Valerie Palmieri of Aspira Women’s Health: 5 Things Everyone Needs to Know About Cancer

An Interview With Savio P. Clemente

Know the symptoms of ovarian cancer — if any of these symptoms persist more than 2 weeks call your physician. Be aware of these symptoms, advocating for yourself including asking for a pelvic ultrasound could save your life. The symptoms include increase in adbdominal size or bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, frequent urination, and weight loss.

Cancer is a horrible and terrifying disease. There is so much great information out there, but sometimes it is very difficult to filter out the noise. What causes cancer? Can it be prevented? How do you detect it? What are the odds of survival today? What are the different forms of cancer? What are the best treatments? And what is the best way to support someone impacted by cancer?

In this interview series called, “5 Things Everyone Needs To Know About Cancer” we are talking to experts about cancer such as oncologists, researchers, and medical directors to address these questions. As a part of this interview series, I had the pleasure of interviewing Valerie Palmieri.

Valerie is the President and CEO of Aspira Women’s Health, a company that is transforming women’s health starting with ovarian cancer. She has decades of experience in health, technology and science and has been with Aspira Women’s Health for five years. During her tenure at Aspira Women’s Health Valerie led the transition of the company to the commercialization of its market-leading products and is now focused on the company’s product expansion pipeline into benign pelvic mass management and endometriosis.

Thank you so much for joining us in this interview series! Before we dive into the main focus of our interview, our readers would love to “get to know you” a bit better. Can you tell us a bit about your childhood backstory?

I came from a modest background and worked hard throughout my education and my career to reach this current role as President and CEO of Aspira Women’s Health. In fact, my first single family home is the one I live in today. My father passed away when I was college age which kept me close to home for college, I care deeply about family including my Mom (88 yrs young), my husband and two daughters who are amazing Millenial women who are rocking this world! So much of my family is centered around women, I think that is part of what makes me so passionate about women’s health, mentoring women and creating solutions to improve the lives of all women.

What or who inspired you to pursue your career? We’d love to hear the story.

One of my role models is Sylvia Earle, she is head of the National Oceanic and Atmospheric Administration (NOAA) and an ocean activist. She was also the first female chief scientist of NOAA and has led a life of advocacy for protecting our oceans and their wildlife. I began my career as a scientist, and I have respect for Sylvia as both being passionate about a cause and working hard to fight for it. I feel the same way about being able to develop companies to bring technologies that can improve patient lives to help as many people as possible.

This is not easy work. What is your primary motivation and drive behind the work that you do?

It is all about the patients. We have a Patient Advisory Board that includes 5 amazing women who have all been affected by ovarian cancer. Many unfortunately were only diagnosed when their disease had progressed to the late stage. Each of their stories are painful and inspirational. Every day I come to work in their honor to eradicate late stage detection of ovarian cancer and create more innovative tools that help women live healthier lives. I also have a passion to ensure the technology reaches the patients, no matter their gender, education, insurance, race, or socioeconomic status. It’s all about getting patients access to the best technology or the best testing available to help ensure equal access and save more lives. I did this earlier in my career with PSA testing for prostate cancer — and I work tirelessly today to do even more for gynecologic diseases — starting with ovarian cancer.

What are some of the most interesting or exciting projects you are working on now? How do you think that might help people?

Aspira’s core mission is to enable early gynecologic disease detection, starting with ovarian cancer. One of our top initiatives is our work to expand access to our proprietary tools through increased insurance coverage. What makes our company unique is that we are not only working to expand access through more traditional / commercial insurances but also expanding access through Medicare and Medicaid. Medicaid coverage is very difficult as you need to gain coverage state by state, rather than landing a National insurance company which can cover multiple states. Sometimes it takes years. The sad part of this is sometimes it is this population who has limited access to great healthcare already and the hurdles to gain medical necessity for new technology are even higher. Our Medicaid coverage success will ensure all women can get access to our proprietary risk assessment tools regardless of their insurance coverage.

Our company has also recently begun work through an increased government affairs strategy — this will help to ensure there is greater funding, policy, and awareness for ovarian cancer. During the month of September 2021, which is ovarian cancer awareness month we held a congressional briefing in which we brought together a dynamic group to speak to members of congress about the need for change in ovarian cancer management. The event was well attended with over 350 attendees nationally.

Lastly, Aspira is fueled by innovative research that drives our future product pipeline. We have several research related partnerships with groups such as Baylor Genetics and the Dana Farber Cancer Institute to conduct research that we hope will lead to products that will help healthcare providers improve the lives of patients in the women’s health space. We are focused on early detection for ovarian cancer as well as other women’s health diseases such as endometriosis.

For the benefit of our readers, why are you an authority on promoting the adoption of innovative diagnostic tools, especially for cancer?

Well, I don’t know if I am an authority… I spent my entire career transferring disruptive cancer technology from academic centers and building it for scale with the support of operations, commercial, and medical teams to build payer, provider and guideline adoption. This “foundry work” is tough and there is not “one recipe” or “one size fits all” to move a technology from zero payer covered lives to the majority in the US. I have spent seven years with Aspira Women’s Health working with some of the top physicians in the US who specialize in women’s health. I’ve led the charge in developing and refining new and better risk assessment tools for ovarian cancer so that we can detect risk and treat disease sooner. We’re making early risk detection possible for women of all ages and ethnicities so that their diagnosis does not have to be so bleak.

