With its lack of early diagnostics and greater than 50% mortality rate, ovarian cancer impacts enormous costs to women and society as a whole. But there is light at the end of the tunnel, thanks to Valerie Palmieri, a force to be reckoned with and the featured guest on this episode of Busine$$ of the V. As President and CEO at Aspira Women’s Health, she is not only overseeing the development of blood-based solutions that will improve gynecologic health outcomes, she is also fighting mightily to ensure that these non-invasive blood based risk assessment tools are available to women across the socio-economic spectrum.

Ovarian cancer is the fifth most common gender-specific cancer and, says Valerie, the most grueling of them all. But Aspira’s FDA-cleared bio-informatics products are able to detect with a high level of accuracy,  the risk for malignancy in pelvic masses – a breakthrough compared with the limited ovarian cancer diagnostics available to date. The company has also recently launched Aspira GenetiXSM testing, which offers both targeted and comprehensive genetic testing options. The trick is to predict personalized risk of this evasive cancer as early as possible.

Valerie shares her journey both personally, as a scientist and executive in the startup diagnostic space, and as a vigorous advocate for equal access to ovarian cancer diagnostics. A formidable leader, she is driving awareness for Aspira, building a niche for the company within the life sciences sector and fighting to save lives (along with enormous private and governmental insurance expense). She offers advice for up-and-coming life sciences entrepreneurs and a glimpse of a future in which genetic markers will play a big role in ensuring women’s health. As Rachel notes after reviewing Aspira’s study results: “The numbers are life-changing!” Enjoy this hopeful conversation with a stand-out femtech pioneer!

HOT FLASH: The American Cancer Society estimates that nearly 20,000 women will receive a new ovarian cancer diagnosis in 2022 while 13,000 will die from the disease.   

TOPICS COVERED:

• Valerie shares her long-established interest in and track record with women’s health, initially as a scientist and ultimately as an executive with life sciences companies.
• With a variety of executive roles under her belt, Valerie has taken companies from zero to hundreds of employees and millions of dollars in revenue.
• Equal access to diagnostics for all (especially under-served women) has been a guiding light and driving force in Valerie’s career.
• Valerie explains Aspira’s mission and evolution, starting as a Department of Defense grant to develop technology to measure pelvic mass risk in the field. DoD remains to this day one of the largest granters of funding for ovarian cancer research.
• Valerie is among those fighting to level the playing field for allocation of resources for ovarian cancer, which is vastly under-funded by comparison with other, less deadly, cancers such as prostate cancer.
• Ovarian cancer is not the most common female-related cancer, but it is the deadliest. Fewer than 50% of diagnosed patients survive, largely because of its late diagnosis.

• Although ovarian cancer has huge personal impacts and societal repercussions, there is not yet an early screening test available.
• Aspira is focused on determining risk for ovarian cancer in pelvic masses and also developing genetic testing for predisposition to the disease.
• Because it’s rare – although not silent, as it’s often erroneously labeled – ovarian cancer symptoms frequently go under the radar – especially because women tend to ignore their own bodies while caring for everyone else around them.
• Among the ovarian cancer symptoms that are murky and often over-looked: gastrointestinal issues, irritable bowel, ovarian cysts or urinary tract issues. It’s also hard to pick up masses during routine gynecological exams until they become quite large.
• Valerie explains that the CA-125 blood test for ovarian cancer risk is not especially accurate, even though it’s considered in parity with Aspira.
• One out of 76 women will get ovarian cancer. At an early stage, CA125 will miss 40-50% of diagnoses where Aspira’s technology catches 90%.
• The role of insurers in making critical testing unaffordable. Aspira technology is currently covered as medically necessary technology for 194 million women. The goal is to increase that coverage to the entire population. If your insurance will not cover Aspira’s diagnostics, they offer an out-of-pocket price of $195 for testing.
• In their quest to make Aspira’s technology available to all women, the company has made it a priority to do the labor-intensive work of enlisting coverage from Medicare and Medicaid in all 50 states.
• The main hurdle to accelerating the deployment of Aspira testing is raising awareness among clinicians and continuing to evolve iterations of the diagnostic tool.
• Sensitivity vs. specificity: The former indicates how well a positive test predicts an actual positive result and specificity refers to how well a negative test predicts negative results.
• One out of two women with ovarian cancer today currently die – the only gender-specific cancer with that kind of mortality rate. On average there are $1 to $2 million in expenses for medical treatment that only 50% of women survive. Early detection is KEY.
• Valerie Shares Advice:
  • There are people you might not think will listen but who in fact want to listen – and help.
  • You may be pushing the rock for a while, but breakthroughs do happen (like the huge leap in governmental support Aspira has experienced in the past six months).
  • Follow your passion and listen to your heart.
  • Incorporate diversity in studies; genetic differences can be enormously illuminating.
• Dr. Dweck reflects on personalized care as being a future standard and the role that genetic markers through blood testing will play.

QUOTES:

(01:10) – “One of the pitfalls with ovarian cancer diagnosis is that many of the symptoms are vague, so they’re often attributed to much more common and less deleterious situations.” (Dr. Dweck)

(05:20) – “In a startup (scientists) have a lot of different opportunities. It’s not like you have to come with a specific skill set.” (Valerie)

(06:30) – “One of things we’ve talked about during Covid is this idea of access to care, which has taken on an even more urgent meaning.   It might have just been distance, but now it’s distance, economics, availability.” (Rachel)

(13:40) – “Could there be a day when we actually take high-risk (ovarian cancer) screening and move it to a-symptomatic or general population screening? That is our hope and that is the Holy Grail!” (Valerie)

(22:01) – “We want to give access to (Aspira diagnostics) for everyone – even those who don’t have access to health insurance.” (Valerie)

(26:24) – “I love the statistics and the fact that you have early detection at 48%. These numbers are life-changing!” (Rachel)

(28:43) – “Doctors will tell you that (ovarian cancer) is one of the most grueling diseases to impact the human body. So it’s not even the (monetary) cost but the fight that these women undergo.” (Valerie)

(33:2) – “If there are new entrepreneurs out there, make sure that you’re looking at diversity and ethnicity so you’re looking at personalized risk … Don’t forget that we’re not homogeneous. That is so, so important.” (Valerie)

BIO:

Valerie was appointed President and Chief Executive Officer in January 2015, prior to joining Aspira Women’s Health as Chief Operating Officer in October 2014. She brings to Aspira Women’s Health more than 30 years of experience in the diagnostic laboratory industry, serving in numerous sales, operations, and executive leadership positions for both laboratory service and consulting organizations. Before joining Aspira Women’s Health, Palmieri was CEO/President of MOMENTUM Consulting. She also served as CEO/President of two healthcare start-ups that resulted in a successful exit for one and won her recognition as one of the “Top 10 Entrepreneurs of Springboard Enterprises” for the other.

FURTHER RESOURCES:

Website: www.aspirawh.com
Valerie’s Profile

Valerie @LinkedIn