Hygiena Acquires Helica Biosystems, Receives AOAC-RI Certification for GlutenTox Pro Test

Camarillo, Calif.-based Hygiena, a Warburg Pincus portfolio company that specializes in rapid food safety and environmental sanitation testing, acquired Helica BioSystems, Inc., based in Santa Ana, Calif., effective March 28. Helica specializes in the development of enzyme linked immuno-assays (ELISA) that can detect mycotoxins, a family of highly toxic chemicals that are naturally emitted by specific fungi which are a persistent problem in dairy, grain, feed, food and beverages products. Maximum acceptable levels of mycotoxins are very low (in the parts per billion range) due to their extreme toxicity, and the toxins can cause a variety of health problems such as liver cancer, kidney complications, stunting in children, and many other conditions.

Helica supplies a full menu of mycotoxin detection tests as well as research test kits for testing inflammatory markers such as C-Reactive Protein for the pharmaceutical industry. In addition, the company offers contract research and private label manufacturing services. One of Helica’s best-selling tests is for aflatoxin M1, a type of mycotoxin that persists in milk and other dairy products.

With the addition of these tests, Hygiena expands its portfolio of food safety and quality assurance products offered to its global customer base. Helica’s products complement Hygiena’s allergen detection (which include other ELISA- and lateral flow-based tests), ATP, and pathogen detection product portfolios.  

 “We are excited to welcome Helica to the Hygiena family and to include its products and services in Hygiena’s food safety testing portfolio,” said Hygiena CEO Steven Nason. “Helica’s products are known for their versatility and quality, and we are prepared to build on the company’s existing presence in developed and emerging markets.”

Helica’s operations will remain in Santa Ana, and all Helica employees will become employees of Hygiena. Helica’s products will be available through Hygiena’s global commercial sales team as well as the global network of distributor partners. Hygiena also will continue Helica’s research initiatives aimed at developing new assays for food safety.

“We are excited to join Hygiena,” said Helica CEO Wondu Wolde-Mariam. “Helica has come a long way, starting in a garage to now becoming part of the world’s leading provider of food safety products. Our R&D and production facilities are certified to the ISO 13485:2016 standard, and our quality is second to none.”

Hygiena also announced that its GlutenTox Pro test for the detection of gluten received a renewal and transfer of its certification to Hygiena from the AOAC Research Institute.

The renewal under the AOAC Performance Tested Methods Program certifies that GlutenTox Pro performs according to Hygiena’s specifications. Data from the test showed that the test:

• Performed as expected in rice flour, bread, rolled oats, paté, and yogurt, and had a detection threshold of 5 parts per million (ppm); 20 ppm is the international limit indicating “gluten free.”
• Showed no cross-reactivity to any compounds, and showed 100% specificity, with no false negative results.
• Showed 100% specificity when tested on environmental surfaces (food-grade painted wood, plastic, rubber, sealed ceramic and stainless steel).

Data submitted to the AOAC-RI also demonstrates how well the test performs in a variety of environmental surfaces and in foods with different composition and degrees of processing, the company said.

GlutenTox Pro is manufactured by Hygiena Diagnostica España S.L., based in Seville, Spain. The division provides a large set of specific allergen tests including AlerTox and GlutenTox line of products available in a lateral flow “dipstick” format that can be used to verify cleaning efforts and test finished products and raw material. The tests are also available as a sensitive enzyme linked immunosorbent assay (ELISA) format. The unique G12 antibody used in GlutenTox Pro and other Glutentox line of products detects the causative agents of gluten intolerance and celiac diseases, the company said.

For more information, visit www.hygiena.com.