TECH-9092
Biomarker-based, Easy and Accurate Pap Smear Test for Low Resource Areas

Acquisition or Licensing Opportunity

Pap smear test is one of the most widely used tests and is given routinely to women in the US during their annual check-ups. This has saved thousands of lives since Pap test was introduced in the early 1940s by Georgios Papanikolaou. Cervical cancer deaths have dropped roughly 80% in the developed countries since 1950s. About 75% of the women of the developed world have been screened recently using Pap test but less than 5% of the women in the developing world are screened. In spite of the progress in screenings, worldwide about 300,000 women will needlessly die this year from cervical cancer. Roughly 83% of these deaths will be from the developing world.

In the USA, roughly 4,000 women will die this year from cervical cancer, about half of which did not have a recent Pap test and a third of them had taken the Pap test but their cancers were missed by the test. Unfortunately, Pap test has changed very little in the last 70 years and is not as sensitive as one would like. It can produce false negatives anywhere between 13 and 45% of the time. To its credit however, this test is fairly specific about detecting cancer and typically produces only about 6% false positives. It is important to have relatively low false positives, because these can create a great deal of anxiety amongst the patients and subject them to unnecessary additional tests and treatments. A large part of the problem is in interpretation of the slides. In conventional Pap tests, you need experienced cytotechnogists, typically persons who have at least a bachelor's degree and two years of specialized training to interpret the slides, and even then this is part art and part science.

So there is a strong need and a huge opportunity for a better screening test which is more sensitive than the current Pap test (without producing a large number of false positives), and is easier and quicker to perform. Ideally such tests should lend themselves to automation or can be done in facilities without highly trained cytotechnologists. Such a test can be ideal for developing markets. Whereas In USA, about 55 to 60 million Pap tests are done every year, in all of the developing countries however, only 20 million Pap tests are done annually. This means that only 1.2% of the at-risk population of 1.7 billion receive a Pap test. So the right technology at the right price can really make a significant difference in the developing nations.

Enhanced Pap Test: Lower Cost, Better Sensitivity and Accuracy, Same Protocol

cells_biomarkerOur client has developed enhanced, patented versions of the Pap test that makes reading and interpreting these tests very quick and easy. By introducing patented reagents to the conventional Pap test kit, it can be simply substituted in place of the conventional test.

The technology behind this new test is a novel biomarker that enhances the visibility of abnormal cancer cells. This makes the interpretation of the test very easy for even a lay person. With this new technology, a person with minimal training will be able to accurately read the pap smear results  because the cancer cells “light” up as red stains on top of the usual blue stains of the conventional Pap tests. And the test is integrated with telemetry via simple smart phone app, allowing the diagnosis of positive samples to be done from central facilities located far away from the clinic.

The new Pap test technology has been tested in over 2,000 women in multi-center, independent clinical lab studies in USA and abroad. Several researchers in India have also tested this test with very favorable findings.

Test Features

a. Higher accuracy (higher sensitivity and less false negative)
b. False negatives below 5% (comparable to the newer HPV tests) 
c. False positives comparable to the conventional Pap test (about 6%)
d. Faster screening
e. Less expensive
f. Better controlled (since the test comes with standard control slides)
g. Easily adaptable to the current testing protocol because the new test merely adds a few additional components to the current pap stains

New Markets with Self-sampling - Doctor's Office / Clinics, Home Testing, Low Resource Areas

microscopeDigital Pap Test with Telecytopathy and Self-Sample versions of the test, open two new avenues for Pap testing - Physician's Office Market and Home Market. This is possible because of the unique biomarker-based technology behind these tests. No other company offers these options in the marketplace today. The digital version will nearly completely automate the interpretation of the results and will be capable of nearly real-time results from the test and Self Test version will allow a woman (by herself or with the help of a health-care worker) to comfortably obtain a cervico-vaginal fluid sample from a swab-like device in the privacy of her home. The technology can also be extended in future to have a rapid home test, such as a pregnancy type of test, since the biomarker is present in cervico-vaginal fluid and would work with a ELISA-type of technology..

global networkMoreover, the Digital version with remote, nearly automated testing, for the first time, will allow developing countries to have access to a high performance, affordable cervical cancer screening test without the need for the extensive infrastructure and skilled personnel that they sorely lack. Cervical Cancer even today claims over 310,000 lives annually - a majority of these are in the developing countries, and 70,000 per year in India itself. In India alone, over 300 million women are at risk - for a disease which is entirely preventable. This technology is the only low cost method that allows minimally trained people to conduct an accurate and humane test.

Competing Products

HPV Testing

Recently, new HPV tests are sometimes being hailed as replacement for the conventional Pap tests. These tests have a fairly high sensitivity (about 5% false negatives). While they are certainly a welcome addition in the arsenal to fight cervical cancers, these tests are both expensive and also give a large number of false positives (can be as high as 25%). This is because among sexually active women under the age of 30, as many as 30-40% of women may show presence of HPV viruses but only 1% of those will actually develop cancer. In rest of the HPV-positive women, the HPV virus usually just goes away on its own without causing any harm. The HPV tests are also much more expensive (roughly 25-40% higher than Pap tests).

According to FDA, CDC and CMS, in spite of recent developments (HPV testing and HPV vaccines) the cytological screening provided by Pap tests, remains the best strategy for prevention of this disease. This is especially true since in the developing countries where even Pap tests are not routinely done, HPV testing and vaccines will be cost-prohibitive.

Visual Acetic Acid Testing (VIA)

This has become a popular alternative to reach low resource population, and has helped. However, it has a serious drawback - it is not as specific, leading to unnecessary and sometimes poorly performed on-the-spot and painful procedures, and is subjective. In other words, it is a poor substitute for Pap Smear test, and no woman who is well-to-do would choose this over pap smear test. According to an article on www.measureevaluation.org, "Although VIA reveals pre-tumors with more accuracy than a typical Pap smear, it also has more false positives. Because VIA-positive lesions are not unique to precancer, a considerable proportion of women will be unnecessarily treated for precancer or referred for further management, which can overload the service site where treatment is being offered (AACP, 2004). ...VIA is subjective because the outcome depends on the clinician’s interpretation of what is seen on the cervix. Also, it is not an appropriate screening method for post-menopausal women. "

Case for the Enhanced Pap Test

This enhanced test makes significant improvements in the current Pap test (sensitivity, simplicity and cost) while preserving the specificity (and hence fewer false positives), and familiarity of the original Pap test. Not only can this test improve the diagnosis of cervical cancers in the developed world, but it can significantly improve the diagnosis in the developing counties by making testing easier and less expensive.

Given the fact that this technology makes it easy to do a better pap test for poorer population, don't they deserve to get the same care as the richer population?

Next Steps

Our client’s company is founded and headed by a team world-renowned cancer research scientist and an oncologist, both of whom are eager to get this technology into the markets worldwide so that many lives can be saved. They are open to sale or licensing of this technology for different regions of the world.

Contact Us

Company is looking to license or sell this technology to buyers or partners in developing countries including India.

Do contact us for more information on this technology and to connect with our client (mention Tech-9092.