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Vermillion Developing Two New LDTs with Aim of Early Ovarian Cancer Detection

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NEW YORK (GenomeWeb) – Having recently rebranded itself as a "bio-analytical solutions company," Vermillion is seeking to move beyond proteomics and incorporate other sources of data into its test offerings with the ultimate aim of developing diagnostics for the early detection of ovarian cancer in high-risk populations, CEO Valerie Palmieri told GenomeWeb this week.

To this end, the company, through its wholly owned subsidiary Aspira Labs, is in the process of building two new laboratory-developed tests, one combining its second-generation proteomic ovarian cancer test OVA2 with patient ultrasound results and the second combining OVA2 with data from a patient symptom registry the company is developing.

With both tests, the company hopes to move its offerings to earlier points in the ovarian care pathway as it works toward its goal of a diagnostic for early detection.

Vermillion first revealed its new strategy in November of last year when it announced that it was through Aspira developing a series of LDTs called OVAx and that it aimed to launch new tests in the OVAx series every two to two-and-a-half years — roughly half the time it took to launch OVA1 and OVA2.

Vermillion's OVA1 test is currently indicated and cleared by the US Food and Drug Administration for determining if patient adnexal masses are likely malignant or benign, allowing patients with likely malignant masses to be passed on to gynecologic oncologists for surgery while patients with likely benign masses can have surgery done by their gynecologist.

The company has struggled to drive uptake of OVA1, with sales of the test plateauing at around 17,000 per year, leaving the company well short of profitability based on its historic spending patterns.

One issue some physicians have raised regarding OVA1 is its poor specificity, which could lead gynecologists to unnecessarily refer their patients to specialists for surgery. Vermillion is addressing this issue in its second-generation ovarian cancer test OVA2, which it submitted to FDA for 510(k) clearance in March and plans to launch in the third quarter of this year.

The OVA2 test replaces two of the five protein markers in OVA1 with new markers and offers improved specificity and positive predictive value, the company has said. Upon its launch later this year, OVA2 will replace OVA1 and, Palmieri said, Vermillion is currently using OVA2 as the base for its LDT development efforts.

OVA2 has the same intended use as OVA1, as a test to triage patients identified as having adnexal masses. But, Palmieri said, results of studies by the company and its collaborators suggest that the test could be useful upstream of this point in the clinical process.

"We are going to be putting our test in disease paradigms in terms of care pathways where it will be used upstream [of its current use], and the first [LDT] product will be launched in Q3 2016," she said.

Currently, the company is working on an LDT combining OVA2 with patient ultrasounds and another combining the test with data from a clinical symptoms registry it is building.

The ultrasound LDT, Palmieri noted, builds on proof-of-principal work published in the American Journal of Obstetrics and Gynecology in 2014. In that study, researchers looked at 1,024 women who had ovarian imaging, OVA1 analysis, and surgery for an adnexal mass, and found that combining ultrasound and OVA1 significantly improved specificity compared to either test done separately, though at the cost of lowered sensitivity.

Vermillion aims to build a new risk assessment score for ovarian cancer using the OVA2-ultrasound combination that would potentially allow the test to be used earlier in the patient management process.

"Ultrasound is usually the first tool in the toolbox that's used in pelvic mass and ovarian cancer diagnosis, so we'd like to see OVA2 used with ultrasound upfront before the decision to go to surgery," Palmieri said.

The combined OVA2-symptom registry LDT the company is developing could potentially move the test earlier in the patient care process given that, as Palmieri noted, the decision to do an ultrasound is usually arrived at based on patient symptoms.

A challenge to early diagnosis of ovarian cancer is the fact that the associated symptoms, such as back pain and bloating, are fairly non-specific. However, Palmieri said, the company is currently conducting a study looking at reported symptoms in ovarian cancer patients and has found that many patients do report symptoms associated with the disease several years prior to their diagnosis.

With this in mind, Vermillion is building a clinical symptom registry that it will combine with OVA2 analysis. Palmieri said she envisioned the registry as a system that would collect patient reports on an annual basis, with patients entering any troublesome symptoms prior to their regular check-up. The company is currently undertaking a clinical trial comparing the outcomes of patients examined with both OVA2 and a symptom index to those examined using OVA2 alone.

Vermillion is also aiming to move beyond ovarian cancer into the larger gynecological disease space. Driving this effort is the company's focus on developing a registry of patients presenting with pelvic masses, which it can use to study treatment pathways and outcomes not only of ovarian cancer patients but also patients with benign diseases like endometriosis and polycystic ovary syndrome.

"We have about 2,500 [patient specimens] and we're adding about 3,000 to that," Palmieri said, adding that the registry was a resource that the company anticipated would draw collaborators from major academic research centers.

"We're starting with ovarian cancer, because that is the needle in the haystack," she said. "And then our goal is to work backwards in terms of developing other disease care pathways."

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