test Kit™ with accessories, which is low-cost and simple, allows a low-trained person at the Point-of-Care to process the specimen and recognize the suspicious cells in the microscope, highlighted by the red biomarker (1,4).
  • MarkPap® Telecytopathology Service(sm) which allows the same technician to transmit microscopic images of biomarker positive cells to a distant center for expert diagnosis via digital camera or cell phone (5,6,7,9,10). The result can be received within hours, while the woman is still on the premises.
  • MarkPap® Self-Collection Kit™ for woman to take the specimen at home (2, 5). This kit is designed for women who because of different reasons cannot visit a doctor.

All these tools provide means that, in the near future, a women can take her specimen in the privacy of her home, send it to the local doctor’s office or a small lab where the sample can be processed by a low-trained person who can have instant telecytopathology service for final diagnosis. This is how most of the unmet needs are now much more closer to be met, e.g. cost of the test, lack of infrastructure/professionals at the Pint-of-Care, no access for testing, fear of testing, uncomfortable pelvic exam and various cultural/religious restrains to visit gynecologist. Most important of all the outreach for screening could be markedly increased leading to reduction of morbidity and mortality (11), and the disparity of the healthcare around the world (10). This is the difference that the Global Academy is hoping to make.

Currently, the Global Academy is strongly supporting the development of a local IT Telehealth Center in Rockville, MD, that can provide million diagnostic services per year. The blue print for the Center is ready, space secured and personnel trained. The IT Telehealth Center is expecting State funds in 2012 to finish the final phase of preparation for the start. Actually, the Telehealth Center is expected to be beneficial for the local economy, in-sourcing revenues from abroad, bringing new taxes, building a new infrastructure to stay, retaining jobs and creating new jobs.

Global academy supporting education as an equally important tool for the success of the cervical cancer prevention

In order to succeed, every technology must be accompanied by education. The Global Academy for Women’s Health, Inc. is promoting education of women as the most affordable tool against cervical cancer. The true education is based on facts and the ability to separate reality from wishful thinking. Better education on cervical cancer is a general, still unmet need. Insufficient understanding of this disease may cause unexpected problems - as spreading secondary epidemics. The permanent education is necessary for everybody, even for educators themselves.

Cervical cancer is still the leading cause of women's deaths from malignant diseases worldwide. Every year about 600,000 women get cervical cancer and 300,000 die. There are 1.7 billion women at risk in the world, but only 10%, at average, get cervical cancer screening protection.

In the field of education, the Academy is dedicated to develop high quality professional and public educational programs, organizing and conducting public forums and discussion groups, presenting lectures and workshops, publishing educational and scientific material (brochures and scientific papers), and writing health educational books for general audiences world-wide. Important part is conducting surveys to access public opinion on crucial and controversial issues of women’s health. Surveys could also serve as a tool for validation of the educational program success.

In 2008, Drs. Olivera and Nenad Markovic authored the book "'What every woman should know about cervical cancer", published by an international renown publisher, Springer the book is widely available worldwide as hard cover, paperback, electronic and kindle edition. (Springer.com), or Amazon.com. New, as well as used book can be bought. If you visit those web sites, you will have a chance to read sections of the book directly on the Internet.

This book, providing scientifically proven and medically correct facts should be one of these educational tools that can help women to make their own decision on this and similar dilemmas they may have about cervical cancer prevention, control diagnosis and treatment.. The book summarizes the current views of cervical cancer prevention, control, diagnosis and treatment, presenting them in a language understandable for general public. It is aimed to bring to the readers the rationale for optimism and to provide guidance as how to gain knowledge and skills for critical thinking and making an educated decision when it will be necessary in their lives.

The book is intended to educate the general population of women about true and false information on cervical cancer, HPV infection and vaccines, responsible sexual behavior, other sexually transmitted diseases, cervical cancer detection methods, and the advantages and disadvantages of diagnostic and therapeutic methods as well as holistic medicine available to women worldwide. The purpose of this book is to improve education and reduce risk factors, to improve the awareness of cancer control measures and to improve the outreach of women participating in screening. Its purpose is also to reduce fear of unavoidable death in women who face failure of preventive measures, get cancer and have to fight against the progress of this disease.

However, this book also teaches women about reproductive system and its function, how to increase their level of wellness across all the six dimensions of health, about strategies for stress release applied in health and disease, emphasizing the humane side the fears and despair when women get “bad” results, and where to search for help; precisely, the book is intended to stimulate women to learn more and to actively participate in their treatment--to become advocates of their own health. Authors believe that this book will become a women's companion to turn to when they are motivated to increase their wellness and become healthier, as well as when they are frightened and insecure to learn more and need to diffuse the fear. "Knowledge is power", says one contributor in the "Real People Real Stories" section of this book; she is suggesting that women must learn more to control better their lives. If you wish to read a comprehensive review on this book, please visit Springer’s or Amazon’s web sites, where the book is displayed and offered.

In 2017,  the Second, revised, updated and extended edition of the book "What Every Woman Should Know about Cervical Cancer" was published by Springer. The book is available for purchase here.

The Global Academy for Women's Health is planning to open an interactive page on this web site to enable readers of the book to exchange their thoughts, experience and questions. We would appreciate to hear from you whether such a page will be welcome. Please write to us via the e-mail address provided on the contact page.