MAMMOGEN, INC. REVOLUTIONIZING EARLY DETECTION DIAGNOSTICS FOR FEMALE HEALTHCARE

With the increasing ‘shentrepreneurs’ around the world, women are crushing the billionaire’s club. Being a woman is challenging, and leading a business is backbreaking. It’s tough juggling the complexities of running a business and raising a family. But it can and has been done. Against all backdrops, they are smashing glass ceilings and making a serious difference in technology, healthcare, education, and other fast-paced industries. In this regard, the dwindling gender gap in biotechnology has aroused interest in recent years. With the mounting numbers, the vertical is becoming more conducive to women than other stem sectors. 

Many of them have devised apparently unsolvable solutions for the environment, medical sector, food industry, healthcare, and pharmaceuticals. In this light, Elizabeth Cormier-May, a dynamic biotech entrepreneur from Connecticut, is reinventing women’s healthcare. In our latest issue, “Innovative Companies of the Year – 2021,” we are pleased to feature her brainchild, Mammogen Inc., for its tech and R&D-based solutions towards care for women, their families, and their loved ones. 

REIMAGINING WOMAN HEALTHCARE

“Never doubt a group of thoughtful and committed citizens can change the world; indeed, it’s the only thing that ever has.” This thought-provoking note of Margaret Mead lays the foundation of Mammogen. Led entirely by women, it is on a mission to improve the detection, diagnosis, and treatment of women’s ailments. 

But what makes Mammogen Inc. distinct in its arena?

It brings together data, technology, science, and personal experience to disrupt the status quo and break complacency. The company is working on developing and commercializing multi-gene expression profiles found in RNA, a polymeric molecule involved in gene coding, decoding, regulation, and expression. These biomarkers are present in every bio-fluid (blood & saliva) and contain important information regarding bodily functions. Understanding the signatures and identifying changes in the RNA enables the early detection of complex diseases like cancer. Although DNA analysis has largely contributed to later stage patient care decisions, it is not well suited for early disease detection. For instance, information from tumor-derived DNA isn’t detectable until the tumor has both lived and died, thus making early detection improbable. RNA analysis, however, provides real-time data on the biological response to disease, unlocking stage 1 detection. 

Mammogen’s innovative multi-gene expression signature is non-invasive and painless, and it’s poised to bring regular, accurate screening to women who are underserved by current medical practices. The technology has the potential to reduce false negatives and increase early screening among women, while also reducing false positives and allowing for the safe monitoring of suspicious nodules. Ultimately, its goal is to offer every woman, regardless of age, background, and financial situation, or genetics, a chance at early and safe diagnosis, potentially saving millions of lives.

ELIZABETH CORMIER-MAY: A RECKONING FORCE OF CHANGE

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 save lives. 

This inherent motivation also led her to Mammogen, where she and her team are creating products to get the right women to the right intervention at the right time. Mammogen is developing the genTRU^TM breast products, two diagnostics based on 26 mRNA biomarkers, to detect breast cancer earlier in women who are not eligible for mammograms, and to rule out women who do not need to undergo breast biopsies. “With sensitivity and specificity in the upper 90%, these products are poised to disrupt breast health in the most impactful way possible,” says Liz. 

Liz and her team are forming a powerful community of survivors, fighters, and previvors. Spending nearly two decades in this space, she understands how female malignancies influence people’s lives and how terrifying they can be for the victims. She strives to bridge the gap between research and support, allowing people to talk about the concerns, anxiety, melancholy, marital difficulties, and body-shaming issues that occur with breast cancer. The team is also forming alliances with other female entrepreneurs focusing on clinical, social, physiological, and mental health issues that accompany the previvor, survivor, and remission journeys.

SOPHISTICATED TO THE LETTER

Mammogen’s uniqueness and strength are built on innovation and technology. It aids in the saving of time, cost, and inefficiency in R&D, resulting in a risk reduction in clinical development and flexibility in market strategy. “We were able to cut the average R&D and analytical validation process by 7 years and save over 95% of the industry average cost,” highlights Liz. 

This shows how Mammogen approaches clinical development and diagnostics with a fresh look and understanding of how it is moving forward towards true precision medicine. Of course, this requires a multidisciplinary strategy that includes diagnostics, imaging, genomics, genetics, targeted medicines, and follow-up care after the “cure” or remission. Liz feels that, for the first time in medical history, multidisciplinary approaches incorporating diagnostics and unlocking early detection bring the industry closer to fully achieving personalized care.

