Hera Biotech acquires endometriosis diagnostic assets from Scailyte

Endometriosis is a highly prevalent and debilitating disease with severe health-economic impact that contributes to a large majority of female infertility cases. Endometriosis can be an extremely painful disorder in which tissue similar to that which normally lines the uterus migrates and grows on other organs outside of the uterus. Currently, the standard of care for diagnosis is a laparoscopic surgery with histopathology of the excised lesions. The surgical nature of diagnosis contributes to the lack of diagnosis and the eight-year average delay until a woman is properly diagnosed.

The groundbreaking research performed by both companies and their academic partners has clearly demonstrated that there are significant changes in the transcriptome profiles of endometrium samples obtained from endometriosis patients compared to samples from control patients. Based on these findings, the two companies have developed complementary biomarkers and assays for the diagnosis of endometriosis, which offer the most direct, highly accurate and non-invasive way to detect this disorder.

The consolidation of the tissue-based biomarkers will accelerate the creation of clinical tools to diagnose and stratify endometriosis patients and will also enable and catalyze the development of endometriosis therapies and the treatment of infertility among other benefits.

First product to be launched in 2024

The clinical work completed by the companies has shown that utilizing tissue-based samples obtained from a non-surgical pipelle, the diagnostic utility of the test will be superior to those developed from liquid biopsy samples that measure secondary markers to correlate to a diagnosis.

The initial product in the combined portfolio was developed using Scailyte’s deep sequencing discovery platform analyzing over 6 billion transcriptomic data points from 169 patients to yield a highly specific and robust diagnostic assay for endometriosis. Hera intends to launch this first product into the US fertility market in late 2024. Hera intends to follow this launch with a second product, based on its proprietary single-cell technology, for the definitive diagnosis and staging of endometriosis in the OB/GYN market, ensuring patients in both markets have access to non-surgical diagnosis.

Scailyte CEO, Dr. Peter Nestorov commented, “We are excited to work with Hera to integrate Scailyte’s endometriosis assets into the Hera pipeline. Through our collaboration with Prof. Michael Mueller from the University of Bern, we have generated the largest single-cell RNAseq datasets from peripheral blood and endometrial tissue. The insights we gained clearly indicate that the tissue-based approach is the only way to capture the complexity and heterogeneity of endometriosis, and therefore tissue-based molecular assays will be the only viable alternative to laparoscopy for a definitive diagnosis and patient stratification.”

“We are delighted that this partnership also affords Hera the opportunity to add Dr. Cinzia Donato to our executive team and Professor Michael Mueller to our scientific advisory board. Dr. Donato and Professor Mueller were the driving forces behind Scailyte’s endometriosis diagnostic program and bring a breadth of scientific and commercial skills to complement Hera’s in-house diagnostic programs. We are excited to announce this partnership in conjunction with our $15M Series A raise, which we are kicking off at the JP Morgan Healthcare conference next week,” said Somer Baburek, CEO Hera Biotech. Hera Biotech was founded in 2020 and is headquartered in San Antonio, Texas.

The two companies expect to execute the transaction by the end of January 2024, once the final due diligence is completed.