NEW YORK (GenomeWeb) – Canadian firm Phenomenome Discoveries is quietly preparing to launch a new mass spectrometry-based metabolomic test for ovarian cancer even as it waits for its financial and legal future to be resolved by a court-guided liquidation.
Saskatoon, Saskatchewan-based Phenomenome has been in receivership since Feb. 25, and will remain so until the end of July, CEO and Founder Dayan Goodenowe told GenomeWeb. Though receivership is a process to liquidate assets — Phenomenome's therapeutics, cancer diagnostics, neurological diagnostics, laboratory license and equipment, and other assets have been divided and will be sold by July 31 at the latest — it's not a bankruptcy and the company can continue to operate. Despite the fact that the assets will be sold under a closed bid process, that hasn't stopped Goodenowe from planning for the future.
"Ultimately, [receivership] is a good thing," he said. "We're going to get reinvestment in a targeted way," once the process is completed, to pursue commercialization of its clinical testing platform. "We're on the cusp of expansion," he said, with the first move being an application for Health Canada in vitro diagnostic device (IVDD) approval for the firm's OvAware ovarian cancer prediction test.
"We'll have [OvAware] approved by the end of the year," Goodenowe predicted. For all the uncertainty hovering over the company, there's confidence in its work validating OvAware.
Last week, the firm announced results from two studies validating the blood test. In both a large Canadian study — with 325 ovarian cancer patients and 1,041 controls — and a smaller Japanese study with 112 ovarian cancer patients and 99 controls, OvAware was able to detect ovarian cancer with 97 percent accuracy. "We got exactly the same results in two diverse geographical regions of the world," Goodenowe said.
Goodenowe framed the studies — which are not yet published but will be presented at the Cancer Diagnostics and Expo in Rome, Italy in June — as proof of the value the company has built over the years.
"Our company is founded on a metabolic discovery platform called non-targeted metabolomics," he said. Using mass spectrometry, the firm can measure small molecules in blood or other sample types using its Clinical Analyzer Platform. Triple quadrupole mass spec technology from Ionics Mass Spectrometry, a PerkinElmer company, has allowed the firm to both discover new biomarkers for diseases as well as develop clinical tests looking at those biomarkers. The platform also features Gilson automated liquid handling.
Specifically, Phenomenome is able to detect markers that signal the onset of disease, Goodenowe said. "You don't go to bed healthy and wake up with cancer." Instead of waiting to detect tumors, Phenomenome "looks for the person who will get the tumor."
The OvAware test looks at fatty acid elongation and desaturation, a process that happens when cells begin to proliferate, Goodenowe said. "For ovarian cancer, 10 percent of women are primed to get it," he said. "And over 90 percent [of cases] will occur in that 10 percent." OvAware is supposed to pick out those 10 percent who are at risk and identify them for closer monitoring.
Because the disease progresses so quickly, it's difficult to catch while still in its early stages. "You'd have to be monitoring extremely frequently in order to pick up that change," Goodenowe said.
Phenomenome is also built to help with that, with the ability to process thousands of blood samples a day and with population-based screening tests requiring only a spot of blood on a paper card in the works. While OvAware is not currently validated as a blood spot test, it is something Phenomenome is working on.
"Our technology is advanced in terms of discovering metabolic abnormalities," Goodenowe said. "But the delivery is standard clinical chemistry." The clinical analyzer is US Food and Drug Administration compliant and the company has an ISO certified manufacturing facility.
These features lead Goodenowe to believe the diagnostics component of Phenomenome has a future.
"All of our products are designed for population screening and we have a technology platform to handle that kind of volume and distribution," he said. The clinical analyzer is a "black box" that can be shipped to any lab to operate, even if it's not experienced in working with mass spec. "As we build additional testing tech, it can all be run on the same platform," Goodenowe said.
But building out the diagnostic menu will take investment, something Phenomenome cannot begin working on until the sale of its assets is finalized. Currently, the company and the consultants facilitating the receivership are in the midst of a road show to present the opportunities. They stopped in Copenhagen earlier this month and will be visiting Tokyo, Shanghai, Hong Kong, and San Francisco in the coming weeks.
Once the sale is finalized, Phenomenome will immediately apply for Health Canada IVDD approval for OvAware and then turn its sights on the US market.
Phenomenome hasn't decided whether it will go the laboratory developed test route, seek a 510(k) approval from the FDA, or seek pre-market approval. However, Goodenowe said the 510(k) would be appropriate for a disease as rare as ovarian cancer.
While everything will be sold, Goodenowe left open the possibility that existing Phenomenome shareholders could buy up certain assets. He is the majority shareholder in the firm. Whoever the owners are, "The asset development path will then continue under the new ownership," Goodenowe said. "I am confident that the development will continue without any delays."