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Omega Diagnostics FY '09 Sales Buoyed by Array-Based Food Testing Business

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By Justin Petrone

Omega Diagnostics last week said that increased demand for its array-based food-intolerance tests contributed to a 14-percent spike in fiscal 2009 sales, according to preliminary financial results for the year.

Omega in July is set to report earnings for the year ended March 31, 2009. Based on preliminary results, FY '09 sales rose to £6.2 million ($9.4 million) from £5.44 million for the prior year.

According to the company, it experienced "substantial growth" in its food intolerance-testing line, and sales of its microarray-based Genarrayt platform rose 44 percent to £1.04 million compared to £72,000 in 2008.

As a whole, sales in its food-intolerance business segment, which also includes its FoodDetective antibody-based home testing kit, were up 31 percent to £2.96 million compared to £2.26 million in the year-ago period. In comparison, sales in Omega's infectious-disease testing segment fell 2 percent to £1.79 million year over year, while receipts in its autoimmune disease segment rose 5 percent to £66,000 year over year.

Omega CEO Andrew Shepherd told BioArray News in an e-mail this week that the uptick in Genarrayt sales was largely due to "extensive marketing" activities through Omega's worldwide distribution network, which covers 100 countries.

Of Omega's available products, Genarrayt was among the most successful, the company said. Launched in 2007, the Genarrayt 200+ Food IgG kit is a colorimetric enzyme-linked immunosorbant assay designed to measure IgG antibodies to 221 foods in whole blood, human serum, or plasma on 16-pad nitrocellulose-coated arrays.

The test enables labs to determine patients' food sensitivity by studying their reactions to specific food antigens. Omega subsidiary Genesis Diagnostics sells Genarrayt kits as well as a scanner and FoodPrint reporting software.

Geographically, total sales of Genarrayt grew across the board: In Canada sales were up 41 percent to £31,000; in Europe and Asia sales grew 13 percent and 15 percent, to £3 million and £1.4 million, respectively; Africa and the Middle East grew by 8 percent to £1.1 million; and in South and Central Americas sales rose 8 percent to £33,000.

The company's North American market is currently limited to Canada, but "[t]he US is a future target market," though only for food-intolerance testing," Shepherd said. "Timescales for [US Food and Drug Administration] approvals have to be featured in as well, so it is somewhat difficult to predict" when Genarrayt could become available to US customers, he added.

Shepherd declined to name any of Omega's Genarrayt customers. However, BioArray News previously reported that India-based clinical laboratory network Super Religare Labs had launched food intolerance-testing services based on the Genarrayt platform (see BAN 6/23/2009). Also, Auckland, New Zealand-based Praxsis Laboratories has announced that it is offering the test.

'Technical Issues,' Abandoned Plans

Omega also last week said it has abandoned plans to implement non-contact array manufacturing, which it claimed would have allowed it to cut production costs and improve yields.

In December 2009, the company stated that "technical issues" with the new non-contact printing system had forced Omega to retain its existing contact printing system. Using the current contact print method, the number of slides that can be manufactured is lower than using the prototype non-contact printing system, according to the firm.

"The supplier of the non-contact printer has been unable to resolve these issues to our satisfaction and so we have decided to remain with contact printers for the immediate future," Omega said in a statement at the time. Instead, Omega said it took "steps to increase manufacturing capacity." Shepherd confirmed this week that "manufacturing output has been increased using additional contact printers."

When it announced the manufacturing issue in December, Omega said it was "confident that future anticipated growth of Genarrayt products will be unaffected," though the firm did not rule out a "marginal increase in certain direct costs due to the slightly lower yields experienced with this method." These additional unanticipated costs caused Omega to predict that its FY '09 performance would be "marginally lower than its previous expectations." However, Shepherd said this week that the manufacturing issue did not impact Omega's results.

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