Big Advances in Breast Cancer Screening Creating Sizable Opportunities

Palm Beach, FL – February 19, 2020 – While we should all be diligent in cancer detection and treatment in every month of the year, February is well known as National Cancer Prevention Month.  It’s an annual campaign to increase awareness of the disease, which has led to 12.7 million cases globally every year.  That number,  says the Cancer Network, is expected to grow to 26 million by 2030.  One of the most common is breast cancer, which impacts more than 245,000 American women every year, adds the Centers for Disease Control and Prevention (CDC).  More than 40,000 women die from it each year as well.  In an effort to help with screenings, some states like Pennsylvania just passed Senate Bill 595, which requires insurers to cover breast MRI and ultrasounds for women at high risk. “Lawmakers behind the bill say the legislation is a significant step forward in recognizing breast density as an increased risk factor,” reports Local21 News.  “Lawmakers add that dense breast tissue makes it harder to detect tumors, so further screening using ultrasound or an MRI is generally needed.” Some of the top companies leading the fight for better cancer detection include Izotropic Corporation (CSE:IZO)(OTCPK:IZOZF), Hologic Inc. (NASDAQ:HOLX), Athenex Inc. (NASDAQ:ATNX), Seattle Genetics Inc. (NASDAQ:SGEN), and Clovis Oncology Inc. (NASDAQ:CLVS).


Izotropic Corporation (CSE:IZO)(OTCPK:IZOZF) BREAKING NEWS: Izotropic Corporation announced that a notice of allowance has been received from the United States Patent and Trademark office (“USPTO”) for the patent application No. 15/669829, entitled “Measuring Breast Density Using Breast Computed Tomography”. This notice of allowance is the final step before the patent is formally issued.  This patent covers the use of Izotropic Corporation’s dedicated Breast CT Imaging System to measure breast density. Breast CT demonstrates greater accuracy than mammography, the current gold standard for cancer screening and measuring for breast density. This is an important development in the Company’s strategic plan which is expected to provide another competitive advantage and significantly impact both the adoption and use of the Company’s technology in a real-world setting. Dr. John Boone, Principal Founder and Director, elaborates below. In February 2019, the U.S. Congress ordered the FDA to “establish a national minimum standard to include breast density information in mammography reports”, which would standardize the explanations of “the effect of breast density in masking the presence of breast cancer on a mammogram” in the reports received by patients after mammography imaging tests. More than 30 U.S. states now require personal breast density reporting. According to the National Cancer Institute (NCI), nearly half of all women age 40 and older who get mammograms are found to have dense breasts. Dense breast tissue appears white on a mammogram- so do suspicious lesions and tumors. The density of the tissue as well as the compression required for mammography and tomosynthesis breast imaging could obscure abnormalities that may otherwise be further investigated if they were observed using these imaging modalities in non-dense breast tissue. Currently, only a mammogram can diagnose and confirm breast density. Dense breast tissue cannot be felt on a clinical or self-breast exam.


“Breast density is important for two reasons (1) women with denser breasts are thought to have a higher risk of breast cancer, and (2) breast cancer is harder to detect using 2D mammography in women with dense breasts. In the world of health care where “personalized medicine” is now a widely accepted priority, an accurate assessment of breast density then sets the stage for designing each individual woman’s breast cancer screening protocol. Historically, breast density is judged subjectively on two-dimensional mammograms by the interpreting radiologist using a four-point scale. We have shown that the truly 3D volume data sets that are produced using breast CT result in more accurate quantitative estimates of breast density, and this approach significantly outperforms mammography. Therefore, Breast CT may play an important role in quantifying breast density as a woman enters her breast cancer screening years,” says Dr. John Boone, Principal and Founder.  “We have also shown using realistic and comprehensive computer simulations that breast CT, owing to its three- dimensional nature, suffers far less in detection probability than two-dimensional mammography in women with dense breasts. Hence, breast CT or the more expensive and time-consuming breast MRI, are likely to be better screening and diagnostic tools in women with dense breasts than 2D mammography.”


The Company will continue to file and prosecute key patents as an integral part of commercializing Breast CT. This welcome development comes weeks after the Company received a notice of allowance from the USPTO for patent application No. 11/913494, entitled “Biopsy Systems for Breast Computed Tomography.” A system based on this intellectual property would give physicians the ability to image and obtain samples of suspicious lesions and tumors for pathology testing using the Company’s Breast CT Imaging System.


Hologic Inc. (NASDAQ:HOLX) inaugurated its Financial Shared Services Center in Costa Rica, from where it will be providing support for its U.S. and Canadian operations. The center currently has 32 employees with solid experience in accounts receivable and payable and expects to grow this number over time. The Financial Shared Services Center, which kicked off operations in June 2019, is located in the Coyol Free Trade Zone in Alajuela, in the same building where Hologic’s medical device manufacturing plant has been located since 2008. This plant, which manufactures surgical devices for gynecological health and early breast cancer diagnosis, is Hologic’s only plant in Latin America.  The center’s facilities include open spaces for knowledge sharing among employees as well as ergonomic workstations and the latest in technology. It occupies 295 m2 of the company’s 17,187 m2 in the industrial park.  With this expansion, Hologic is consolidating its presence on Costa Rican soil and growing its foreign direct investment (FDI) to attract more human talent.  Costa Rican Minister of Foreign Trade Dyalá Jiménez noted that “the evolution of the medical device sector has gone hand in hand with the growth of the service sector. It is for this reason that today we celebrate the inauguration of a new financial shared services center in Costa Rica that belongs to Hologic. This company confirms its roots in the country, with our people and especially with women, who occupy 62% of the company’s workforce. I take this opportunity to highlight that last year 50% of the 10,141 new jobs generated by FDI companies were filled by the female sector, which fills us with deep pride. We will continue working and hope to continue growing to generate better conditions for all citizens of our country”.


Athenex Inc. (NASDAQ:ATNX) announced that it will release fourth quarter and full year 2019 financial results on Thursday, February 27, 2020, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss the financial results and provide a business update. To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13698005.


Seattle Genetics Inc. (NASDAQ:SGEN) announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s New Drug Application (NDA) for the investigational medicine tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The filing is based on the results of HER2CLIMB, a randomized pivotal trial comparing tucatinib added to trastuzumab and capecitabine versus trastuzumab and capecitabine alone. HER2CLIMB trial results were recently presented at the 2019 San Antonio Breast Cancer Symposium and published in the New England Journal of Medicine(NEJM). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of August 20, 2020. Tucatinib is an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2. “The FDA’s filing of the tucatinib NDA marks an important step forward for patients with locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are working collaboratively with the FDA throughout the review process to bring this important medicine to patients as quickly as possible.”


Clovis Oncology Inc. (NASDAQ:CLVS) will announce its fourth quarter and full year 2019 financial results on Monday, February 24, 2020, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.


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