Australian diagnostics firm HealthLinx said this week that it has signed a deal with Seoul Clinical Laboratories for commercial distribution of its OvPlex ovarian cancer diagnostic in South Korea.
With the agreement, HealthLinx now has distribution deals for the protein biomarker-based test in the UK, Australia, Singapore, Israel, and South Korea, with sales of OvPlex currently ongoing in the UK, Australia, and Singapore after launches in those countries earlier this year.
Those launches, along with the start of sales of Vermillion's ovarian cancer diagnostic OVA1, suggest that, after years of stops and starts, proteomics-based diagnostics – for ovarian cancer, in particular – are at last making headway.
However, while HealthLinx and Vermillion have had success bringing their tests to market, their sales numbers thus far have been rather anemic – indicating that, while these diagnostics have managed to overcome the technology and regulatory hurdles in their way, achieving widespread adoption remains a challenge.
In its annual report for its 2009 fiscal year, ended June 30, 2009, HealthLinx predicted sales of 5,000 OvPlex units in the UK and sales of 500 units in Singapore by the end of its 2010 fiscal year. Such volumes, the company noted, would result in total revenues of more than A$350,000 ($342,000).
However, in its 2010 annual report, the company reported total product and royalty revenues of A$12,757 and noted that OvPlex sales were "modest," though it did not break out unit sales.
By Sept. 30, 2010, HealthLinx had sold just over 100 tests in the UK since launching the test there in February and just over 50 tests in Singapore, according to its quarterly report.
HealthLinx also acknowledged in the 2009 report that sales of OvPlex had "not achieved projected targets within Australia." Sales of OvPlex in the country began in October 2008 but were temporarily suspended in September 2009 when its domestic distributor, ARL Pathology, was acquired by the healthcare provider Healthscope. Before the pause, the company sold roughly 200 tests. It relaunched the test through Healthscope this June (PM 06/18/2010).
Vermillion has similarly had to back down from overly aggressive predictions regarding its OVA1 ovarian cancer diagnostic. In a document filed with the SEC in December 2009, the company predicted $9.7 million in revenue from sales of OVA1 in 2010 and $34 million in 2011. As of the end of Q3 of 2010, however, it had booked just $159,000 in OVA1 sales, and on a Q3 earnings call, CEO Gail Page lowered the company's 2010 guidance from a range of 8,000 to 10,000 OVA1 sales to a range of 5,000 to 5,500 sales for the year (PM 11/12/2010).
During the Vermillion earnings call, Page noted that the company had underestimated the effort required to convince doctors of OVA1's utility and said that it planned to refocus its sales force to concentrate more heavily on educating gynecological oncologists about the test. An article published this July in the Australian newspaper The Age suggested that HealthLinx might be running up against a similar problem.
In the story, several prominent doctors, including Helen Zorbas, CEO of Australia's National Breast and Ovarian Cancer Centre; Michael Quinn, a gynecological oncologist at the Royal Women's Hospital and the University of Melbourne; and Peter Grant, head of the department of gynecological oncology at Melbourne's Mercy Hospital, criticized the lack of data supporting the test, saying that further studies were needed to determine its clinical usefulness.
In September, Quinn, who sat on HealthLinx's scientific advisory committee until 2008, was ordered by an Australian court to refrain from making any statements regarding the OvPlex test. In an e-mail to ProteoMonitor predating the order, however, he suggested that longitudinal studies following symptomatic women to determine the test's sensitivity and specificity would be particularly useful in demonstrating its value.
For now, though, HealthLinx is concentrating on a 1,150-subject study to establish the utility of adding two biomarkers to the test's current five-protein panel. "At the moment we're just focusing on this particular study," managing director Nick Gatsios told ProteoMonitor. "We've got to get over this study first and then we'll worry about other studies that might be in the pipeline."
The OvPlex test currently on the market uses blood levels of C-reactive protein, serum amyloid A, interleukin 6, interleukin 8, and CA125 to aid in the early-stage diagnosis of ovarian cancer in symptomatic women. The company is now evaluating the proteins AGR2 and HTX010 as possible additions to the existing panel. The hope is that the additional markers will boost the test's sensitivity and specificity from 94 percent to 97 percent.
According to Gatsios, initial data from 450 samples suggest that adding the markers will increase the test's performance. "[The data] is consistent with what we expected," he said. "The way we modeled it previously in a small dataset showed that it would increase the performance of the assay. This data looks pretty promising that it will do the same."
HealthLinx is now collecting samples for the next stage of the study, which will involve 700 subjects. Gatsios said the company hopes to have that stage completed in the next 12 to 14 months, but, he noted, "it's just a matter of waiting for women [who] present with the symptoms that meet our inclusion criteria to walk in the clinic – and you can't predict that. Our clinicians have been collecting now for quite a few months."
The company received an A$750,000 grant from the Victoria government in November 2009 to support the study. It has been obtaining patient samples from the Mater Hospital in Queensland and from several sites in the UK.
HealthLinx is also embarking on trials required by the South Korean Food and Drug Administration for the sale of OvPlex in South Korea. In September it finalized plans for a 220-patient study to be conducted by Byoung-Gie Kim of Samsung Medical Center and Sungkyunkwan University School of Medicine. That study is also anticipated to take 12 to 14 months, after which submissions to the KFDA will begin. According to HealthLinx's estimates, the South Korean market for OvPlex is roughly 250,000 tests annually.
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