Spectral Diagnostics, a Canadian biotech shop, hopes to use approximately $8 million in cash and other investments to develop an in vitro diagnostic for West Nile virus that health-care workers can employ in the field, a company official told SNPtech Reporter.
While an immunoassay for the pathogen is currently approved for use in the United States, the test proposed by Spectral Diagnostics will require smaller blood samples, and may be able to provide results in minutes rather than hours or days.
And with the incidence of West Nile infections growing each year, the assay, if approved in the US and Canada this summer in time for West Nile season, may be an economic boon for the company, as well as an important validation for IVD technology.
“There are numerous diseases out there that have become extremely important … in the last few years,” said Paul Walker, Spectral Diagnostics’ CEO and a chief architect of the joint venture. “This project is a major drive for us to become profitable.”
To that end, the Toronto-based company this week launched a joint venture with two large Canadian venture-capital funds to begin researching and developing the West Nile assay. The VC shops, which include the Canadian Medical Discoveries Fund and MDS Capital — will together invest $2 million in the JV and subscribe to $4 million worth of shares in it, while Spectral Diagnostics will provide $2 million in technology. The JV, called IDx, will be equally owned by the VC group and by Spectral Diagnostics.
Spectral Diagnostics designs, manufactures, and sells assays for cardiovascular disease and sepsis. Its main distributor is Cardinal Health, which markets the products in the United States. They are sold internationally by a number of different companies. Walker said Spectral Diagnostics would seek regulatory approval for the tests in the United States and Canada as in vitro diagnostics.
Spectral Diagnostics hopes to develop the new tests using technology that helped create its two existing products, Walker said.
Though he declined to describe the company’s antigen-detecting platform, he said it enables labs to obtain accurate results using a pin-prick of blood. This advance, he said, would allow individuals to be tested in the field or wherever traditional testing equipment might be scarce.
“We can get the same sensitivity out of a 50-microliter sample as [we] would out of a 200-microliter sample,” he said. “It may be done virtually anywhere by anybody. That’s the major thrust and the major advantage.”
West Nile virus belongs to the flavivirus family, a group of single-stranded RNA viruses typically 10,000-11,000 bases long, according to the US Centers for Disease Control and Prevention. Spectral Diagnostics’ West Nile assay will test for antigens to this virus.
While the flavivirus family also includes the viral agents of Dengue fever and yellow fever, Walker did not say whether his company will try to develop assays for these diseases. He did say, however, that Spectral Diagnostics “will likely move into other areas when the [joint venture’s developmental] platform is worked out.”
Walker said these tests will initially be sold in North America and eventually in Europe. He called Canada and the United States the “two biggest markets” for a West Nile test: “This is where our distribution associations are the strongest,” he said.
If Spectral Diagnostics is able to develop and sell the test it will hit clinics at a critical time in the increasing incidence of the disease. Labs in North America perform around 500,000 tests for the infection each year, “and the disease is continuing to expand,” said Walker.
Though it was virtually unheard of in the United States or Canada several years ago, the infection is now found in all 50 American states, and all 10 Canadian provinces. In 2003, there were 8,912 known cases of West Nile infection and 211 registered deaths from the disease in the United States as of Dec. 17, according to the CDC. Health Canada, meantime, reported 466 confirmed cases of the disease and 10 deaths as of Dec. 18. “The potential market is very large,” said Walker.
A test for West Nile virus currently exists. Approved in the United States last July, the immunoassay, called the West Nile Virus IgM Capture ELISA test, was developed by Australian biotech company PanBio. Results of that assay, which is the first of its kind for the West Nile virus, must be confirmed by a follow-up test, the FDA said.
Spectral Diagnostics, which is based in Toronto, employs 100 people and has satellite offices in Whitestone, Va., and in Europe. Walker said the company does not intend to hire new researchers or sales people to develop or roll out the new assays.
The company currently markets a test that measures markers of myocardial infarction — called the Cardiac STATus test — and an assay for sepsis, called the Endotoxin Activity Assay.