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Allergy Testing Lab US BioTek to Add New Tests, Expand Internationally


NEW YORK (360Dx) – Under new ownership, Shoreline, Washington-based immunology and allergy testing laboratory US BioTek is planning an expansion that will include adding new testing panels, growing its international distribution, and launching an information campaign to raise awareness of food sensitivity testing.

The expansion of the nearly 20-year-old lab company is being funded by investments announced last month from Seattle-based private investor group Pike Street Capital, which acquired a majority stake in US BioTek, and Capitala Group, which announced an investment of $19.5 million in senior secured debt and equity. Terms of Pike Street Capital's investment were not disclosed.

US BioTek has long offered immunoglobulin G and A antibody testing for food sensitivities as well as immunoglobulin E allergy testing, and the IgG/IgA food sensitivity testing has been the lab's biggest growth areas, according to Jack Frausing, US BioTek's new president and CEO. The company offers a standard IgG/IgA panel of 96 different food sensitivities, as well as separate 96-food sensitivity panels targeted toward Asian food, Japanese food, Mexican food, and vegetarian food, he said. As part of its expansion, the company will add more IgG/IgA sensitivity panels for more food areas, he said. The company has also recently begun offering IgG/IgA inhalant testing for potential irritants such as pollen and mold, he noted.

The growth of IgG and IgA food sensitivity testing has been somewhat controversial, as not all physicians support its use. US BioTek notes on its website that the US Food & Drug Administration considers IgG/IgA food sensitivity testing to be of an investigational or research nature, and the lab recommends that the test results be evaluated by a healthcare practitioner who understands the limitations of the tests.

The laboratory is planning an educational campaign related to IgG/IgA testing, including adding informational material to its website written by physicians or clinicians who are familiar with the tests, as well as sponsoring informational webinars, and making experts available at conferences to talk about the testing and its implications, according to Frausing.

"One thing that we have realized is that education is a big deal around issues like how do you use the tests in the optimal way, and how do you interpret results. Addressing those issues is a big part of what we want to do on the educational side," he said.

US BioTek's IgE allergy testing is performed on the Siemens Immulite Immunoassay System, which uses enzyme-amplified chemiluminescence technology, he noted. The company uses enzyme-linked immunosorbent assay, or ELISA, testing for IgG/IgA food sensitivity testing and for inhalant testing, he said.

Along with expanding the number of panels it offers and ramping up its educational effort, US BioTek is planning an international expansion, Frausing said. The company already has distributors in Asia, including in Japan and Indonesia, as well as a distributor in Northern Europe. US BioTek is planning further expansion in in Asia along with a move into more central and southern regions of Europe.

"Currently we do have distributors, but we don't have a lot, and there hasn't been a focused effort to build a distribution network, so that is an area that we want to expand on," Frausing said.

Much of the testing performed by US BioTek is finger-prick testing, through which drops of blood are captured on absorbent pieces of paper that can be easily sent via FedEx to US BioTek's lab in Shoreline for processing, he said. US BioTek's lab has CLIA and COLA certification and there have not been signficant regulatory hurdles to accepting tests from patients in other countries, he noted. The company may explore building labs in other areas in the future, depending on the rate of expansion, but for now there is plenty of capacity to accommodate additional testing volume growth within the existing facility, Frausing said.

Driving international expansion was one of Frausing's motivations for joining US BioTek. Prior to joining the lab, Frausing headed global sales for Radiant Vision Systems where he built a distribution network in Asia and Europe, while overseeing a sales team in the US.

Pike Street Partners, whose team Frausing knew prior to joining US BioTek, has a history of investing in middle-market companies that are founder-run and positioning them for new types of growth, such as geographic expansion, he said. Pike Street has been instrumental in bringing a new chief financial officer on board and helping to organize the new corporate structure upon acquiring the lab company, he said. US BioTek's Founders, Raymond and Margaret Suen, who had served as president and executive vice president respectively, remain with the company as advisors to the lab.

To accommodate potential growth, the company, which has approximately 40 employees, is planning to add 10 more employees in a variety of roles in the short term, Frausing said. There may also be additional equipment added to the Shoreline laboratory, he noted.

Frausing hopes the planned educational campaign, as well as the test menu and geographic expansion, will help raise US BioTek's profile.

"US BioTek has been a little bit of a secret in terms of its existence. They haven't focused much on marketing and expanding their channels and so that's really where I see the growth coming from," Frausing said.