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Healthlinx Launches OvPlex in UK, Heating Up Race to Get Ovarian Cancer Dx to Market

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This story originally ran on March 18.

By Tony Fong

Australian biomarker and diagnostic firm Healthlinx last month launched its OvPlex test in the UK, as the race to bring ovarian cancer diagnostics to the market warms up.

Melbourne-based Healthlinx launched the five-protein panel in the UK and the Republic of Ireland following its initial introduction in Australia in October 2008, which the company said made OvPlex the world's first protein-based ovarian cancer diagnostic to be commercially available.

This week, Healthlinx announced that its UK distribution partner, Intus Healthcare, had formed a scientific advisory board to "oversee the use and distribution" of OvPlex in the UK.

In addition to the UK, Healthlinx said the firm expects OvPlex to become available in Singapore and other parts of Southeast Asia this year, reaffirming remarks the company made in its 2009 annual report, in which it said that over the next 18 months to two years it "plans to target" China, South Korea, and parts of Eastern Europe for the test. In the report the company added it intends to debut the test in the US in 2011.

After several years of stops and starts and some high-profile setbacks, proteomics-based diagnostics appear to be finally making some headway into the market, led by tests for ovarian cancer. And according to one industry observer, they could grow significantly in the next few years.

Along with Healthlinx, Vermillion last week launched its OVA1 test in the US, while Arrayit is pursuing regulatory approval of its test, OvaDX, in the US. Correlogic also is pursuing approval from the US Food and Drug Administration for its test called OvaCheck.

To be sure, that hardly signals a trend, but as Harry Glorikian from life sciences consulting firm Scientia Advisors, said, "We know there will be quite a bit of new products entering the market. That will affect the strategy of many companies as competition heats up, pricing is affected, and go-to-market plans get adjusted."

Improving on CA125

Healthlinx's OvPlex is based on a panel of five biomarkers detected in blood, including CA125. OvPlex, the company said, is more effective at detecting ovarian cancer than CA125 alone, the current standard for diagnosis.

The other biomarkers comprising OvPlex are C-reactive protein, serum amyloid A, interleukin 6, and interleukin 8. An algorithm generates a score between zero and 1, which corresponds to the likelihood that a woman has ovarian cancer.

When it launched the product in Australia, Healthlinx said that in clinical trials, OvPlex achieved 89.2 percent sensitivity and 93.9 percent specificity. In a study published earlier this year in the Journal of Cancer Research and Clinical Oncology, researchers from HealthLinx and Australian universities and institutions found that OvPlex achieved a sensitivity of 94.1 percent and a specificity of 91.3 percent at a threshold of 0.3 for the validation cohort.

In comparison, CA125 alone had a sensitivity of 92.6 percent and a specificity of 89.6 percent. For overall accuracy, OvPlex achieved 92.7 percent, compared to 91.1 percent for CA125 alone.

In the early-stage cohort, OvPlex achieved sensitivity of 92.3 percent and specificity of 91.3 percent, while CA-125 alone had sensitivity of 89.7 percent and specificity of 89.6 percent.

The company did not respond to several requests for an interview and e-mailed questions, but in the study, the authors wrote that the diagnostic performance for the panel was "significantly greater than the [performance] for CA125 alone for a validation cohort and an early stage disease cohort."

OvPlex is for early stage detection of ovarian cancer and Healthlinx said that the test "has been validated for women who are at higher risk or have symptoms of ovarian cancer."

The company is now in the process of evaluating OvPlex in a larger multi-site trial and possibly including two biomarkers, HTX005, also known as AGR2, and HTX010 "that have shown promise as ovarian cancer biomarkers in preliminary studies," Healthlinx said in its annual report.

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The trial will evaluate OvPlex using 1,190 patient samples, and includes collaborators from Mater Health Services in Brisbane, Australia; Young Loo Lin School of Medicine at the National University of Singapore; the South Essex Cancer Network in the UK; and the University of Liverpool in the UK, Healthlinx said in a statement last month.

Last fall, Healthlinx said it had secured A$7.23 million ($6.6 million) to conduct the trial and help commercialize OvPlex. It also was awarded a A$750,000 grant from the Victorian government.

In its annual report, Healthlinx said its objective "is to increase the diagnostic efficiency of OvPlex to greater than 97 percent, and larger trials and testing of additional biomarkers are imperative for achieving this goal."

The trial, it added, "will also see the possibility of partnering the technology with
a larger and more progressive group that can accelerate distribution and regulatory approvals in North American and other strategic jurisdictions."

Its strategy for North America is to partner with a firm with established distribution channels in the "lucrative US market," which it said is the largest in the world for any health product. In addition, any potential partner should have "in-house trials capabilities to assist in study design and regulatory approval processes;" a strong track record in partnering on diagnostic technologies; and the ability to scale up on antibody and ELISA production.

