VolitionRx Begins First Ovarian Cancer Detection Study

Q Dr Micallef, you are the Chief Scientific Officer of VolitionRx; can you tell our readers a little about the company, & its main aims & goals?

VolitionRx is a diagnostics company developing blood-based tests for a variety of cancers and other conditions. We have developed a platform technology, Nucleosomics^®, which is based on the identification and measurement of nucleosomes (DNA-wrapped proteins called histones) in the blood. We have developed approximately 20 assays, each of which identifies a particular nucleosome structure, and by combining those assays into a NuQ^® panel test, we are able to detect a particular disease. Originally, we began by working on a test for colorectal cancer, but we quickly discovered that the technology has applicability in other cancers, as well as in other conditions such as endometriosis. Given this, we are developing our tests for a number of different prevalent cancers, including colorectal, prostate, pancreatic, lung and ovarian.

Q Today we are focusing our interview on a new pilot study that VolitionRx is conducting in partnership with the Singapore General Hospital. Can you tell us a little about the study & its main aims/goals? How did the partnership with Singapore General Hospital come about?

Ovarian cancer is a huge problem in women's health. Known as a ‘silent killer’ because the early stages of the disease rarely exhibit symptoms and growths in the ovary are not palpable as other, for example breast, cancers may be. About 75% of ovarian cancers are not detected until after the disease has spread to the abdomen and more than 50% of patients die within 5 years of diagnosis. The study with Singapore General Hospital will be a pilot study – Singapore General Hospital will provide samples from 40 subjects and we will analyze them to assess the ability of our NuQ tests to detect ovarian cancer. We hope that, given positive results from the pilot study, we will be able to expand into further confirmatory trials in larger numbers of patients.

Q What distinguishes your NuQ tests from other ovarian cancer tests currently available on the market? What are the main advantages of the NuQ tests?

There is currently no test which is reliable enough to screen asymptomatic patients for early-stage ovarian cancer. When symptoms lead doctors to suspect ovarian cancer, it is normally detected with either or both an ELISA blood test which identifies a protein, CA125 or an abdominal or transvaginal ultrasound; sometimes followed by a CT scan. Unfortunately, the CA125 blood test is positive in about half of women with late stage ovarian cancer but rarely positive in early cancer. It is also nonspecific and positive in a wide variety of other conditions. Scans, on the other hand, can be very invasive as well as expensive.

NuQ is an ELISA-based blood test technology and so is cost effective and noninvasive, two major advantages when it comes to screening for early-stage or nonsymptomatic cancer. In addition, currently most hospitals and health practices already have the ELISA technology available so adding our panels would be easily done.

Q Can you explain a little about the theory behind the NuQ tests, & how they work?

Nucleosomes are fragments of chromosomes from dead cancer cells circulating in the blood. The chromosomes, and nucleosomes, of cancer cells have many different structures to those from healthy cells or other cancers. A NuQ test is a ‘panel’ of four to five ELISA assays, each of which targets and measures a particular nucleosome structure. A particular pattern of nucleosome structures is indicative of a particular cancer disease. The panel for each type of cancer will therefore be different. Since the level of all nucleosomes is high in cancer patients, the tests use a very small amount of the patient's blood (less than one drop) and can thus be performed as part of a routine health check with no need for the patient to do anything more than they do currently.

Q What changes in diagnosis & management of ovarian cancer do you hope to see if the pilot results are favorable?

If our pilot study results are favorable, we will go on to do larger confirmatory studies. Assuming the data continues to be positive, we will apply for regulatory approvals for the test. We hope to be able to show (as we have in other cancers) that NuQ can detect with significant accuracy cancer at an earlier stage than is currently possible: by detecting the cancer early, the patient can begin treatment earlier, which leads to better outcomes in terms of 5- and 10-year survival rates.

Q I see that you are also in the middle of a prospective study with the University of Oxford to assess the NuQ tests for the diagnosis of endometriosis – what are the main problems with the current diagnostic tests for endometriosis, & how do you hope that your test will overcome these problems?

Endometriosis is a painful and debilitating disease affecting 5–10% of women of reproductive age. It involves a cycle of growth and death of endometrial tissue inside the abdomen with every menstrual period. There is no test for endometriosis, so this monthly cycle of tissue death, and its associated inflammation, continues for years cumulatively and painfully, damaging the woman's reproductive system.

Because there is no test for the detection of endometriosis, women usually present with debilitating pain and/or infertility. In fact, endometriosis is the most common cause of female infertility. Endometriosis is normally diagnosed in these symptomatic women through an extremely invasive laparoscopy (surgical insertion of a camera into a hole cut into the abdomen) to search for endometrial tissue growths. We hope that we can develop a noninvasive blood test for the disease which would diagnose women early and presymptomatically before fertility is damaged.

Q What's next in the pipeline for VolitionRx with regard to matters of women's health? Do you have any other tests in the pipeline that would be of interest to our readers?

We will continue to seek partnerships with institutions interested in endometriosis and ovarian cancer; as well as look to develop our technology for other cancers and conditions, both specific and nonspecific to women.

Q What direction do you see cancer diagnostics in general taking over the next 5–10 years? What are the main obstacles to be overcome?

It is a remarkable time for cancer diagnostics: as we learn more about the genetic and epigenetic basis of cancer, we will be able to apply that knowledge to develop accurate, noninvasive and cost-effective early-stage diagnostics to facilitate early treatment of cancer before it spreads, leading to better patient outcomes. The main obstacle remains the same: namely, that detection of a small early-stage cancer is intrinsically difficult to do, because it is a small body of your own cells which (at early stage) are not disruptive to the body's normal metabolism. Unlike cancer, detection of an infectious disease causing virus or bacteria is relatively easy simply because it is foreign. Similarly, detection of most metabolic diseases is easy through detection of the metabolic failure – for example the elevated glucose levels characteristic of diabetes, but most early cancers do not involve any such disruption to detect.

Disclaimer

The opinions expressed in this interview are those of the interviewees and do not necessarily reflect the views of Future Medicine Ltd.