Tragically, 1 in 2 women diagnosed with ovarian cancer will die of the disease. My team and I are working tirelessly every day to change that. The current test most often used by healthcare providers to detect ovarian cancer is CA125, although it was never approved by the FDA as a risk assessment tool. It is simply insufficient. In fact, our research has demonstrated that 71% of ovarian cancers missed by CA125 could be identified by OVA1®. OVA1®plus is significantly more sensitive than CA125 at assessing the risk of ovarian cancer, particularly in the early stages.

Ok, thank you for all of that. Let’s now shift to the main focus of our interview. Let’s start with some basic definitions so that we are all on the same page. What is exactly cancer?

Cancer can happen when some of the body’s cells become abnormal and grow uncontrollably and then spread to other parts of the body. Cancer happens when cells that are not normal grow and spread very fast. Normal body cells grow and divide and know to stop growing. Over time, they also die. Unlike these normal cells, cancer cells just continue to grow and divide out of control and don’t die when they’re supposed to. These cells can form tumors, which can be cancerous (malignant) or noncancerous (benign). Cancer cells can form solid tumors but can also cause cancers of the blood ie: leukemias or lymphomas. Depending on the stage in which the tumor is found and whether it is benign or malignant determines the possible courses of treatment and likelihood of survival.

When cancer is detected early, a patient typically has more treatment options and a higher survival rate. For example, with ovarian cancer, if found in stage one there is a 93% 5-year survival rate. If it is found in stage four there is a 27% 5-year survival rate.

What causes cancer?

It is hard to know for sure. What we do know is there are certain things that may make some people more likely to develop cancer. We know genetics and family history can play a role as well as some lifestyle choices, such as smoking.

A woman is at increased risk of developing ovarian cancer if 1 or more of the following applies:

1. AGE — Women over 50 are more likely to develop these cancers.
2. ETHNICITY — Women of North American, Northern European, or Ashkenazi Jewish heritage have an increased risk of ovarian cancer. People of some of these ethnicities also have higher risks of BRCA mutations.
3. FAMILY HISTORY- A strong family history of breast or ovarian/fallopian tube cancer puts women at higher risk for ovarian/fallopian tube cancer.
4. GENETICS — About 10% to 20% of ovarian/fallopian tube cancers occur because a genetic mutation, or change, has been passed down within a family.
5. WEIGHT — Recent studies show that women who were obese in early adulthood, but not those who gain weight later in life, may have an increased risk of developing ovarian/fallopian tube cancer.
6. ENDOMETRIOSIS — May increase the risk of certain types of ovarian cancer, including clear cell and endometrioid ovarian cancers.

What is the difference between the different forms of cancer?

There are more than 100 types of cancer. Types of cancer are usually named for the organs or tissues where the cancers form. For example, lung cancer starts in the lung, and brain cancer starts in the brain. Cancer can affect patients differently based on where in the body it is located or what preexisting conditions the patient has. Also, the variables in each of our own bodies can create different presentations of the same disease.

There are several types of ovarian cancer including:

1. Epithelial cell cancer, the most common type, of ovarian cancer, occurs in the cells that cover the outer surface of the ovaries
2. Germ cell tumors originate in the cells that produce eggs
3. Stromal tumors originate in the structural tissue cells that hold the ovaries together

Unfortunately, the symptoms of ovarian cancer are often vague and are ignored by women and even at times by their healthcare providers. These symptoms are NOT silent but can be easily ignored as some can mimc monthly menstruation and can include, bloating, abdominal or pelvic pain, difficulty eating or feeling full quickly, frequent urination, and sometimes weight loss. Sadly, that’s why ovarian cancer is usually diagnosed at the late stage, when prognosis is quite poor. If a woman experiences these symptoms frequently and for more than two weeks it’s vitally important that she has a serious talk with her doctor.

I know that the next few questions are huge topics, but we’d love to hear your thoughts regardless. How can cancer be prevented?

Cancer prevention starts with an old saying, “you are what you eat”! For ovarian cancer we recommend you live a healthy lifestyle, be aware of the symptoms, understand your genetic risk, be proactive with your doctor, follow up with your doctor and advocate for yourself if symptoms persist. It is important to partner with your doctor on a care plan. In patients with a known genetic risk, surgery to remove ovaries and fallopian tubes prophylactically can be discussed with their doctors. This has been shown to decrease ovarian cancer.

How can one detect the main forms of cancer?

It’s important listening to your own body and talking to your doctor if something doesn’t feel right. And it’s important to have regular check-ins with your doctors and keep the line of communication open. Although there are some screenings and diagnostic tests for cancers such as breast and prostate cancer, there is NOT a screening test available for ovarian cancer today.

