HEALTHLINX: NEW CANCER MARKER, 2nd TEST ‘98% ACCURATE’
December 11th 2008 01:42
Monday December 8, 2008
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HEALTHLINX
Healthlinx expects its second generation ovarian cancer test using previously undetectable bio-markers to be available within 12 months.
At a media briefing organized by Monsoon Communications, Healthlinx chief executive officer Nick Gatsios said two novel markers for ovarian cancer were introduced to the test and “one identifies tumor types not seen by CA125 [the standard test] at all”.
“That is a very powerful thing to have,” Mr Gatsios said.
“One marker has never been found to circulate in plasma. We have developed an Elisa [enzyme-linked immuno-sorbent assay] with our partners and it is definitely circulating in women’s blood - and we’ve found it,” Mr Gatsios said.
In its media release to the ASX, Healthlinx said it had completed an initial phase II biomarker trial on the second generation ovarian cancer diagnostic that “increased the diagnostic efficiency of the panel to 98 percent for early stage diagnosis”.
“This compares with the world’s most commonly used diagnostic CA125 with diagnostic efficiency of less than 60 percent for early stage detection,” Healthlinx said.
In October, Healthlinx and ARL Pathology launched the Ovplex first generation ovarian cancer test with an efficiency of 92.9 percent (see Biotech Daily; October 29, 2008).
The market interest in the first generation Ovplex has resulted in ARL Pathology establishing a wider collection network to meet the needs of women seeking the test.
Healthlinx chairman Prof Greg Rice said that the study of 107 samples of 46 disease subjects and 61 controls was small but sufficient to encourage a larger study of up to 800 samples in all.
Mr Gatsios said that trial was likely to be conducted in Singapore, Israel and the United Kingdom and cost less than $500,000.
The company said the second generation product used two new biomarkers HTX005 and HTX010.
Among the disease subjects, 35 were early stage (stage I/II) and 11 were stage III.
The sample tested included seven confirmed disease subjects where CA125 failed.
As individual biomarkers, HTX005 correctly identified five of the seven, and HTX010 correctly identified six of the seven.
Healthlinx said that where CA125 failed to detect the seven disease subjects (false negatives) the second generation Ovplex panel identified six of these cases.
“This would result in six of the seven subjects being diagnosed with early stage disease and treated accordingly,” Healthlinx said. “All seven false negatives were early stage cancers.”
The samples included four high CA125 results, assessed as being diseased (false positives) but two were subsequently confirmed by Ovplex as without disease.
CA125 would have claimed cancer in samples where Ovplex confirmed correctly in two of the four that no cancer existed.
The Ovplex second generation test used five biomarkers and achieved diagnostic efficiency of 98.13 percent, the company said.
This means that the new biomarkers identified six subjects that had been missed by CA125 (false negatives) and eliminated two subjects who would have been told they had the disease but did not (false positives), the company said.
Mr Gatsios said a Healthlinx director had provided the company with $500,000 through a convertible note arrangement and the company would undertake a private placement to raise $1.5 million to fund the development of the second generation test.
He said it would take three years from the first sales to a major country for the company to be in profit.
Healthlinx climbed one cent or 25 percent to five cents with 62,000 shares traded.
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