As a condition often difficult to diagnose, endometriosis patients require updated and non-invasive diagnostics. Aiming to address this unmet need, Heranova continues to develop its lead asset HerResolve.
As the only non-invasive, blood-based test to diagnose endometriosis, the test allows women to avoid the need for exploratory surgery when the disease is not present.
On 27th March, the company announced the completion of Laboratory Developed Test (LDT) validation for HerResolve. Initial launches are planned at selected clinical centers with nationwide expansion set to follow.
This is a timely announcement, coming in Endometriosis Awareness Month (infographic at bottom of page), which aims to raise awareness about this chronic condition.
Speaking to the In Vivo podcast, Bischoff stated that: “Endometriosis is not a malignancy. It does not kill the individual, but it certainly impacts quality of life.”
Historically, the diagnosis of endometriosis may have required a laparoscopy, which with HerResolve is not only an invasive procedure, but now an unnecessary one.
Leading in a scientific area that began her career, Bischoff shared how she has truly experienced a “full circle moment” and suggests that, “What I have gained in the last 30 years is hands-on experience in developing non-invasive tests that really address unmet needs.”
In Vivo spoke with Bischoff about the development of HerResolve and the company’s search for additional funding, as its lead asset is expected to receive possible FDA clearance by the end of the year.
Timestamps:
02:32 Introduction
11:23 How does Heranova differentiate itself from competitors in the women’s health sector?
13:32 Engaging with the scientific community
16:13 Navigating regulatory challenges
19:39 Funding for early access sites
31:23 Looking ahead
