International Life Sciences Awards 2021

14 GHP / International Life Sciences Awards 2021 , Jul21634 Mammogen is the third of three companies operating under the umbrella of a bio innovation studio called IVBioHoldings. Mammogen is a company incubatedwith a simplemission that has not andwill neverwaiver: tomeaningfully improve every aspect of thewomen’s healthmarket, and to do so by building a companywith an overwhelming presence of women at every level. Best Breast Cancer Detection Technology Company – USA Less than a year from incorporation, Mammogen is exceptionally proud to report that it is female-led, has nearly 50% female representation on its Board of Directors, a female majority across its early base of shareholders, and a thriving and diverse community of survivors, previvors and scientific experts who will stop at nothing to detect earlier, diagnose easier, and treat better, from end-to-never-end. Clinically, Mammogen is starting with early breast cancer detection because this is an area with significant clinical unmet need. Most notably, the company is focusing on the under 40 and over 55 populations, which represent nearly 96 million women in the United States who are not being regularly or reliably screened. Mammogen’s genTRU-breast™ program consists of two initial non-invasive diagnostic tests positioned to correctly rule more women into imaging for further evaluation earlier and also to reduce the number of negative biopsies, and the corresponding time, cost, risk, and stress related to such procedures. Mammogen’s technology is based on RNA expression, meaning that the genTRU™ platform is getting far greater understanding of the patient biology and response to disease, as opposed to other liquid biopsy technologies that are largely focused on tumor-derived biomarkers such as circulating tumour and cell-free DNA. Such approaches struggle to detect disease early because they are capturing genetic information that only results from the dying tumor and often is not present enough in a patient’s biofluids to detect until later stage disease. This, combined with its novel and proprietary biomarker discovery platform, uniquely positions the gen-TRU-breast™ program to detect disease early and accurately. The company’s breast program focuses on the populations of women who are traditionally underserved by mammography. While a wonderful tool for many women, mammography was never designed to serve women under 40 for two very important reasons. Younger women often have dense breasts and a lower prevalence of the disease. Mammography is statistically no better at disease detection than a simple flip of a coin in this group of patients. This is particularly unnerving when combined with the fact that it is this younger group of women whose incidence is on the rise, who are more likely to be diagnosed with an aggressive form of the disease, and who are most likely to recur. Similarly, women 55 and older are only recommended for mammography every other year. Because the incidence of the disease is much higher in this population, physicians are forced to biopsy nearly two million women per year upon a positive mammography finding and inconclusive ultrasound and MRI results. The issue here is that over 80% of these biopsies are negative, putting hundreds of thousands of women through unnecessary mental anguish, preventable pain and risk, and needless healthcare spending. Mammogen believes there is a more efficient way to serve this patient population. As such, the genTRU-breast™ program was born, where Mammogen can easily detect breast cancer from a simple blood draw or saliva sample with sensitivity and specificity significantly greater than current standards of care, regardless of age, history of breast cancer, or genetic predisposition. The diagnostic industry has been focused on disease detection, treatment selection, and recurrence prediction for many years, though mostly in the tissue space. As liquid biopsy diagnostics gained clinical traction in the market, companies and tests have been mostly focused on circulating tumor cells and cell-free DNA, which has made early detection elusive, to even the largest and most well- funded companies. Mammogen’s focus on non-tumor derived RNA expression technology, combined with the unparalleled power of the technology driving its biomarker discovery, has unlocked early disease detection in a highly efficient, accurate and clinically useful manner unseen by the industry to-date. This is a particularly interesting point in time, especially for women’s health. The effects of COVID have yet to be well defined. Entire populations of women went a full year without any preventative care, well visits, or screening. Now, as patients are returning to a more normal healthcare schedule, many have chosen to take advantage of telehealth care, solidified by COVID. As a company with a product in early disease detection, Mammogen needs to consider all of these shifting dynamics. As such, the genTRU-breast™ platform is being clinically validated in both blood and saliva as a simple, low cost, PCR test. This unlocks multiple channels to market for Mammogen, ensuring that any woman who needs genTRU™ services receives timely and affordable care, whether it be in traditional or emerging models. Company: Mammogen, Inc. Contact: Elizabeth Cormier-May Email: [email protected] Website: