Innovations in Cervical Cancer Diagnostics

Frost & Sullivan’s health care analysts have found international efforts to develop innovative technologies that will identify cervical cancer earlier, faster, and more accurately than existing testing to improve outcomes. Read about some of the best-in-class cervical cancer diagnostic technologies.

According to the American Cancer Society (ACS), cervical cancer was once a leading cause of death among American women. The mortality rate dropped significantly with the wider use of the pap smear test that identifies changes in the cervix so that the disease can be detected earlier and treated more successfully. However, over the last 15 years, the numbers stabilized as pap smear testing reached the limits of its accuracy. Women in general may be reluctant to undergo testing and wait out analysis times. As a result, cervical cancer continues to be a threat to women as they reach middle age and even beyond. The ACS reports that more than 15% of cases are diagnosed in women over 65 years old. The organization projects that 13,240 new cases of invasive cervical cancer will be diagnosed in 2018, causing about 4,170 deaths.

Frost & Sullivan’s health care analysts have found international efforts to develop innovative technologies that will identify cervical cancer earlier, faster, and more accurately than existing testing to improve outcomes. Following are some of the best-in-class cervical cancer diagnostic technologies. 

Eve Medical Inc. (Ontario, Canada)

The World Health Organization estimated that human papillomavirus (HPV) infection causes 528,000 cases of cervical cancer, resulting in 266,000 deaths, each year around the world. The belief that early HPV diagnosis will reduce cervical cancer is among the reasons that Eve Medical designed its HerSwab at-home diagnostic kit. The tampon-shaped product enables women to easily and more comfortably take their own vaginal sample, place it in a transport bag, and mail it in a prepaid shipping box for analysis by an accredited lab. HerSwab is approved by Health Canada and for use in the European Union; in addition to HPV, the kit is validated for chlamydia and gonorrhea.

Biop Medical (Ramat Gan, Israel)

The wait for conventional pap smear analysis—as long as three weeks, after which further tests still may be required—can be stressful. Biop Medical plans to relieve that stress with point-of-care detection technology that will deliver an immediate diagnosis.

The system is contained in a sterile, disposable cover so it can be safely and comfortably inserted to reach the patient's cervix. An algorithm directs a high-definition, digital colposcope to the center of the cervix, where the colposcope will emit light and receive its reflection. The light reflected by the cervical tissue indicates the location of any cancerous or pre-cancerous lesions. These scans will help oncologists map where to perform biopsies and track the advancement of cancer.

The Israeli start-up presented the diagnostic system at the MEDICA 2017 conference in Düsseldorf, Germany, last November after completing clinical testing at a hospital in Hungary, and is raising a second round of funding to pursue commercialization.

Zilico, Ltd. (Manchester, England)

In a marked departure from other novel cervical cancer diagnostic technologies, Zilico designed ZedScan to be noninvasive. ZedScan achieves this by using patented electrical impedance spectroscopy technology to detect the development of precancerous abnormalities of the cervix, also known as cervical intraepithelial neoplasia (CIN). A physician uses the portable ZedScan handset to take 10 to 12 readings around the patient’s cervix—a procedure that lasts a few minutes. The system uses these readings to detect any CIN in real time so physicians can make better- informed decisions.

The University Hospitals of North Midlands National Health Service Trust in England uses ZedScan to improve the accuracy and speed of diagnosing pre-cancerous conditions of the cervix to both reduce unneeded biopsies of patients free of the disease and to provide earlier warnings for improved outcomes.

In February, Zilico announced that it had secured about $17.8 million in new investments to expand the production of ZedScan, and had signed a deal with the MaxHealth Medicine Group to sell ZedScan in the Chinese market. An increase in cervical cancer diagnoses in that country has made better diagnosis a government priority. Zilico forecasts that it will receive at least $11.3 million from this deal.

CANCER-TECH (European Commission/Ireland)

With more than 16,000 cervical cancer deaths annually in the European Union, the European Commission funded a CANCER-TECH project as part of its Horizon 2020 research and development program. CANCER-TECH was conducted in Ireland to develop a novel screening technology to improve early-stage cervical cancer diagnosis. The Irish team prepared nanoparticles specific for different HPV strains—in particular, strains 16 and 18, which physicians hold responsible for most cervical cancers. They then functionalized the generated nanoparticles with ligands specific for HPV and attached them on a laser-textured, polymer-based platform. By using RNA aptamers, the researchers were able to specifically detect different HPV proteins. The  innovative assay developed by the CANCER-TECH team can be used to enhance the sensitivity and specificity of detecting HPV compared with currently available diagnostic methods.

The Road Ahead

The U.S. Department of Health and Human Services has set forth a series of goals, called Healthy People 2020, intended to reduce new cancer cases and the disabilities, illnesses, and deaths that cancer cause. One Healthy People 2020 goal is to increase the proportion of women aged 21 to 65 who receive cervical cancer screening to 93%. According to the U.S. Centers for Disease Control and Prevention, in 2015 only 69% of women 18 or older had a pap smear in the past three years. Frost & Sullivan believes that faster, less invasive and more comfortable  diagnostic technologies like those profiled here can increase the number of women who receive cervical cancer screening to once again improve outcomes, as the pap smear test did starting in the 1940s.

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