Studies in the United States and Europe successfully demonstrate the potential of a Parsortix-based blood test to out-perform current tests in diagnosing ovarian cancer, Angle has recently announced. More specifically, the blood test demonstrates potential in discriminating between benign and malignant pelvic masses.
Angle’s European study, ANG-001 (NCT02785731), is being led by Robert Zeillinger, PhD, at the Medical University of Vienna. The U.S. study, ANG-003 (NCT02781272), is being led by Richard Moore, MD, at the University of Rochester Medical Center, Wilmot Cancer Institute.
According to the trials results, a test using the Parsortix system can successfully differentiate between benign and malignant masses with a high degree of sensitivity — up to 95 percent — while also achieving a low false-positive rate (higher specificity) than current options.
The Parsortix system works by taking a blood sample (or liquid biopsy) from a patient. Then, a disposable microscope captures and harvests circulating tumor cells (CTCs) from the sample, based on the cells’ size and compressibility. A third step consists of selecting viable cells for analysis. Once captured and identified, the system reads RNA information within the cells, and informs clinicians about the patient’s condition based on the results, helping to determine the most appropriate treatment.
Advantages of this system include not depending on the use of antibodies, being very sensitive and specific, capturing clinically relevant cancer cells, allowing easy harvest of CTCs, being inexpensive, having very little environmental impactful, and being easy to use.
When researchers compared the Parsortix test with CA125 (a currently available blood test used to detect ovarian cancer) in ANG-003, the Parsortix test had a specificity that nearly doubled that of CA125.
“The 200-patient ANG-003 clinical study shows that the Parsortix test has the ability to accurately discriminate malignant from benign pelvic masses prior to biopsy or surgery. The test also offers key additional benefits over existing practice through the gene expression information it provides, which may help to further guide choices for targeted therapy in women with ovarian cancer,” said Moore in a press release.
Moreover, these results perform better when selected genetic information from patients is combined with the Parsortix test in a specifically developed algorithm. This proprietary algorithm will be further optimized to give the best performance in an upcoming validation study.
Angle’s Parsortix blood test potentially could assist in diagnoses prior to biopsy or surgery, allow patients with a benign tumor to receive care in their communities, and perhaps reduce healthcare costs and avoid unnecessary transfer of patients from their local hospital to specialist referral centers.
“The 200 patient ANG-001 clinical multi-centre study has shown that the Parsortix based test allows us to successfully discriminate patients with ovarian cancer from patients with a non-malignant pelvic mass with a high degree of accuracy. Using ANGLE’s Parsortix system and a panel of RNA markers, there is the prospect that we can meet a key medical need in triaging women before surgery to ensure patients with cancer get the care they need,” added Zeillinger.
A validation study is now planned to meet European CE Mark, a regulatory confirmation that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, and U.S. Food and Drug Administration (FDA) regulatory requirements. Successful completion of these validation evaluations will allow the commercialization of the Parsortix test in the U.S. and Europe and, eventually, worldwide.