The World Health Organization estimates that endometriosis affects roughly 10% of reproductive age women and girls worldwide, which is about 190 million people. This estimate must be taken with a grain of salt, though, because the only method currently used to diagnose the disease is a surgical procedure.
Hera Biotech, a San Antonio-based startup, is on a mission to change that. The company, which was founded in 2020, is working to develop the first non-surgical diagnostic test for endometriosis. Its clinical trial data looks quite promising to investors, too — on October 26, judges crowned Hera the winner of the MedCity News INVEST Digital Health Pitch Perfect contest, favoring it over six other women’s health and femtech startups in the space.
In endometriosis, tissue that typically grows inside a woman’s uterus ends up growing outside of it instead and produces lesions in the peritoneal cavity. This abnormal tissue growth can envelop the ovaries and fallopian tubes, as well as negatively impact nearby organs like the bladder and bowel. The disease often causes debilitating pain and is a key driver of female infertility.
The only method that doctors have to diagnose the disease is to put a patient under anesthesia and perform a laparoscopy to look at the tissue and lesions growing outside her uterus. This limits access to diagnosis for a lot of people and is a huge reason why the average diagnostic delay for endometriosis is eight years, Hera CEO Somer Baburek pointed out.
“And nearly 70% of patients with endometriosis are initially misdiagnosed with something else first. That lends itself to a whole host of problems — medical gaslighting, patients not knowing what’s going on, compromised productivity and women being cut out of promotions because they can’t show up to work when they’re in debilitating pain,” she explained in an interview.
In its effort to create a better diagnostic process, Hera is treating the disease like a cancer. After all, there is unwelcome tissue growing where it shouldn’t be, Baburek noted.
Her company is searching for a causative genetic link to endometriosis. It’s not measuring downstream biomarkers and trying to correlate that back to some sort of diagnosis — rather, the startup is interrogating the very tissue that generates the lesions themselves, Baburek said.
In its genetic screens of endometriosis patients, Hera has identified significant changes in expression profiles that are uniquely linked to the progression of endometriosis. These changes are present in the lining of the endometrium — which means that they’re easy to access nonsurgically via a brush biopsy.
The test Hera is developing, called MetriDx, collects a sample of the patient’s endometrium using a uterine brush biopsy. This procedure is meant to be conducted quickly in an OB/GYN’s office, similar to a pap smear exam, Baburek explained. The test then analyzes the cells that were obtained to diagnose and stage the disease.
“My hope for the future is that by better diagnosing endometriosis and better tracking the progression of it, we can empower drug developers to develop therapeutics that have meaningful intervention for this disease,” she declared.
At present, there is no cure or treatment for endometriosis. Patients often receive pain medication for their symptoms and sometimes undergo surgery to remove endometriosis deposits, but these interventions don’t stop the tissue growth.
There are some companies that are developing drugs to treat the disease, such as Organon and Swiss biotech FimmCyte, but these products aren’t approved yet. These pharmaceutical companies will have a hard time proving to the FDA that their drugs are effective, Baburek said. Drugmakers can prove that their drug modifies or eliminates the disease in animals, but proving that it works in human trials will be much more difficult to pull off.
“The only way to do that right now would be to cut a woman open multiple times during a clinical trial and look to see if you’re reducing the number of lesions or the size of lesions. No one is ever going to do that,” she explained.
If Hera’s test hits the market, drug developers will be able to nonsurgically “take a quantitative picture of the disease” when each patient starts the trial and then at various intervals, Baburek added. Not only would the test enable pharmaceutical companies to hasten their drug development, but it would also make life a bit easier for patients with endometriosis. If endometriosis is caught early, patients can better understand where their pain and discomfort is stemming from and make appropriate lifestyle adjustments.
For example, research shows that estrogen feeds the progression of the disease — if it’s caught early, a patient’s doctor will know to never put them on estrogen-based birth control. Early diagnosis can also help patients get started with pain management tactics like noninflammatory dieting and pelvic health physical therapy instead of spending years wondering what is wrong with their body, Baburek pointed out.
The only other company Baburek knows of that is also developing an endometriosis diagnostic that focuses on the genetic profile of tissue is Idda Health, which is a spinout of Swiss biomarker discovery company Scailyte. This company’s work is in its early stages, and it has yet to publish research showing the gene set it’s focusing on, she said.
Photo: Walter Lim