QIAGEN and BioHelix Enter Into Licensing Agreement

Helicase-dependent isothermal DNA amplification system provides new assay technology capabilities for QIAGEN’s assay automation platforms

Venlo, The Netherlands, and Beverly, Massachusetts, – April 30, 2008 – QIAGEN (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA) and privately held BioHelix have announced today that they have entered into a non-exclusive worldwide license and supply agreement for BioHelix’s proprietary Helicase Dependent Amplification technology (HDA). HDA is a versatile assay technology to detect and analyze biological target molecules such as DNA and RNA by amplifying target specific genetic information with the highest level of sensitivity and specificity. Financial terms were not disclosed.

This licensing agreement adds a further amplification technology to QIAGEN’s broad intellectual property estate of amplification and assay technologies that includes numerous PCR and PCR-similar technologies as well as technologies such as rolling circle amplification (RCA) and whole genome/transcriptome amplification. These technologies are selected depending upon aspects such as the targeted setting, system and performance.

Unlike conventional amplification technologies such as the polymerase chain reaction (PCR), which requires thermocycling, HDA works at a constant temperature, eliminating the need for complex and costly instrumentation. In addition HDA technology offers a simple reaction workflow and a user-friendly assay design process. Two primers are used to flank the DNA fragment to be amplified, thereby allowing simple and rapid development of new singleplex and/or multiplex assays for use in research, pharmaceutical development, applied markets or molecular diagnostics.

HDA is compatible with multiple detection technologies including qualitative or quantitative fluorescent detection technologies, and also with instrumentation designed for use with real-time PCR. The technology is also compatible with QIAGEN’s suite of next-generation Hybrid Capture™ detection platforms, which includes an ultra-high throughput instrument designed for use with assays including QIAGEN’s next generation HPV assay to test for human papillomavirus, the primary cause of cervical cancer. By combining the HDA platform with other assay technologies including QIAGEN’s hybrid capture technology, the most important tests in women’s health, human papillomavirus (HPV), chlamydia trachomatis (CT) and neisseria gonorrhoeae (GC) can be run using a single instrument and a single specimen.

Furthermore, HDA has shown potential for the development of simple, portable DNA diagnostic devices to be used in the field or at the point-of-care.

“We are excited about the opportunities coming along with HDA technology,” said Jim Godsey, Senior Vice President Research & Development North America for QIAGEN. “The ability to amplify DNA or RNA using an isothermal amplification system opens up a wide field of new assays in many areas, in particular in human molecular diagnostics and applied testing.”

“We are extremely excited about the global reach and development capabilities of QIAGEN as a partner. This license validates the utility of our technology while further enhancing our plans for growth,“ said Dr. Huimin Kong, inventor of HDA and CEO of BioHelix Corporation.


QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN’s assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 2,700 people in over 30 locations worldwide. Further information about QIAGEN can be found at www.qiagen.com.

About BioHelix Corp.:

BioHelix Corporation, a privately held diagnostics company located in Beverly, Massachusetts, specializes in the development of next-generation diagnostic solutions and nucleic acid tests based upon their isothermal HDA platform for infectious diseases, such as Methicillin-resistant Staphylococcus aureus (MRSA), Herpes Simplex Virus, and for genetic diseases. The company’s mission is to improve the quality of healthcare through the development of simple molecular tests for the near patient setting, wherein rapid solutions are necessary for prompt medical intervention. Additional information about BioHelix Corporation is available at www.biohelix.com.

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