Mammogen is one of three companies that make up IV BioHoldings, a bio innovation studio founded by Martin Keiser. The studio focuses on creating first-in-class RNA bio platform firms that will revolutionize disease detection, diagnosis, and treatment. The firm’s approach to product development, partnership creation, and commercialization unlocks their ability to excel in terms of speed, efficiency, and risk management.

THE DYNAMIC TEAM OF MAMMOGEN

If technology is its heart, the team is the soul of Mammogen. As previously stated, it is a completely female-led community, with everyone believing in and focusing on a cause larger than themselves. This inspires commitment and induces out-of-the-box thinking and problem-solving capabilities. “Nothing we do at Mammogen or IV BioHoldings is traditional; everything is by design inventive,” says Liz. It’s constantly reinventing the industry’s backdrops, rearranging the pieces, and pushing best-in-class products. And it’s always open to welcome new talents. The inherent ingenuity and efficiency complement its team’s effort to go beyond the fence. The very reason, it is constantly seeking people who can keep the company focused on improving patient outcomes and creating meaningful impact.

The team’s consistency and performance describe Liz as a dynamic leader. Throughout her journey, she has been adaptive to the different phases of the company’s growth cycle. And as a leader, she has never stuck to only one philosophy or strategy that she expects to work across the entire business spectrum or all of the team building. “I try to do one thing very well, and that is to help people find where they excel and to pair that with what makes them tick,” she says, “and that’s how you unlock someone’s full potential.” Liz believes that transparency is the real heart of solid leadership. This fundamental quality helps her keep the team focused on the end goal while navigating the highs and lows. The team takes its successes and disappointments in stride, as one unified team. Liz also strives to instill an optimistic and realistic mindset, which keeps the team innovative while they devise strategic and meaningful tactics to achieve new milestones.

UNWAIVERED EVEN BY PANDEMIC

It’s no epiphany COVID-19 has reinforced the need for clinical diagnostics. “I’d also argue that the pandemic has proved beyond a shadow of a doubt that we must be able to detect a disease/condition before we can treat it effectively,” adds Liz. Needless to say, the period throws the spotlight on Mammogen to shine. Since its science is centered on mRNA as a medium and PCR as a technology, the company has experienced significant tailwinds in awareness around how their tests work. While there is still some work to be done before physicians and payers view diagnostics with the same importance as therapeutics, the pandemic has demonstrated that diagnostics are an absolute necessity for quality care beside therapeutic intervention.

While the pandemic caused severe agony across the globe, it also pulled together the entire scientific community to work towards a common goal. Liz believes this is the finest demonstration of total alignment of resources and what can be accomplished with a unified mindset.

CONSTANTLY CREATING BREAKTHROUGHS 

“A significant journey is less important than having a deep impact.”

Mammogen’s principal feature has been its ability to collect paradigm shifting early data. Its biomarkers have best in class sensitivity and specificity across all stages of the disease and within multiple biofluids. Additionally, the time it invests in creating a community that spans the gap between science and survivorship is a major laurel. “Companies rarely put this level of commitment towards non-revenue producing activities, but we believe strongly that we must serve our patients in every way we can!” Liz asserts proudly. “We are confident that our community will unlock our market and our market will fuel our community,” she continues.

With an upbeat ambition, Liz and her team are planning an early detection solution for breast cancer, with portfolio expansion focused on other areas that do not currently have viable solutions. Mammogen also has a defined focus on planning for the inevitable digitization of diagnostics. Clinically, Mammogen aims to expand and lead with expertise in early detection – for both product and IP. On the digital front, Mammogen intends to stay ahead of the curve. With a planned mobile app, Mammogen is awaiting the day when a woman will order her genTRU^TM test from her device or receive her results digitally and participate in the community from her phone. “We are innovating around every piece of a patient’s journey… not just disease detection,” asserts Liz.

FOR PATIENTS AND ASPIRING MINDS 

“Be present in your healthcare journey. Don’t be afraid to ask the tough questions to your care teams or to the industry that is providing your team with the tools they are using. And be vocal, as often as possible, about what you need as a person or patient as you’re navigating any health decision so we, as an industry, can continue to innovate in as many ways as possible to fill as many gaps as possible.” 

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