CYduct Diagnostics, Inc. was formed in 2020 when Solos Endoscopy, Inc., a public corporation founded in 2005, and CYduct LLC, which develops personalized breast cancer risk assessment tools to help identify precancerous and cancerous lesions in the mammary duct, merged.
The combined company became CYduct Diagnostics, Inc. CYduct Diagnostics is disrupting the breast cancer market with the first precision medicine test for women, coupled with additional breast health medical devices for the early assessment, identification, diagnosis, and ultimately treatment of breast cancer.
CYduct is committed to providing women and clinicians with non-invasive and minimally invasive technology that will accelerate the ability to: 1) assess breast health risk, 2) monitor breast health, 3) identify the need for increased personalized risk surveillance, and 4) and someday diagnose/treat breast cancer at its earliest stages through direct visual examination within the breast’s ductal system.
There is an unmet clinical need for increased monitoring of breast health, particularly in women already at high-risk and those with dense breast tissue, to detect breast cancer earlier. An alternative approach to the established imaging modalities is required. Nipple Aspirate Fluid (NAF) is a unique liquid biopsy that can be used to assess molecular changes associated with breast cancer progression. The early proteomics testing was time-consuming and expensive. In order to test biomarkers linked to breast cancer, a more efficient method is required for clinical use in larger populations. The aim of CYduct is to develop the tools and processes that offer an effective testing method that could analyze the targeted proteins in NAF that correlated with breast cancer.
Positioning With Current Trends
CYduct Diagnostics will capitalize on several women’s healthcare trends. First, direct-to-consumer (DTC) diagnostic testing is rising in healthcare. CYduct’s B-FIRSTbreast test will let women get breast health risks/screenings without a doctor. Which gives women privacy, convenience, and accessibility.
Second, personalized medicine, also known as precision medicine, tailors additional medical evaluations to each patient. It uses genomics, proteomics, and metabolomics to analyze an individual’s genetic, molecular, biochemical, and environmental aspects to make better decisions.
Last but not least, dense breast tissue increases breast cancer risk. Dense breasts impair mammography readings, increasing risk. Dense breasts affect 40% of women and 50% of mammography patients. Mammography misses over 50% of breast cancer in this demographic. This year, the FDA mandated that all U.S. mammography facilities notify women of their breast density by September 2024.
Proteomic testing, which is helping CYduct understand proteins’ role in disease progression, could change how clinicians and individuals diagnose and assess a wide range of diseases, from breast cancer to Alzheimer’s. Proteomic testing can uncover breast cancer biomarkers early, enabling earlier and more accurate diagnosis.
Transforming Breast Health
Women will be able to evaluate their individual breast health risk thanks to CYduct for the first time. Because breast cancer cells undergo a lengthy molecular development (from precancerous atypia to malignant), there is an urgent need for early diagnosis of breast cancer lesions. Therefore, CYduct will aid in the earliest detection of breast cancer and improve the survival rate of women by empowering them early to take charge of their breast health on a more personalized and precision medicine basis.
Time separates CYduct from its competitors. Early detection is the most important factor in breast cancer survival. There is no breast cancer early detection approach. Doctors, public health campaigns, and cancer organizations have passionately promoted mammography as the “gold standard” breast cancer screening technology for nearly four decades. A vast amount of research demonstrates that the aggressive, widespread use of mammography over the past few decades has had little to no influence on breast cancer mortality rates. Early discovery of breast cancer has a 90% five-year survival probability, while late detection by conventional mammography drops it to a single digit. Breast cancer cells go through a long molecular progression from precancerous through atypia to malignant; thus, early identification is crucial. Thus, early empowerment of women to take charge of their breast cancer risk/screening on a more customized and precision medicine (biomarker) basis will enhance breast cancer diagnosis and survival.
The B-FIRST product test from CYduct is an innovative, patent-pending test for a woman’s breast health risk assessment. It will be able to find high-risk, precancerous biomarkers and is non-invasive. The B-FIRST test uses information generated by the breast ductal cells, which is an image of the microenvironment where approximately 95% of breast tumor cancers are born.
Getting Past the Obstacles
CYduct reviewed a number of breast cancer proteomics studies, and several of them had encouraging findings. For instance, one study indicated that cytological analysis of breast fluid had a sensitivity of 42% and a specificity of 94% for identifying breast cancer. This study was published in the Journal of the National Cancer Institute. They discovered via further research, that there is mounting proof that breast fluid proteomics can be used to predict breast health. The cornerstone of the strategy for overcoming the difficulties in early breast cancer diagnosis is strong clinical evidence demonstrating the use of proteomics in breast fluid with a high predictive value for breast cancer.
Although B-FIRSTCYduct’s risk assessment test, which will be the company’s flagship product, is not yet on the market, CYduct does have some intriguing company experiences. At the recent, renowned Susan Love Foundation for Breast Cancer Research International Symposium on the Human Breast, an occasion devoted to enhancing breast health. The clinical team’s breast cancer risk assessment expertise earned them a coveted grant award. The CYduct team also had an encouraging response from the breast cancer advocates in attendance, who all favor giving women more autonomy over their breast health. This excitement and energy fuel the groundwork for CYduct to accomplish its purpose and put breast health management in the hands of all women. They plan to collaborate with these advocacy organizations as they advance CYduct Diagnostics.
CYduct has two goals for the near future: 1.) to globally launch their MammoView product line of FDA-cleared endoscopic and imaging devices that allow physicians to observe, biopsy, and excise or ablate breast tissue from within the mammary ductal system, where over 95% of breast cancer originates. 2.) Develop and launch the B-FIRSTbreast cancer risk assessment test product, which is expected to be the first personalized breast health risk test that uses proteomic data and personal history measures to assess breast health and allow women to monitor their risk at home. The proteomic B-FIRST test will also boost CYduct’s MammoView product range.
CYduct’s personalized testing process improves breast health and wellness. CYduct will offer the first evidence-based personalized breast health risk assessment testing and follow-up platform. CYduct believes its solutions will revolutionize breast healthcare by bringing precision medicine to early detection and successful therapy.