In collaboration with Yale, feminine panty liner designed to remove obstacles to early detection
NEW HAVEN, CT, (March 28th, 2018) - Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced today the filing of a provisional patent for its innovative medical device candidate intended to address the challenge of early detection of gynecological cancers, including ovarian, cervical, endometrial and uterine.
Internally named “Juno” (after the Roman goddess of fertility) and developed by Precipio’s R&D team in collaboration with Dr. Gil Mor, Yale University Professor of Obstetrics and Gynecology, Juno is a proprietary panty liner device that, in internal testing, we believe has successfully demonstrated the ability to collect and preserve cells from vaginal discharge, potentially enabling the identification of abnormal cells that may indicate the presence of cancer.
The panty liner, worn overnight, is designed to collect vaginal discharge and to be sent to a laboratory where cellular and genomic analysis could be conducted on the collected cells to identify malignancies.
Obstacles to Early Gynecological Cancer Detection
Gynecological cancers or malignancies related to the female reproductive system, including ovarian, endometrial and uterine cancers, can be difficult to diagnose at an early stage1.
Early detection of gynecological cancers is difficult partly due to their non-specific symptoms, as well as the lack of specific and sensitive early detection markers which can make screening tests practically impossible. As a result, these cancers are often discovered at a later stage, significantly reducing the chance of successful treatment2.
Currently, methods available to identify such malignancies include invasive surgical biopsies and imaging techniques such as ultrasound, CT-scan and MRI. For those patients undergoing treatment, or in post-treatment remission, it is crucial to monitor disease remission or recurrence and existing monitoring methods are invasive and seldom used.
Juno’s Disruptive Solution
Vaginal discharge has long been known to include cells with hormones and cytokines that provide clinical insight into inflammation and infection3. We believe malignant cells are shed from the female reproductive tract and discharged through vaginal secretions.
Juno is the first of its kind product - a non-invasive, patient self-administered collection device that we believe can capture and preserve cells in the vaginal discharge – intended to enable identification of malignancies using cellular and genomic analyses.
There are an estimated 100,000 new cases of gynecologic cancers4 (including ovarian, cervical, endometrial, and uterine cancers) in the US alone, and approximately 30,000 will die from the disease5; worldwide these numbers may be tenfold or more.
An estimated 70% of women in the US over the age of 18, or approximately 80 million women, underwent a PAP-test in the past 3 years6, a test intended to screen for cervical cancer. The 5-year survival rate for patients with stage 0 cervical cancer is about 93%; for patients with stage 4 cancer, the 5-year survival rate drops to about 16%7.
Much of the poor prognosis is due to the failure to detect these cancers early, and the inability to monitor patient progress. For example, patients with epithelial ovarian cancer have a 5 year survival rate of 90% if discovered at stage 1; and only 17% when discovered at stage 4. Currently, almost 80% of ovarian cancer cases are identified at a later stage (stages 3 and 4)8, significantly reducing the chances of successful treatment and resulting in an extremely poor 5 year survival rate.
Juno’s potential to provide early detection may result in patients diagnosed in earlier stages, thereby directly impacting patient survival rates. Equally important, recurrence of cancer in patients already diagnosed and undergoing treatment can be especially aggressive and lethal, emphasizing the role of a simple, non-invasive method of monitoring, in reducing death rates. We believe Juno can further serve as a cost-effective cell collection device to periodically test for recurrence in patients in remission.
“This is a ground-breaking product with the potential to materially change the way we diagnose, manage and treat gynecologic cancers”, said Dr. Mor, Professor at the Department of Obstetrics Gynecology and Reproductive Sciences at Yale School of Medicine, and a member of Precipio’s scientific advisory board. “I’m excited to expand our collaboration with Precipio’s R&D team, to bring this important product to commercialization in the battle against gynecological cancers.”
In order to further Juno’s development and commercialization, Precipio is evaluating various options including strategic partnerships with companies that have manufacturing and retail distribution infrastructure.
Regulatory Pathway - Lowest Risk Category
As a non-invasive specimen collection device, we will need to review the U.S. Food and Drug Administration (FDA) applicable classification regulations to determine the least burdensome regulatory pathway for this non-invasive specimen collection device. The FDA regulates microbiology specimen collection devices and menstrual pads as Class 1 medical devices, the lowest risk category of regulated devices, typically exempt from premarket review.
For novel devices, FDA has mechanisms in place for identifying the appropriate regulatory pathway and the company plans to examine the available regulatory classifications and pathways more carefully to help inform additional product development and testing activities.
Precipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine and Harvard's Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.
Certain statements in this press release constitute “forward-looking statements,” within the meaning of federal securities laws, including statements related to ICP technology, including financial projections related thereto and potential market opportunity, plans and prospects and other statements containing the words “anticipate,” “intend,” “may,” “plan,” “predict,” “will,” “would,” “could,” “should,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the known risks, uncertainties and other factors described in the Company’s definitive proxy statement filed on May 12, 2017, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, the Company’s prior filings and from time to time in the Company’s subsequent filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. All information in this press release is as of the date of the release and the Company does not undertake any duty to update this information, including any forward-looking statements, unless required by law.