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Roche Dx Inks Manufacturing Deal with Ionian for Nucleic Acid Amplification Tech


Roche Diagnostics has signed an agreement with Ionian Technologies that gives it exclusive manufacturing rights for certain applications of Ionian's proprietary isothermal nucleic acid amplification technology.

Under the terms of the agreement, Roche "will identify new applications and customers" for Ionian's Nicking Enzyme Amplification Reaction, or NEAR, technology. Roche will "bring these opportunities to Ionian," which will develop assays based on the NEAR platform, and then Roche will have exclusive manufacturing rights for any commercialization opportunities that arise from the collaboration.

The collaboration "allows Ionian to continue to focus on its core strengths, including technology and assay development, while leveraging the business development, sales, and manufacturing expertise of Roche," Andrew Miller, Ionian CEO, said in a statement.

Ionian said that its NEAR assays are able to detect both DNA and RNA from bacterial or viral pathogens in less than 10 minutes with the same sensitivity as PCR. The company said that the technology can also handle raw or unpurified samples, making it "ideally suited for point-of-care and point-of-use settings."

The technology is based on the rapid detection of small DNA or RNA fragments that are generated directly from the target nucleic acid. For the detection of RNA targets, no separate cDNA synthesis step is necessary, the company said.

Privately held Ionian was founded in 2000 with the goal of commercializing the NEAR technology for the rapid detection of nucleic acids in several fields, including human in vitro diagnostics, food safety, biodefense, agriculture, and veterinary applications.

The company has several contracts with the Defense Advanced Research Projects Agency and the Department of Homeland Security to develop biothreat detection assays systems. The company also has an agreement with EnviroLogix of Portland, Maine, that gives that firm exclusive rights to develop, manufacture, and sell tests based on the NEAR technology for the agricultural, plant pathogen, and veterinary markets.

Last year, Ionian received a $665,000 grant from the Bill & Melinda Gates Foundation to develop a rapid point-of-care diagnostic test based on NEAR to detect chlamydia, gonorrhea, and tuberculosis.