San Antonio startup Hera Biotech announced that it had acquired Swiss company Scailyte in January, bolstering its efforts to produce new non-invasive diagnostic tests for endometriosis.
Endometriosis is a debilitatingly painful and infertility-causing disease where tissue that is similar to the inner lining of the uterus grows outside of the uterus. A conservatively estimated 10% of all reproductive-aged women have the disease, which can be treatable but which currently requires a surgical procedure under general anesthesia to diagnose.
Randal Robinson, the chairman of the UT Health San Antonio’s Department of Obstetrics and Gynecology and an investigator on Hera Biotech’s clinical trials at UT Health San Antonio, described the procedure.
“The gold standard diagnosis for endometriosis is to do a laparoscopy, that’s a surgical procedure where you put a laparoscope into the abdominal cavity and look at the organs, and then you biopsy the tissue and send that to the pathologist to confirm if there’s any endometriosis that’s present there,” he said.
There are several problems with this procedure, according to Hera Biotech CEO Somer Baburek.
“The success of that procedure is highly dependent on the experience of the surgeon, the skill of the surgeon, but also the presentation of the lesion,” she said. “Physicians are hesitant to recommend a surgery for the purposes of diagnosis. We believe that’s the main driver behind the average of eight years it takes most patients to receive their diagnosis in the U.S.”
Baburek said she aims to expand the diagnostic procedures available with a process that looks for certain biomarkers in tissue that can be acquired without surgery.
“We were the only cell-based assay in the world until this company [Scailyte] discovered another set of biomarkers in the same tissue type that we’re in that they also feel are hopeful in diagnosing endometriosis,” Baburek said. “So as it turns out, those biomarkers are about as accurate — just a little better actually — than the surgery, but they don’t require surgery.”
Baburek founded Hera Biotech in 2020 alongside UT Health San Antonio Professors Bruce Nicholson and Nameer Kirma. She said they were the ones who figured out that endometriosis could be diagnosed through these biomarkers.
She said that process is called a single-cell analysis test, which while very effective, may not work everywhere because of technological barriers and cost sensitivity. That’s where Scailyte’s test comes in.
“The difference is that test, while developed on a single-celled platform, has been moved into a much less complex methodology called bulk PCR, something that can be done in almost any lab in the world,” Baburek said.
Robinson said early diagnosis of endometriosis matters a lot for the lives of those with the disease.
“The earlier that you can diagnose it the earlier you can intervene, and potentially impact on patient outcomes for fertility and for pain,” Robinson said. “Diagnosing it earlier and then also doing it in a noninvasive way would be a really important advancement in the field.”
He said endometriosis may be prevalent in as many as 30% of the infertility patient population, and early diagnosis might make infertility easier to avoid.
Baburek said her company is the first to pursue this because the medical establishment has long ignored women’s health issues.
“Women’s health is poorly, poorly, poorly funded,” Baburek said. “And we as a result haven’t applied technologies that are readily available to places like women’s health.
Baburek said the Scailyte test is about 78% sensitive and 91% specific, whereas the Hera Biotech original test is 97% sensitive and 97% specific.
“Not as accurate as the Hera test, but accurate enough and feasible to run in geographies where Hera’s test might struggle with technology limitations,” she said.
The diagnostic process could easily fit into routine doctor’s visits, Baburek said, and reducing the delay of endometriosis diagnoses could save insurers around $180,000 per patient.
Baburek said she hopes the tests receive FDA clearance by 2026 and begin partnering with specialty distributors to get the test out to OB-GYNs around the country.
