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Second OvPlex™ trial reports increased diagnostic efficiency. |
12 October 2011, HealthLinx Limited has completed part 2 of its multi-centre, multi-national biomarker trial for the OvPlex™ ovarian cancer diagnostic with results confirming greater diagnostic efficiency than CA125 alone. These results include the samples assayed in part 1 of the study as well as new data just analysed as part 2 of the trial.
Part 2 of the study consisted of an additional 234 samples collected from symptomatic women presenting to specialist clinics in both Australia and the UK.
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Mass screening for ovarian cancer 'not effective'
5 June 2011, Screening all post-menopausal women for ovarian cancer may not reduce deaths from the disease, say researchers.
Almost 40,000 US women were checked annually over a 10-year period, the Journal of the American Medical Association reported.
During the following nine years, the number of ovarian cancer deaths matched those in an untested group of the same size.
Note: OvPlex™ is not a screening test. It is a diagnostic of proven superior accuracy compared to the CA-125 test alone. The OvPlex™ test does however include CA-125 (one of five markers OvPlex™ looks for) and CA-125 is also individually reported in the OvPlex™ result.
Part 1 of HealthLinx multi-national OvPlex™ ovarian cancer diagnostic study delivers exceptional results
OvPlex™ reduces diagnostic errors by 30% over CA125 alone when comparing normal vs malignant ovarian cancer.
30% reduction in diagnostic errors over CA125 alone is maintained when benign conditions are included as part of the control group.
15 February 2011: HealthLinx Limited (ASX: HTX) reported in December 2010 that initial analysis of part 1 of its multi-national ovarian cancer biomarker study confirmed superior diagnostic performance of OvPlex™ over CA125 in all stages of ovarian cancer including early stage disease. These and additional data were reviewed by the HealthLinx Scientific Advisory Committee (SAC) on 7 February 2011.
The company can now report that the current trial data shows that OvPlex™ maintains superior performance over CA125 when patients with benign conditions are included as part of the control group.
Part 1 of Second Study Confirms Superior Efficacy of OvPlex™ Ovarian Cancer Diagnostic
15 December 2010, Melbourne: Diagnostic company HealthLinx Limited (ASX: HTX) reports that initial analysis of part 1 of its multinational ovarian cancer biomarker study confirms a statistically significant increase in diagnostic performance* of OvPlex™ over CA125 alone. Enhanced performance of OvPlex™ was also established specifically for early stage (Stage I-II) disease.
These data represent preliminary statistical comparisons of area under the curve (AUC) of receiver operator curves (ROC) generated from Part 1 of the second larger multi-national, multi-centre biomarker study. Biomarker measurements in over 500 samples have been completed to date, which represents a subset of the full OvPlex™ study that will include a total of 1150 samples which will be collected in Australia, Singapore and the United Kingdom.
HealthLinx’ OvPlex™ ovarian cancer diagnostic awarded BioSpectrum Asia Product of the Year
5 February 2010, Melbourne: Medical diagnostics company HealthLinx Limited (ASX:HTX) has been awarded the BioSpectrum Asia Product of the Year award 2010 for its ovarian cancer diagnostic OvPlex™. The award was judged by an independent jury of international life sciences experts compiled by BioSpectrum Asia, one of the largest industry magazines in the Asian Pacific region.
The jury judged OvPlex™, along with the Shancol cholera vaccine, as joint winners of the award for 2010. The jury of six included life sciences veteran and leading industry analyst and financier Dr G Steven Burrill of Burrill and Co, Industrial Technology Research Institute vice-president Dr Chungcheng Liu and BioSpectrum Asia chief editor Mr Abraham E Mathew.
Major International Study Begins on OvPlex™ Test
15 June 2010, Melbourne: Melbourne biotechnology company HealthLinx (ASX:HTX) will today launch a major international trial on the OvPlex™ test, that will see 1150 samples screened using the current five (5) biomarker panels and an additional two (2) biomarkers including the recently described biomarker AGR2.
The multi-site, multi-centre trial that is partially funded with $750,000 from the Victorian Government Victoria's Science Agenda Investment Fund, aims to test whether the two new biomarkers can increase the sensitivity and specificity of OvPlex™ to greater than 97 per cent. The study has been powered to allow direct determination of sensitivity and specificity and will include collaborators form Australia, Singapore and the United Kingdom.
