Australian biomarker and diagnostic firm HealthLinx said this week that it has resumed Australian sales of its OvPlex ovarian cancer test and has begun an international trial aimed at adding two new protein biomarkers to the test's five-biomarker panel.
The trial will study samples from 1,150 patients in Australia and the UK to explore the utility of adding biomarkers AGR2 and HTX010 to the test. Initial results indicate that the addition of these markers could improve the test's sensitivity and specificity from 94 percent to 97 percent, Nick Gatsios, HealthLinx managing director, told ProteoMonitor. By comparison, CA125, presently the standard test used to detect ovarian cancer, has a sensitivity of 92.6 percent and a specificity of 89.6 percent.
The biomarkers currently comprising OvPlex are CA125, C-reactive protein, serum amyloid A, interleukin 6, and interleukin 8. The test uses an algorithm to generate a score between zero and 1, which corresponds to the likelihood that a woman has ovarian cancer.
The study to expand the test's biomarker panel from five to seven proteins consists of two stages. The first will examine 450 samples, which the company has already banked and is preparing to screen. Gatsios estimated that results from this first stage will be available within the next three to six months.
The second stage will look at an additional 700 samples collected at the Mater Hospital in Queensland and several sites in the UK. Results from this portion of the study are roughly a year off, Gatsios said.
"We hope it's going to be 12 to 14 months, but we can't really predict that," he said. "It's a matter of how many women go through the physicians' facilities who meet our inclusion criteria."
In November 2009 HealthLinx received an A$750,000 ($647,000) grant from the Victoria government to support the trials.
The company is also resuming Australian sales of the current OvPlex test, which began in October 2008 but were temporarily suspended in September 2009 when the test's Australian distributor, ARL Pathology, was acquired by Healthscope. The pause in sales was needed in order to perform correlation studies ensuring that the test functioned properly after the move from ARL to Healthscope, Gatsios said.
The move to Healthscope, which has more than 340 collection centers across Australia compared to 35 formerly run by ARL, will significantly expand the test's distribution.
Roughly 90,000 conventional CA125 ovarian tests are performed in Australia each year, which, Gatsios said, is the best measure of the potential market for the OvPlex test. Under HealthLinx's distribution agreement with ARL, OvPlex achieved close to one percent market share. Moving forward under its agreement with Healthscope, the company hopes the test, which is available through general practitioners and costs A$200, will achieve 15 percent to 20 percent market share over the next several years, Gatsios said.
HealthLinx launched the test in the UK in February, distributing it there through its partner Intus Healthcare. It plans to start selling it in Singapore in July using Singapore-based medical firm Inex as the distributor. Inex also has distribution rights in Malaysia, Indonesia, Vietnam, Thailand, and India. The company plans to start sales of the test in Malaysia and Indonesia over the next year and to begin the process of obtaining regulatory approval in India. Based on the number of CA125 tests currently being sold, these countries represent a market for over one million units, Gatsios said.
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The company is also pursuing a distribution partner for the test in the US and Canada. Once it secures such a partner, it will begin seeking approval from the US Food and Drug Administration, Gatsios said.
"We're in discussion with a number of groups to partner the technology for North America," he said. "Once we've [found a distributor] we'll probably proceed with a pre-submission to the FDA to get their feedback and their comments on the study design and, if there are any variations required, adopt those variations and proceed with a US patient cohort."
According to HealthLinx's 2009 annual report, over 8 million CA125 tests are sold in the US each year.
Worldwide, over 230,000 new cases of ovarian cancer are diagnosed each year, with more than 142,000 women dying of the disease. In addition to HealthLinx, several other companies have developed protein biomarker-based tests for the cancer. Vermillion launched US sales of its OVA1 test in March. Arrayit is pursuing FDA approval of its OvaDx test.
Correlogic is also pursuing FDA approval of its OvaCheck test. The company expects to begin marketing the test in Europe in several months, after recently having obtained CE marking from the European Union (PM 6/11/2010).
In October 2009, HealthLinx secured A$7.23 million from US institutional investor SpringTree Special Opportunities Fund to fund day-to-day operations including the further commercialization of the OvPlex test. This month it raised an additional A$750,000 through private placement of 7,500,000 ordinary fully paid shares.
"We're reasonably well placed in cash right now," Gatsios said, noting, however, that the company has additional products in development that could lead it to seek more funding in coming months.
He declined to say specifically what those products are but said that HealthLinx will be releasing information on one test in particular in the near future.
In its 2009 annual report, the company identified prostate cancer, colorectal cancer, and pancreatic cancer as diseases for which it was developing diagnostics. The report noted, however, that these projects had been put on hold "due to the credit crunch" caused by the global economic slowdown (PM 03/19/2010).
In a statement released this week, the company identified OvPlex and a prostate cancer diagnostic as its first commercial targets.