A simple blood test could bring another dimension of information to breast cancer detection.
For women whose breast imaging leaves questions unanswered, a blood test that shares biological signals could help clarify the next step in care. Elizabeth Cormier-May, CEO of Mammogen, Inc. and Partner at IV BioHoldings (IVBH), is advancing that possibility, with a particular focus on women with dense breast tissue, who represent nearly half of women undergoing mammography.
Her path to breast cancer diagnostics began as a medicinal chemist at 22. Moving from the laboratory to the commercial side of healthcare taught her how to translate promising science into businesses capable of reaching patients. After years of building companies for others, Cormier-May, a YPO member, wanted to apply that experience to her own entrepreneurial endeavor.
— Elizabeth Cormier-May, CEO of Mammogen, Inc., Partner at IV BioHoldings share
She and her business partner, Martin Keiser, III, have built IV BioHoldings around diagnostics and earlier disease detection. Their work reflects Cormier-May’s conviction that advances in treatment need equally meaningful advances in diagnosis.
“Therapeutics are absolutely essential, but we will never, ever be able to unlock all of their potential without diagnostics,” she says.
That’s at the heart of Mammogen. Its genTRU-breast™ test is designed to detect RNA signals associated with breast cancer, including early-stage disease, through a blood draw. With compelling data already in hand, the company is advancing the test through prospective clinical validation, the final clinical validation step before commercialization.
The gift of time
Mammograms remain central to breast cancer screening. But for the nearly half of women who have dense breasts, dense tissue can obscure cancer in an image. An inconclusive finding can also leave physicians and patients facing difficult questions about further imaging or biopsy.
Cormier-May sees genTRU-breast as a way to bring biological information alongside what imaging can reveal. Intended to complement mammography, the test is being studied in women with dense breasts, who have other factors that elevate their risk, and those whose findings warrant further investigation. Women with dense breasts represent the largest population Mammogen aims to serve.
For Cormier-May, the promise extends beyond detecting disease. It is about giving a woman “the gift of time and a little bit of a sense of control in a journey that she never deserved to be on.”
Timely information could help a woman participate more fully in conversations with her physicians and prepare for decisions about her care. For younger women, those conversations may include fertility preservation before treatment begins.
Listening before building
Cormier-May knew that laboratory results alone could not tell her what women needed from a test, or from the experience surrounding it. Over the past five years, she has spoken with more than a thousand women, including breast cancer survivors, thrivers and previvors, individuals with an elevated cancer risk, as well as family members affected by the disease.
Listening to these women has been one of the most important parts of her work, giving their experiences a direct role in how the company approaches development.
Those conversations challenged one of her early assumptions. She thought women would prefer a saliva-based test to a blood draw. Their responses pointed in a different direction, shaping how Mammogen approached product development.
— Elizabeth Cormier-May, CEO of Mammogen, Inc., Partner at IV BioHoldings share
Those conversations also brought the demands of the current detection pathway into focus. Obtaining additional information often requires further imaging and, when indicated, biopsy, introducing clinical questions alongside challenges of access and coordination. Women may have to navigate multiple physicians, appointments, facilities and procedures, adding logistical burdens to a process that can already be emotionally taxing, physically demanding and expensive.
Cormier-May knows some of that uncertainty personally. She has extremely dense breasts, and has experienced how disjointed, expensive and stressful the pathway can feel.
Financing the next step
Completing clinical validation and preparing for commercialization require capital as well as scientific and clinical expertise. Securing that capital has been one of Cormier-May’s most demanding responsibilities, particularly in a field some investors still approach with discomfort.
“Do you know how many times I’ve walked into a room, and I just say the word ‘breast,’ and you can see the discomfort in the investor’s eyes?” she asks. “It still feels like a private thing.”
She believes women need greater representation on both sides of the investment table, as investors deploying capital and as founders raising it to build companies. That representation must extend to corporate boards, where funding and growth priorities take shape.
In June, Mammogen announced a Series A financing of up to USD30 million to support its prospective clinical trial and preparations for commercialization. “Institutional financing is absolutely necessary once you get to this point,” Cormier-May says.
The financing supports completion of prospective validation and preparations to bring genTRU-breast into patient care. Leading that transition requires the breadth of expertise, and willingness to challenge assumptions, that Cormier-May has made central to building the company.
An early mentor’s advice continues to guide Cormier-May: If you are the smartest person in the room, you’re in the wrong room.
“Particularly in healthcare, there are so many different moving pieces, and if you do not surround yourself with a team that is smarter, better, more passionate, more urgent than you, you will not get to the finish line,” she says.
Her YPO Forum offers another source of perspective: a place to speak candidly with peers who understand the weight of leadership. “I can say things that I can’t say anywhere else, whether it’s fear or excitement or something that just happened,” she says. “It’s a completely trusted and safe place.”
Cormier-May, that responsibility is personal. She cannot promise her 10-year-old daughter that she will never develop breast cancer. She is working toward a future in which her daughter’s generation, and women everywhere, have additional information to navigate breast care with greater clarity and confidence, and more time to make the decisions that matter.