OvPlex™ in the news:
Breaking the silence of ovarian cancer
3 May 2011 - Scotsman
The symptoms of ovarian cancer are so difficult to spot that it's called the silent killer. But Fiona Downie, who saw her mother die from the disease, has become one of the first women in Scotland to take a new blood test which could lead to early diagnosis and help save many lives.
We Test The Health Tests - Ovarian Cancer
19 Oct 2010 - Daily Mail (Print)
In their regular Good Health section feature called "We test the tests", this Tuesday the Daily Mail review OvPlex™ - our ovarian cancer diagnostic test.
The Daily Mail write: "The test measures levels of five proteins in the blood, which are present only when ovarian cancer exists. You order and pay for the test from the website. The next day, you will receive by post an OvPlex™ Test Wallet."
Check the October 19 issue of the Daily Mail for the full feature.
Ovarian Cancer Check
13 Sep 2010 - Daily Record
The Daily Record lists a number of tests that people use to avoid getting ill later. Although technically speaking OvPlex™ can not be called a screening tests, the Daily Record goes on to explain that "this new OvPlex blood test can detect ovarian cancer at an early stage. It's a cancer often diagnosed too late, with only 40 per cent living beyond five years." In Scotland, women with symptoms of Ovarian Cancer can go to Spire's Murrayfield Hospital in Edinburgh to have their blood taken for the OvPlex™ test.
New Blood Test Offers Hope For Early Detection Of Ovarian Cancer
9 Aug 2010 - Daily Record (Print)
Lisa Adams, features writer at Scotland's best-selling daily paper the Daily Record, wrote an article about OvPlex™ quoting Dr Cameron Martin, cancer specialist at Spire Murrayfield hospital in Edinburgh:
Dr Martin said: "Ovarian cancer is the most fatal gynaecological cancer. If we can detect it at an earlier stage, patients have a far better outlook."
Check the August 9 issue of the Daily Record for the full article.
Ovarian Cancer - New Commercial Early Stage Test
29 Jun 2010 - ITV News
Filmed at Spire Bushy near Watford by ITN, this ITV News item discusses charity campaigners lobbying MPs for better diagnosis and treatment of this most fatal of cancers. At 1:44 in the short video, Joanne Maunder can be seen preparing to give blood for the OvPlex early stage diagnostic test.
Also on ITN: Ovarian cancer victims call for earlier diagnosis.
HealthLinx gets backing for cancer test
15 Jun 2010 - Sydney Morning Herald
The Victorian government is backing a multi-million dollar trial into a new test for the early detection of ovarian cancer, called OvPlex, which has been developed in Melbourne by biotechnology company HealthLinx.
The Minister for Innovation Gavin Jennings launched a major international second study into the OvPlex ovarian cancer diagnostic test this morning and he said the trials could potentially change the lives of many women in Victoria and around the world. Read more...
HealthLinx identifies novel ovarian cancer biomarker
10 Feb 2010 - CNET News
Australian diagnostics company HealthLinx Limited, along with researchers at the University of Liverpool, have just gotten word from the journal Clinical Science that their manuscript detailing the identification of a novel biomarker in ovarian cancer patients has been accepted for publication. Read more...
New blood test to detect ovarian cancer could save thousands
25 Aug 2009 - Daily Mail
A blood test that could save thousands of women's lives by detecting ovarian cancer at an early stage is to be launched in Britain. Read more...
OvPlex™ official ASX announcements:
15 Feb 2011 - Ovarian cancer diagnostic study delivers exceptional results
15 Dec 2010 - Part 1 of second study confirms superior efficacy of OvPlex
2 Dec 2010 - HealthLinx signs commercial distribution deal in South Korea
12 Nov 2010 - Excellent early results in large OvPlex ovarian cancer study
3 Sep 2010 - OvPlex launched in Asia
5 Jul 2010 - OvPlex now available from new central London location
15 Jun 2010 - Major International Study Begins on OvPlex Test
24 Feb 2010 - OvPlex sales launch in UK on 25 February 2010
17 Feb 2010 - Samples secured for commencement of major OvPlex study
11 Feb 2010 - OvPlex diagnostic clinical trial receives UK ethics approval
10 Feb 2010 - Clinical Science to publish manuscript on HTX005 biomarker
See published article here. (Subscription may be required)
05 Feb 2010 - OvPlex awarded BioSpectrum Asia Product of the year
22 Jan 2010 - HealthLinx expands collaboration with Liverpool University
For more information on HealthLinx Ltd, the company that developed OvPlex™, visit the Australian Stock Exchange and enter the search code 'HTX' .
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