Therefore, the tools and test we provide at Aspira Women’s Health are so important. Ovarian cancer is typically discovered at late stage (stages III or IV). If the ultrasound shows that a mass is present, the physician will first determine if the mass should be removed surgically. This is where our test comes in. OVA1®plus is used to assess ovarian cancer risk if a mass is planned for surgery to determine which specialist should perform surgery, a gynecologic oncologist or a gynecologist. OVA1plus uses multiple biomarkers to determine the risk that the mass is high risk for malignancy. This allows doctors and patients to determine the next steps together.

Cancer used to almost be a death sentence, but it seems that it has changed today. What are the odds of surviving cancer today?

Early detection and advanced therapies have improved rates of survival of certain types of cancers, but ovarian cancer is different. It is the only gender specific cancer with over a 50% mortality rate for all women because more than 60% of women are diagnosed at late-stage disease, when prognosis is poor.

Patients are diagnosed late because symptoms are ignored or in many cases a patient is sent to several other specialists not trained at identifying ovarian cancer such as a gastrointestinal doctor, urologist or orthopedic doctor for back pain. In addition, many OBGYNs are still using a 40 year old outdated blood test, CA125, to assess the risk of a pelvic mass prior to surgery. CA125 was intended for recurrence monitoring after a woman is diagnosed with ovarian cancer. In fact, the ACOG guidelines support using a multivariant index assay like OVA1®plus in order to assess risk prior to surgery. We are equal to CA125 in the guidelines.

From your experience, what are a few of the best ways to support a loved one, friend, or colleague who is impacted by cancer?

It is the little things that truly matter when supporting a friend or loved one with a cancer diagnosis. Things like making plans, offering to help, and simply checking in are great ways to show support. Remember to treat them with space and respect. Help them find ways to laugh but also allow them room to feel and say what they need to express. Everyone copes differently and anger and sadness are also key parts of the healing journey. Support them every day regardless of how they are feeling in the moment.

What are a few of the biggest misconceptions and myths out there about fighting cancer that you would like to dispel?

There are two big myths I would like to dispel particular to ovarian cancer.

The first is that a Pap smear can detect ovarian cancer — this is not true. A Pap smear is a screening test for cervical cancer — it is not used to screen for ovarian cancer. Many women don’t know this and think that a negative pap smear means that they’re safe from cervical and ovarian cancer. They are not!

The second is that many physicians and patients think that the CA125 test is the best way to assess risk of ovarian cancer. It was not approved by the FDA for this; it was approved for recurrence monitoring after an ovarian cancer diagnosis. CA125 misses ~ 20% of risk in all ovarian cancers and up to 37% of risk in Black women. OVA1 in conjunction with imaging and clinical assessment is 96% sensitive in detecting ovarian cancer risk. CA125 also performs especially poorly in detecting ovarian cancer risk in early-stage disease, pre-menopausal women and several subtypes of ovarian cancer. OVA1 performs well across these different groups which makes it a much better test for ALL women with pelvic masses planned for surgery.

Thank you so much for all of that. Here is the main question of our interview. Based on your experiences and knowledge, what are your “5 Things Everyone Needs to Know About Cancer? Please share a story or example for each.

1. Know the symptoms of ovarian cancer — if any of these symptoms persist more than 2 weeks call your physician. Be aware of these symptoms, advocating for yourself including asking for a pelvic ultrasound could save your life. The symptoms include increase in adbdominal size or bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, frequent urination, and weight loss.
2. Know your family’s history — does your family have a history of breast, ovarian, or colorectal cancer? Is anyone BRCA-1 or -2 positive? Did you know that 10–15% of ovarian cancer is due to a hereditary genetic cause?
3. CA125 is not effective at assessing risk of ovarian cancer and is particularly ineffective in Black women. CA125 Sensitivity to detect risk in Black women can be as low as 62.5%.
4. There is no screening test for ovarian cancer. A Pap smear does not screen for ovarian cancer, and ovarian masses cannot be biopsied prior to surgery
5. Early detection is the difference between life and death. Aspira Women’s Health’s OVA1®plus performs better than CA125 at detecting risk of ovarian cancer in early-stage disease. OVA1 sensitivity is 91% in early-stage disease while CA125 sensitivity is 63%.

You are a person of great influence. If you could start a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. :-)

I want to start a movement that lessens the disparity Black and non-Caucasian women encounter in their pursuit of healthcare. For example, in ovarian cancer, the 5-year survival rate for Black women is 36% vs 46% for Caucasian women.While much my work is focused on closing the racial equity gap in ovarian cancer risk detection, racial equity is a problem that pervades our entire healthcare system.It is a system designed without the needs of communities of color in mind, thereby jeopardizing the wellbeing of a tremendous part of our population. Our future is diverse, and the success and wellbeing of our country depends on closing the racial equity gap in healthcare. When you take care of women, you take care of humanity, as women “lift” the world in many ways!

How can our readers further follow your work online?

Readers can follow me on LinkedIn or visit us at aspirawh.com and follow Aspira’s social channels on LinkedIN, Instagram or Facebook.

Thank you so much for these insights! This was very inspirational, and we wish you continued success in your great work.