healthlinx achieves primary objective

HealthLinx Limited
ABN 88 098 640 352
576 Swan Street Richmond VIC 3121
Telephone: +61 3 9208 4200 I Facsimile: +61 3 9208 4201
www.healthlinx.com.au
HealthLinx achieves primary objective in Second Study of OvPlexTM ovarian cancer diagnostic
2 November 2012, Melbourne: HealthLinx Limited (ASX:HTX) is pleased to announce that it has achieved the primary objective of its Second Clinical Study to statistically validate the diagnostic performance of OvPlex™ in the target patient population. This validation has been achieved using the industry standard statistical test for multimarker diagnostics; the McNemar’s test, and demonstrates that OvPlex™ is superior to CA125 testing in symptomatic women.
The Second Study of OvPlex™ recruited 1007 participants of which 256 were normal controls. The remaining 751 patients were women presenting to their doctor with symptoms that were considered possibly related to ovarian cancer (later diagnosed as having benign conditions, borderline disease or malignant ovarian cancer). Full clinical evaluation of these patients was undertaken and all 1007 participants received an OvPlex™ test and a CA125 test as a part of their disease diagnosis.
OvPlex™ is designed to assist clinicians in the evaluation of symptomatic women to provide a more accurate indication of the likelihood of ovarian cancer when compared with the currently used CA125 test. CA125 is utilised as a minimally invasive blood based diagnostic tool to provide an indication of the likelihood of ovarian cancer in symptomatic women however as CA125 levels can be elevated by a variety of other gynecological conditions, it has a high false positive rate (incorrectly diagnoses patients).
The use of OvPlex™ was compared to CA125 in determining disease status. Independent statistical analysis performed by Emphron Informatics Pty Ltd, using the McNemar’s test, found that OvPlex™ was statistically significantly better (p value of 0.027) than CA125 in overall diagnostic performance in 1007 patients. OvPlex™ correctly diagnosed 862 of the trial participants compared to CA125 that correctly diagnosed 839.
More importantly, OvPlex™ was found to have statistically significantly better specificity than CA125 alone (p value of 0.006), thus, indicating OvPlex™ is more accurate at identifying patients without ovarian cancer. Of the 630 patients found to not have ovarian cancer (controls and benign patients) OvPlex™ incorrectly diagnosed 53 of these as compared to 68 incorrectly diagnosed with CA125. This information may assist clinicians to make more informed decisions regarding the management of women found to have benign conditions.
These results on the final full study data set confirm those previously announced in December 2011. HealthLinx’s Chairman stated “These positive findings on the full data set provide HealthLinx with the final confirmation that OvPlex™ has the potential to offer significant benefits when utilised as a tool to assist in diagnosing women with symptoms indicative of ovarian cancer. The ability to more accurately determine that a woman is unlikely to be suffering from ovarian cancer alleviates emotional concerns for the patient and should assist in decisions regarding their medical management. Previously, HealthLinx announced it has entered into Heads of Agreement to sell the OvPlex™ assets to Mane Cancer Diagnostics, who now with this compelling final study data will be in a position to design and seek Food and Drug Administration approval to conduct trials in the USA to secure product registration in the USA.”