"We are confident that we will secure this partner in the near future and that OvPlex will deliver an incremental health benefit to women globally," the company said. "With the anticipated positive results from the second study, it is our intention that in 2011, OvPlex will be available through our chosen partner to all women in the United States."

More than 8 million CA125 tests are sold in the US, the company said, and OvPlex will directly target that market. Worldwide, 240,000 new cases of ovarian cancer are diagnosed each year and 130,000 women die from the disease, Healthlinx said.

As of the end of its fiscal year, June 30, 2009, sales of the test in Australia had exceeded 200 units since its launch in late 2008, and in the UK, the company said it anticipates selling more than 5,000 units of OvPlex in about the first six months of its launch, Healthlinx said in its annual report.

In support of the launch in the UK, Healthlinx said that Intus Healthcare, its distribution partner in the UK, had formed its scientific advisory board. The members are Amrit Takhar, Malcolm Padwick; Fergus Macpherson; Louise Bayne; and Sean Kehoe.

In addition to OvPlex, Healthlinx is targeting diagnostics for prostate cancer, colorectal cancer, and pancreatic cancer, though those projects have been on hold "due to the credit crunch" caused by the global economic slowdown, the company said.

Healthlinx's lead technology is the Cryptomics platform, which the firm describes on its website as a "novel compound-discovery platform that can significantly accelerate the discovery of novel proteins for nutraceutical and therapeutic use."

In general, the Cryptomics platform "entails a suite of technologies" involving fragmentation mainly by enzymes; LC separation; cell and non-cell-based bioassays to monitor bioactivity of protein fragments; and mass spectrometry for protein fragment identification.

Healthlinx has also developed greater than 200 cryptein libraries from more than 20 material sources, including individual proteins, protein complexes, cell lysates, and body fluids. Proprietary methods were developed by the company in order to create the libraries, Healthlinx said.

According to the Healthlinx's annual report, the firm posted receipts of A$201,216 for fiscal 2009 ended June 30, 2009, down 62 percent from receipts of A$534,788 in fiscal 2008. Loss attributable to members in 2009 rose 36 percent to A$1.9 million from A$1.4 million the year before.

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Dx Firms Eyeing Ovarian Cancer

The UK launch of OvPlex is the latest of a sudden flurry of activity surrounding similar proteomics-based tests for ovarian cancer after several false starts. Just last week, Vermillion launched its OVA1 test after becoming the first proteomic in vitro diagnostic multivariate index assay to be cleared by the FDA [See PM 03/12/10]. A five-protein panel, OVA1 can indicate the likelihood of ovarian cancer with high sensitivity before a biopsy or exploratory surgery, Vermillion said [See PM 09/17/09].

In December 2009 Arrayit announced it would be seeking FDA approval for its OvaDx microarray-based test for the screening of ovarian cancer for a market launch sometime this year [See PM 01/08/10]. The company did not provide an update on its application for this story.

Scientia Advisors' Glorikian said that following the entry of genomic molecular diagnostics into the marketplace a few years ago, it was foreseeable that protein-based products would soon follow.

"We said this about four years ago and the prediction was [that] protein-based products would lag by four to five years, so we are entering the window," he told ProteoMonitor by e-mail. "That window, however, shifts depending on the maturity of the area and our understanding of the disease."

Just in the past few years, the number of molecular diagnostics — both genomics- and proteomics-based — in the development pipeline has grown "at an incredible rate and will have a dramatic impact on the practice of medicine," Glorikian added.

If that forecast comes true, it would be a far cry from as recently as a year and a half ago when the future of such protein-based cancer diagnostics looked uncertain at best. It was then that LabCorp launched OvaSure, a six-biomarker test co-developed with researchers at Yale University as a CLIA test in 2008. But under pressure from the FDA, which said the test was under the purview of the agency and therefore was not allowed to be marketed without its approval, LabCorp withdrew the test [See PM 10/30/08].

Before that, Correlogic had been developing its OvaCheck test for the early detection of epithelial ovarian cancer since 2002. That test also ran into a series of snags with the FDA, however, the most recent in 2007 when the agency said it was going to begin regulating tests such as OvaCheck that use algorithms to interpret complex gene and protein data [See PM 02/15/07].

The future of both OvaSure and OvaCheck are unclear. LabCorp did not respond to a request for comment.

In an e-mail, Annette Fribourg, a spokeswoman for Correlogic, said that following a double-blinded clinical trial completed in late 2008, the company filed a 510(k) application with the FDA. Correlogic has been "engaged in discussions with the agency since then regarding the appropriate regulatory pathway," she said, adding the firm is in the process of obtaining a CE mark in Europe.

In the meantime, Healthlinx officials said that the OvPlex puts the company at the forefront of the ovarian cancer diagnostics market.

In a statement, Nick Gatsios, managing director of Healthlinx, said that the UK launch of OvPlex is the first "large-scale rollout" of the test and could trigger launches in other countries of "what we feel is a superior diagnostic for ovarian cancer to any other product available

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