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European Team Publishes Molecular Endometrial Cancer Test; Startup Sola Dx Plans Fall Launch


NEW YORK – A European team led by researchers at the University of Innsbruck in Austria has developed a new, noninvasive test for detecting endometrial cancer and detailed its creation and validation in a new study published recently in the Journal of Clinical Oncology.

Called WID-qEC, the test relies on a quantitative PCR-based approach to diagnose endometrial cancer in women presenting with symptoms of the disease.

According to Chiara Herzog, a postdoctoral research fellow at the University of Innsbruck and first author on the study, the IP associated with the technology has already been licensed to Sola Diagnostics, based an hour west of Innsbruck in Zams, Austria. Sola is planning a German and Austrian launch of the WID-qEC test for later this fall, and will enter other European markets throughout the course of 2023. The company is also interested in collaborating with North American partners to eventually make the test more widely available, she said.

Founded in 2020, Sola Diagnostics specializes in using epigenetic markers to predict the risk of developing gynecological cancers. Martin Widschwendter, a professor in women's cancer at University College London and corresponding author on the new paper, is a founder. UCL owns the IP associated with the test and licensed it to Sola, Herzog confirmed. A variety of institutions around Europe also contributed to the study and to the development of WID-qEC.

Widschwendter has for seven years led the "female cancer prediction using cervical omics to individualize screening and prevention," or FORECEE project, a European effort supported with €8 million (about $8 million) in Horizon 2020 funding to develop a four-cancer screening test for predicting a patient's risk for developing breast, womb, ovarian, and cervical cancers. The work led to the development of the women's cancer risk identification (WID) platform, and assays for predicting risk for breast (WID-BC) and ovarian cancer (WID-OC), which were described in two Nature Communications papers in February.

Like WID-BC and WID-OC, the WID-qEC test can be run on samples obtained via a cervical swab, similar to the sample collection in a Papanicolaou test, more commonly referred to as a Pap smear. Samples collected from patients are analyzed for methylation markers that the researchers have identified as being cancer predictive.

According to Herzog, rather than using biopsy tissue, the WID approach relies on hormone-sensitive epithelial cells that are used as a surrogate for the tissue at risk. "Our goal is to utilize DNA methylation analysis in surrogate tissues to predict the risk of cancer and age-related disease," said Herzog. "As DNA methylation is tissue-specific, the surrogate sample needs to mirror the epigenetic profile of the tissue at risk," she added.

Herzog said that the clinical need to detect women's cancers earlier is "clear," and said that for endometrial cancer in particular, current diagnostic pathways are not well defined, can be subjective, and necessitate referral to a specialist, leading perhaps to unnecessary invasive procedures. As such, she called the WID-qEC test a "central piece of this overarching vision" to use molecular diagnostics to reduce the need for invasive testing.

To develop the test, Herzog and colleagues turned to Illumina's MethylationEPIC array, a common workhorse platform containing about 850,000 sites for the development of epigenetic tests. They used the array to screen cervicovaginal samples from 572 controls and 144 women with endometrial cancer recruited through the 4C study, and selected markers that evaluate DNA methylation in regions of the genes GYPC and ZSCAN12.

Though costs are falling for whole-genome bisulfite sequencing, Herzog said the Illumina chip "remains the most cost-effective and high-throughput tool for epigenetic discovery," especially when looking at hundreds of samples. "Costs as well as hands-on time would have been prohibitively high for this alternative method," she said. She added that array data has a "smaller footprint," rendering downstream analysis less computationally expensive.

However, they transferred their findings to a methylation-specific PCR approach called MethyLight, which she said allows for the detection of methylation in three gene regions based on fluorescence signals. According to Herzog, the reactions are currently run on a Thermo Fisher Scientific QuantStudio Real-Time PCR System, but most real-time PCR systems can run the test.

As outlined in the paper, they validated the resulting test in 562 cervicovaginal samples collected via cervical smear, self-collection, and vaginal swab. They also looked at different kinds of patients: those presenting with postmenopausal bleeding, some with Lynch syndrome considered to be at high risk of developing the disease, and a control cohort.

The test's sensitivity depending on the sample type was 97 percent for cervical smear samples, 90 percent for self-collected samples, and 100 percent for vaginal swabs. Specificity was 76 percent, 87 percent, and 89 percent, respectively.

The test also identified 91 percent of endometrial cancer cases in samples predating diagnosis of up to a year. Performance was similar across menopausal status, age, stage, grade, ethnicity, and histology, the authors wrote. They concluded that WID-qEC is a "noninvasive reliable test for triage of women with symptoms suggestive of endometrial cancers." Noting the ability to run the test on self-collected samples, they said it could improve early diagnosis and reduce the need for in-person visits too.

Peter Kayatz is the managing director of Sola Diagnostics. He said the 2-year-old company recently closed a business angel financing round worth €1.5 million, and confirmed that it is gearing up to roll out the WID-qEC test, possibly under another name, within the next few months. He added that it will be made available as a laboratory-developed test at first, in part because of the new European In Vitro Diagnostic Regulation, the lagging implementation of which has slowed the path to market for molecular diagnostics firms seeking compliance for their kits.

According to Kayatz, commercialization plans for the WID-BC and WID-OC tests are less clear, with the company currently predicting a launch by the end of 2023. One reason for this is that WID-qEC diagnoses whether or not a person has endometrial cancer, while the other assays predict whether or not a patient will develop cancer within a few years. "This is a very different question," Kayatz said.

He also noted that WID-qEC will be intended for symptomatic women, such as those experiencing postmenopausal bleeding. In such cases, around 10 percent of symptomatic women have cancer. The test also relies on PCR, which will facilitate its launch, Kayatz said. "We have managed to use fewer [markers] for the endometrial cancer test," he said. "That makes it easier and cheaper to perform."

The breast cancer and ovarian cancer risk prediction tests will require instead the use of the Illumina array, plus additional validation. As such, it will take a bit more time before they are available commercially, he said. Kayatz said that Sola has partnered with a collaborative laboratory that has the quality assurances in place to offer such in-house assays under the new regulation. He declined to name the partner at this time.

North America is also on Sola's radar. Kayatz said the company is seeking partners in the US and Canada to make its diagnostics available as LDTs, preferably a lab covering a wide territory and with an existing presence in the gynecological market.