The Silicon Review
Whether you have been recently diagnosed, are in the middle of follow-up and treatment, or want to increase your odds by early detection, you will certainly know that medical tests and breast cancer go hand in hand. Several reports show that early diagnosis can greatly improve the chance of survival and cure from the disease. A mammogram is still one of the widely used methods to detect cancer early, but the main concern is that the method lacks accuracy, and the radiation from the test is worrying. A breast cancer diagnosis is used to gather more information regarding cancer to give the patient insights on treatment. Globally there are various firms innovating to deliver excellent diagnosis methods for breast cancer, but Mammogen stands out from the rest. Mammogen is the third of three companies operating under the umbrella of a bio innovation studio called IV BioHoldings. Mammogen was incubated with a simple mission: to meaningfully improve every aspect of the women’s health market, and to do so by building a company with an overwhelming presence of women at every level. Less than a year from incorporation, the company is exceptionally proud to report that Mammogen 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 still 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-breastTM 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 unnecessary biopsies, and the corresponding time, cost, risk, and stress related to such procedures. Mammogen’s technology is based on RNA expression, meaning that the genTRUTM platform is getting a 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 tumor 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 our novel and proprietary biomarker discovery platform, uniquely positions the genTRU-breastTM 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 2 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 breastTM 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.
Mammogen is focused on the early detection of disease because early detection allows for two very powerful gifts: time and options. Detection of disease in its earliest stages not only allows for broader and statistically more successful treatment options (both surgical and therapeutic), but it also offers time. Time is exceedingly important for every patient diagnosed, but particularly the younger population of women who need to consider family planning as part of their treatment regimen. Detecting breast cancer early allows for the additional time necessary to consult a reproductive endocrinologist about freezing eggs or discussing fertility after treatment. Sadly, many women don’t have the time to do this upon diagnosis of later-stage disease. Time allows patients to plan for all of the many decisions and changes that follow a diagnosis and women throughout the journey of survivorship. The genTRU-breastTM program will launch in 2023 and is actively engaged in internal R&D discussions related to future genTRUTM products that address unmet needs related to other diseases that affect some-, mostly- or only women. Mammogen’s future will be focused on expanding its women’s health portfolio into indications such as the detection of endometriosis. At the same time, the company will also continue to focus on its commitment to the community. There are multiple exciting things happening with this that will be announced shortly!
Meet the leaders behind the success of Mammogen
Mammogen’s CEO, Elizabeth Cormier-May, has been in the industry for almost 20 years. Starting as a medicinal chemist, she has always had a unique focus on combining science with new market creation. Liz believes that innovation should not be confined to science and platform creation, but that it must include novel ways to include patients and providers throughout every step of development and commercialization.
Mammogen’s Founder, Marty Keiser, created IV BioHoldings after a very successful career in finance. In 2018, after years of investing in biotechnology companies, he set out to redefine healthcare R&D and company creation, in order to speed effective and affordable technologies to patients that can detect disease earlier, diagnose disease easier and treat disease more precisely. Mammogen is one of three companies founded by the IV BioHoldings innovation studio.