FERMISCAN BREAST CANCER TRIAL 69-75% ACCURATE
May 12th 2008 09:31
Friday May 9, 2008
Daily news on ASX-listed biotechnology companies
* ASX UP, BIOTECHS DOWN: PORTLAND UP 24%; CYTOPIA DOWN 10%
* FERMISCAN BREAST CANCER TRIAL 69-75% ACCURATE
* PSIVIDA TRIALS MEDIDUR WITH LUCENTIS FOR AMD
* SIRTEX LEGAL CASE WON, NOW FOR THE COSTS
* HEARTWARE REELECTS DIRECTORS; APPROVES 1.1m CEO SHARES
* AGENIX DIRECTOR DR ANDRE LAMOTTE RESIGNS
* BANK OF EAST ASIA INCREASES TO 19% OF BIODIEM
* ANZ SELLS 2.5m BIOPROSPECT, 62k SOLAGRAN OPES PRIME SHARES
THE MARKET
Eight of the Biotech Daily Top 40 stocks were up, 19 fell, six were unchanged and seven were untraded.
Portland was best, up one cent or 24.39 percent to 5.1 cents on small volumes, followed by Acrux up eight cents or 8.51 percent to $1.02 and Heartware up four cents or 8.0 percent to 54 cents.
Cytopia led the falls down three cents or 9.68 percent to 28 cents followed by Peplin down three cents or 6.0 percent to 47 cents and Benitec down 5.32 percent.
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FERMISCAN
Fermiscan says its 2,000 patient trial of its non-invasive hair x-ray diffraction test for breast cancer is 69 to 75 percent accurate.
This trial was designed to compare results from the current breast cancer screening methods of mammography and ultrasound and any subsequent biopsy and pathology results with the Fermiscan test.
Preliminary results with 800 patients late last year gave the Fermiscan x-ray diffusion method an 82.4 percent accuracy rate compared to 68 percent for mammography (see Biotech Daily; December 20, 2007).
Fermiscan said the trial confirmed the ability of the Fermiscan test to detect the presence of breast cancer, using x-ray diffraction of hair.
The company said accuracy of 69 percent was achieved and by exclusion of patients whose hair was subsequently analyzed and independently confirmed as having been treated and damaged, the accuracy was 75 percent.
The company said its validation phase is now complete.
Fermiscan said that it would progress to commercialization of the test in Australia in 2008.
Fermiscan said the x-ray hair test correctly diagnosis about 1500 women as negative for breast cancer and 20 patients correctly as positive for breast cancer
The company said the test correctly identified as negative for breast cancer 80 per cent of patients referred for a biopsy as a result of mammography, which the company said “highlights the potential value of the test in conjunction with current screening methods”.
The company said 13 patients found to be positive for breast cancer by a mammogram and biopsy were missed by the Fermiscan test.
“This is believed to be due to damage to hair from treatments not identified by fluorescence screening and/or biological variation,” Fermiscan said.
The accuracy of the test can be affected by hair treatments such as perming, dyeing and straightening, which can be overcome in most cases by using new growth of the hair, which the company says takes about four weeks.
Fermiscan said the accuracy of the test in a commercial use was expected to significantly improve as women would prepare for the test by ensuring they have undamaged new growth of hair for testing. During the trial this could not take place as patients had no advance notice of the test and the requirements.
The value of the test for women of all ages was confirmed with patients covering a wider age group than current screening recommendations.
The company said it would optimize synchrotron beam-lines to improve high resolution images, automate improvements to extend commercial capacity, secure access to synchrotron beam lines in key countries and secure medical and patient advocate groups.
Fermiscan managing director David Young said the results “validated the commercial potential of the Fermiscan test”.
“Given its non-invasive nature, suitability for women off all ages and comparative accuracy relative to other screening methods currently available, the commercial potential is significant,” Mr Young said.
Further analysis of the data from the 2,000 patient trial to refine the analysis methodology and criteria to further improve the accuracy of the test.
Commencement in the next few months of approved clinical research with leading hospitals in Italy and Japan as well as the Ashford Cancer Centre, a leading Cancer Clinic in Adelaide.
Fermiscan plans to gather data from patients with a range of breast cancers (and other cancer patients) to allow further refinement and improvement of the test
Fermiscan fell 2.5 cents or 2.67 percent to 91 cents.
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