On December 3, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported results from its latest proof of concept study (Press release, VolitionRX, DEC 3, 2019, View Source [SID1234551897]). A single pre-clinical Nu.Q assay utilizing a basic microtiter plate platform detected 80% of newly diagnosed Non-Hodgkins Lymphoma ("NHL") and Leukemia cases (mixture of Acute Lymphocytic Leukemia ("ALL") and Acute Myeloid Leukemia ("AML") at 95% specificity among healthy subjects. The Area Under the Curve ("AUC") for this single assay was 91%. A number of other assays in development also demonstrated promising individual assay results with AUCs ranging from 79% to 91%.
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Commenting on these results Dr. Jake Micallef, Chief Scientific Officer at Volition said, "This is a very exciting outcome as we continue the development of our assays beyond colorectal, lung and prostate cancer. We have previously announced results from both single assay and panels of Nu.Q biomarkers but the results of this discovery study are the best single Nu.Q assay result in any cancer we have demonstrated to date. We are delighted to report such promising results for Nu.Q’s ability to detect a range of blood cancers in this small study.
The objective of this proof of concept study was to investigate a range of cancer conditions not previously studied for detection using Nu.Q assays and the results showed remarkable detection for all 3 blood cancers tested. The next steps are to evaluate these findings in independent larger clinical trials of symptomatic populations using Volition’s automated ELISA product platform whilst we also continue pre-analytics studies".
Dr. Jason Terrell, Chief Medical Officer at Volition said, "This is an important finding for us. These types of hematopoietic malignancies are difficult to diagnose. Symptoms are often vague and non-specific such as fatigue and recurrent infections and yet the definitive diagnostic tools of bone marrow or lymph node biopsy are invasive and can be expensive. There are over 700,000 new cases of NHL, ALL and AML diagnosed globally each year and approximately 415,000 deaths. Whilst clearly more studies need to be conducted, we hope that a routine blood test using our Nu.Q technology could lead to earlier diagnosis."
About the Study
Commercially obtained patient blood plasma samples were taken from 62 healthy volunteers (mean age 45 years) as well as approximately 300 patients previously diagnosed with bladder, bone, brain, esophageal, head and neck, melanoma, skin, uterine, or cervical cancers (mean age 56 years) and 54 subjects diagnosed with hematopoietic cancers (mean age 57 years).