Human welfare is significantly impacted by biotechnology. By applying innovation to healthcare the market has brought numerous solutions across varying diseases to patients all over the globe.

Biotechnology often focuses on genetic and genomic information, using patients’ biology to answer diagnostic questions, make treatment decisions, and stratify risk.

Meet Mammogen: A female-led biotechnology firm that uses data, technology, research, and first-hand knowledge to disrupt complacency. The goal of Mammogen is to significantly advance disease detection, diagnosis, and treatment for women around the globe. While they are advancing their flagship early detection breast cancer program, Mammogen is also focused on building a community of resources for patients at all stages of their breast health journey.

Let’s further understand what Mammogen is all about from Elizabeth Cormier-May, Founder and CEO

Q. How does Mammogen most meaningfully address women’s health issues?

Mammogen brings together data, technology, science, and personal experience in novel ways to unlock true early detection in diagnostics. The company has discovered a series of biomarkers, present in blood and saliva, that contain important information regarding a patient’s biological response to breast cancer. Mammogen’s platform has found a way to decode the messages that a patient’s body sends in the earliest stages of disease, enabling real early detection from a simple blood draw.

While others in the industry focused largely on unlocking early detection by analyzing DNA, Mammogen has purposefully focused on RNA. DNA analysis has largely contributed to later stage patient care decisions, but is not well suited for early disease detection. Information from tumor-derived DNA isn’t detectable until the tumor has lived, disrupted, died and shed, thus making early detection improbable. RNA analysis, however, provides real-time data on the biological response to disease, unlocking detection as early as stage 0. By being able to identify cancer at its earliest stage we’re able to give women a far better chance at a brighter future. True early detection is something that should be available for ALL women.

Q. Brief us about the breakthrough technologies designed by Mammogen to solve unmet clinical needs?

Mammogen is on a mission to improve the early detection, diagnosis, and treatment of women-centered diseases. We’re starting with our genTRU™ suite of breast diagnostics. The two early detection tests within this flagship program are based on 26 mRNA biomarkers. The company’s innovative multi-gene expression signatures translate to non-invasive and painless diagnostics poised to bring regular accurate screening to women who are underserved by current guidelines. The genTRU™ suite of products has been validated on both blood and saliva and offers best-in-class performance. The focus for the remainder of 2023 for Mammogen is to complete the CLIA validation of genTRU™ and speed towards commercialization so that early breast cancer detection is a reality for millions of women.

Earlier this year, the FDA finalized their Mammography Quality Standards Act (MQSA), which requires all imaging centers to notify women of their breast density category. This is significant since mammography in women with the densest breasts is only 30-48% sensitive, meaning these women are at a high risk of developing breast cancer that a mammogram will not detect. This single mandate unlocks an immediate 5 million women, $3.5B market, for genTRU^TM , when applied to early detection for Category D, the most extremely dense-breasted women. When extended to the next most dense-breasted women, Category C, the genTRU suite of diagnostics will serve an additional 20 million women, as they all require screening in addition to mammography.

Ultimately, Mammogen's goal is to offer every woman — regardless of age, background, financial situation, or genetics — a chance at early and safe diagnosis. This could potentially save millions of lives. Nothing we do at Mammogen is traditional; everything is, by design, inventive.

Q. Tell us about Mammogen marketplace? How does it create a tangible bridge between science and community?

Mammogen Marketplace is currently in its infancy, but the grand vision is to create a haven of resources for all patients and their loved ones to find products, tools, support, and information as they navigate their personal journeys. Presently our marketplace is where anyone can go to purchase some cozy, comfy clothing and know that they’re bringing real early detection one step closer to women everywhere, as all proceeds go to support breast cancer product development or other women’s health causes and founders. We’re currently in development to expand our marketplace so that it includes resources for patients, caregivers, loved ones and friends. Mammogen marketplace will encompass everything from a list of questions to ask your physician after you’ve been diagnosed, to what exercises and movements to do post surgery, to what to expect after you’ve been treated and graduated form your care team. Mammogen aims to close all the gaps that are currently present in our care continuum. We want to be there for our patients — for anyone really, who needs a community — before, during and after diagnosis.

Q. What does the road ahead look like for Mammogen? Do you have anything new coming up?

Mammogen is building what will be the first of its kind in this industry… a company that’s not just diagnostics or advocacy, but a comprehensive community where all gaps in care are being addressed. The company is building best-inclasstests for their patients, but it’s also forging first-inindustrypartnerships that address ALL of the patients in their collective communities: previvors, survivors, thrivers, and all those who love them.

Q. What is your final message to CIO Bulletin readers and to your current and future customers and partners?

Mammogen believes that there are better, more compassionate, more scalable, and more affordable ways to build and operate a women’s health company. We are proving that thinking and executing differently can meaningfully impact both purpose and profit, while ultimately serving our most important customer: the patient!

Short bio of Elizabeth  Cormier-May

Elizabeth ‘Liz’ discovered her calling at a young age for improving women’s healthcare. She began her career as a medicinal chemist specializing in the early diagnosis of cancer at the Novartis Institute for BioMedical Research. She eventually left the lab because she felt too far from the patient and wanted to make a real difference in the care continuum. For nearly 20 years, she has been establishing new markets, products and companies, all with the same purpose in mind: to introduce unique options and technology that improves patient experiences and saves lives. She believes the key to unlocking true precision medicine lies at the intersection of diagnostics, life sciences, technology, therapeutics and advocacy.

“Our novel multi-gene expression signature for the non-invasive detection and diagnosis of breast cancer has been extensively validated in blood and saliva testing.”