The World Health Organization estimates that about 10% of women and girls of reproductive age worldwide (about 190 million people) suffer from chronic pain due to endometriosis.
However, use a grain of salt to make this estimate – probably too low. The average diagnosis delay in patients with endometriosis is eight years, largely due to the standard method used to diagnose the disease, which is an invasive surgical procedure.
Boston-based biotech startup Heranova Lifesciences is addressing the issue by developing non-invasive blood tests. Just this spring, the company announced LDT verification and the U.S. launch of the product, called Herresolve.
When a woman suffers from endometriosis, tissues that usually grow in the uterus eventually grow outside of it, creating lesions in the peritoneal cavity. This abnormal tissue growth can wrap the ovaries and fallopian tubes and negatively affect nearby organs such as the bladder and intestines. The disease usually causes debilitating pain and is the main driver of female infertility.
The gold standard doctors use to diagnose endometriosis is laparoscopy, followed by histological confirmation. Using this method, the doctor puts the patient under anesthesia and performs a laparoscopy to view the tissue and lesions growing outside the uterus – the doctor then takes a tissue sample to confirm the diagnosis under the microscope.
This test method is invasive and not very fast. Heranova's tests are designed to address these issues by using machine learning to analyze a set of biomarkers in a patient's blood sample to determine whether they have endometriosis.
Farideh Bischoff, chief medical officer at Heranova, said the test was comparable to laparoscopy and then histopathology.
She explained that this means that the Heranova test may potentially replace the diagnostic function of laparoscopy, thereby preserving surgical interventions for treatment purposes only.
The test is designed to shorten diagnosis delays and allow for more active disease management before severe symptoms appear. Bischoff notes that it also offers benefits for women experiencing infertility challenges.
“Women with infertility usually have endometriosis, and surgery is often not the option for these women. [a noninvasive test] This is ideal for patients with IVF
Trying to get pregnant – Don't want to reduce the risk of pregnancy. This is the utility of the test – avoid surgery to maintain fertility. ” she said.
Bisov will be in the process of Heranova hopes to develop non-surgical treatments for endometriosis. She said the startup is in the early stages of starting the process and is now identifying the elements to work with.
In addition to the LDT verification that has been obtained, Heranova is working to ensure that the FDA clears diagnostic tests.
“This is for in vitro diagnosis. Then, in vitro diagnosis will create a kit
It can then be distributed to hospitals around the world, as well as [HerResolve] Get More
Attractive to clinical centers that do so. But we will cover both – which means we will have a testing lab and distribute products that allow clinicians to test in hospitals. ” Bischoff explained.
But Heranova is not looking to be the first non-invasive endometriosis diagnosis to clear the FDA.
For example, HERA Biotech, a San Antonio-based startup, has developed a rapid office test that relies on the etiological genetic links of endometriosis.
Bischoff also highlights French company Ziwig, which is creating saliva-based tests as a competitor.
“They use next-generation sequencing, which increases costs and turnaround time. So their tests can take two to three weeks to analyze and get results,” she said.
She added that in her opinion, Heranova's test stands out more because it can object to histological proof itself, not just visual detection of laparoscopic lesions.
Founded in 2022, Heranova has raised about $13 million in seed funding. Penny Wan, co-founder and chairman of the company, said the startup is currently underway for its Series A series with a target of another $15 million.
Photo: natali_mis, Getty Images
