AutoGenomics this month introduced an assay panel for mutations implicated in the development of familial Mediterranean fever.
The new assay, which is currently available for research use only, runs on the firm's array-based Infiniti system and provides multiplexed determination of 13 genetic variants common to more than 10 afflicted ethnicities of Mediterranean origin.
According to Ram Vairavan, AutoGenomics' senior vice president of sales and marketing, the Vista, Calif.-based molecular diagnostics firm anticipates that the assay will gain a CE Mark later this quarter. The firm also plans to eventually submit the panel to the US Food and Drug Administration for 510(k) clearance.
Vairavan said that AutoGenomics expects a CE Mark for the assay in March. He said it was "difficult to assess" when the privately held firm would submit the panel to the FDA, but added that such a submission is "certain" and that AutoGenomics will start accumulating clinical data toward that goal.
The 12-year-old company has won FDA clearance for a number of its assays to date, including its Factor II, Factor V Leiden, and Factor II/V Leiden panels; its warfarin assay; and its CYP450 2C19+ assay. A number of panels have already been submitted to the FDA or are undergoing a pre-investigational device-exemption process with the agency, including an HPV genotyping panel, which is designed to detect 26 human papillomaviruses.
"We do have a number of other applications with the FDA and we are at this stage in discussions with them, providing them with additional data," Vairavan said.
He added that the firm also plans submissions for its KRAS and BRAF mutation assays, which are currently available for research use only.
"We are actively involved in the US and we want to get most of these products FDA cleared," he said.
The FMF panel will be different: If approved by the FDA, is will become the first of AutoGenomics' assays to target a market outside the US.
"Today there is a very high incidence [of FMF] in countries around the Mediterranean," Vairavan told BioArray News this week. "Our distributors out there think this would be one of the highest-volume tests in these countries. We are also beginning to realize that it has a high incidence in other markets, such as here in the US and in Canada."
FMF is a hereditary inflammatory disorder caused by mutations in the gene MEFV. According to the National Institutes of Health, symptoms of the disease include recurrent episodes of inflammation and serositis including fever, abdominal pain, chest pain, joint pain, and skin eruption. FMF is frequently found in people of Armenian, Jewish, Greek, Arab, and Turkish descent.
While prevalent in Mediterranean and Middle Eastern countries, FMF is manageable with the use of anti-inflammatory drugs. "It is important that you get diagnosed that you do have this disease," Vairavan said. "Once you have that, then there are therapeutic treatments available."
Vairavan said that AutoGenomics developed the panel internally, but that the demand for the assay came as a "special request" from some distributors because of the high incidence of FMF in those countries.
Omer Sen, president and CEO of the CDK Group, an Istanbul-based molecular diagnostics firm that distributes AutoGenomics' tests in Turkey, said that FMF is a "very serious problem in affected populations" and that the new test is a "critical tool" for the firm.
Infiniti and Beyond
AutoGenomics' new test runs on its automated Infiniti Analyzer platform. The firm claims on its website that the system integrates all test processes such as sample handling, reagent management, hybridization, stringency, and detection. The firm's assays are based on its BioFilmChip array platform, which consists of multiple layers of hydrogel matrices about 10 µm thick on a polyester solid support.
Vairavan said that AutoGenomics' platform differs from other array platforms used in molecular diagnostics, such as the Affymetrix or GenMark Diagnostic systems, in that it offers "load and go" automation.
"Right now, most other platforms require sample preparation outside the instrument," he said. With the Infiniti, "once PCR product is put into instrument and the reagents are loaded, the instrument automatically provides primary extension followed by hybridization, reads the sample, and prints out results. There is no manual intervention required, and results are automatically displayed."
According to Vairavan, the Infiniti system is now being sold in more than 20 countries worldwide, including other potential markets for the FMF test, such as Italy, France, and Spain.
"Our whole focus has been on the US, looking at how the molecular testing market is evolving and what are the specific needs for panels," Vairavan said of AutoGenomics. "This test came as a request from Europe."
While privately held AutoGenomics strategizes about reaching those markets, it is still waiting to proceed with an initial public offering. The firm originally filed an S-1 with the US Securities and Exchange Commission in 2008 and updated it last summer.
Vairavan said this week that an IPO is "still something we are planning to do," but that it is the "bankers that will have to make the call as to when the time will be appropriate."
He added that "as soon as the market is ready we will be ready to go."
According to its August 2010 amended S-1, AutoGenomics posted $5.9 million in product sales and about $19 million in net losses in 2009. For the three months ended March 31, 2010, product sales fell 38 percent to $751,000 from $1.2 million in the year-ago period, while net loss widened 11 percent to almost $4.8 million from $4.3 million in Q1 2009.
As of March 31, 2010, the company had $4.1 million in cash and cash equivalents.
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