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16 December 2011, Melbourne: HealthLinx Limited (ASX:HTX) expects to finalise patient recruitment for its second multi-centre, multi-national OvPlex™ biomarker trial by the end of the first quarter 2012 due to excellent interim results from parts one and two of the trial already analysed. Data analysed to date are derived from a sample set comprising 222 women with malignant epithelial ovarian cancer, 53 women with confirmed borderline ovarian tumours, 223 women with benign gynecological conditions and 244 apparently healthy controls. HealthLinx previously announced that preliminary statistical analysis indicated increased diagnostic performance of the OvPlex™ multimarker test compared with the use of CA125 alone and that the increased diagnostic efficiency was apparent for all patients groups within the sample cohort (See Table below).
| ? |
CA125 Correct/Total |
OvPlex™ Correct/Total |
OvPlex™ Advantage (%)
|
|
Normal Control
|
239 / 244 (97.9%) |
239 / 244 (97.9%) |
-
|
|
Benign |
181 / 223 (81.2%) |
192 / 223 (86.1%) |
4.9
|
|
Borderline |
22 / 53 (41.5%) |
26 / 53 (49.1%) |
7.6
|
|
All Malignant |
173 / 222 (77.9%) |
184 / 222 (82.9%) |
5.0
|
|
Early Stage (I-II) Malignant
|
44 / 69 (63.8%) |
48 / 69 (69.6%) |
5.8
|
|
Late Stage (III-IV) Malignant
|
109 / 120 (90.8%) |
110 / 120 (91.7%) |
0.9
|
Additional independent analysis by Emphron Informatics Pty Ltd has now been performed to compare the performance of the OvPlex™ diagnostic to CA125 in terms of overall diagnostic power (as assessed by McNemar’s test). The overall diagnostic power of the OvPlex™ test compared with CA125 was significantly better (p values ranging from 0.035 to 0.003) over a wide range of threshold values. This new analysis highlights the overall enhanced diagnostic efficiency of the OvPlex™ multimarker test over CA125 alone at this interim stage of the trial and suggests that the data should be strengthened further once the full complement of samples is analysed. This type of analysis will be required to establish final measures of sensitivity and specificity and to establish a clinically meaningful threshold once the full sample set is collected and analysed. "This interim analysis is very encouraging and shows a significant advantage of the multimarker test over CA125 alone for correctly classifying a broad range of patients presenting with benign, borderline tumours and early stage malignant tumours. The McNemar’s analysis focuses only on discordant results between the two tests and so it is very pleasing to see a positive result in this interim sample set. The larger sample size at completion of the trial should only enhance this type of analysis" said HealthLinx Chief Scientific Officer Dr Dominic Autelitano. The extremely positive findings, at this point of the trial, have allowed the company to identify a final date to end patient recruitment and will be ahead of schedule. The company will seek to close recruitment of patients from all locations including: the Mater Health Services in Queensland; South Essex Cancer Network United Kingdom; and Liverpool Hospital and its network in the United Kingdom. Following the receipt of the final patient samples, Healthlinx expects to conclude assay of these samples by the end of May 2012 and to finalise the initial analysis of these data by the end of the third quarter 2012. Upon completing the full analysis of these data HealthLinx will undertake an implementation strategy of rolling out a superior performing OvPlex™ algorithm by the end of the third quarter 2012 or early fourth quarter. "The company could see no reason to extend the study beyond it the current collection regime as the results have been exceptional" HealthLinx managing director Nick Gatsios explained. "The focus of the company will be to obtain regulatory approvals in key markets such as the United States, China and South Korea. Any additional studies will be to satisfy regulatory requirements in respective jurisdictions" The company will now proceed with submitting the data to a peer-reviewed journal for publication as well as using these data to aid in regulatory processes for the United States and other key markets.
