Craif (Location: Bunkyo-ku Tokyo, CEO: Ryuichi Onose, hereinafter referred to as “Craif”) will start offering “miSignal™” series, a cancer risk screening test for early stage cancer using urinary microRNA (hereinafter referred to as “miRNA”), from February 2022 through medical institutions. 

■ Outline of “miSignal™”
miSignal™ is a PCR test that detects urinary miRNA which plays an important role in the onset, progression and metastasis of cancer. Our distinctive technology efficiently captures urinary miRNA and detects the risk of early-stage cancer with high accuracy. The greatest feature of this test is that it is “painless.” By simply submitting your urine to a medical institution, you can easily check your risk of cancer without any burden. The first test from miSignal series will be for ovarian cancer available from February 2022. Along with the progress of R&D, the number of cancer types that miSignal can cover will gradually increase. For more details, please visit our website (http://misignal.jp/).

■ Background of “miSignal™”
The number of new ovarian cancer cases in Japan is 13,049(*1) per year, and the mortality rate (per 100,000 population) is 7.5(*2). Since the ovary is a pelvic organ, there are few noticeable symptoms in the early-stage of ovarian cancer even when the tumor develops and grows. It is also said that almost half of the new cases are already in stage III or IV cancer when  it is first diagnosed (*3). 
Although recent medical advances have improved the treatment outcome, nearly 70% of the patients experience recurrence within 3 years after the initial treatment (*4). Hence, the 5-year survival rate is 46% for stage III, 25.1% for stage IV, and the long-term survival rate is very poor. Though detection of early-stage ovarian cancer is very important to improve the prognosis, a useful screening method has not been established yet.
As mentioned above, regardless of many medical advances made for ovarian cancer drugs and treatment, early detection and treatment is essential to fundamentally improve the prognosis. By developing and providing a painless and  straightforward urinary test useful to detect early-stage cancer, Craif will contribute to improve the prognosis of cancers.

Source: 
(*1) National Cancer Center Cancer Information Service, “Cancer Statistics” FY2018 (National Cancer Registry)
(*2) Cancer Statistics, Cancer Information Service, National Cancer Center (Vital Statistics, Ministry of Health, Labour and Welfare)
(*3) Japan Society of Obstetrics and Gynecology, Gynecologic Oncology Committee Report FY2017 Patient Annual Report
(*4) Ledermann, J. A., et al. “Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. and follow-up.” Annals of oncology 24 (2013)

■ CEO Comments
Shortly after my grandmother passed away from colon cancer in 2017, my grandfather was diagnosed with lung cancer. This experience led me to have a strong interest in the social problems related to oncology, when I founded Craif in 2018. As I have been working hard on R&D since the start of the company, I am very honored to finally launch miSignal.  However, this is only the first page of our journey, and we will continue to devote ourselves to R&D with great ambition. The social problems in oncology are broad and deep. In addition to increasing the number of cancer types miSignal can cover, we will work on providing support for treatment choices and prognosis monitoring.