Clinical OMICS

MAR-APR 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Page 8 of 51 March/April 2019 Clinical OMICs 7 News The technology has since been applied in a line of CLIA-waived, marketed diagnostics designed to detect influenza A and B, respiratory syncytial virus (RSV), and strep A. Alere gained control of the technology when its predecessor company, Inverness Medical Innovations ,acquired Ionian in 2010. 'A Nice Opportunity' "We had talked to a couple of other companies," Galas said. "But Ionian was an extremely small company, and we as a board understood is that if we wanted to actually create FDA-approved products, we were going to have to develop a clinical group and so forth. That would have been grow- ing the company substantially more, which would have required substantial investment. "It seemed like a nice opportunity to get quickly into diagnostics and to also get a yield to the investors," Galas added. Alere commercialized the technology through a line of diagnostics it marketed under the name Alere I, starting with the influenza A and B test, which was initially launched in Europe in 2014. Alere was acquired by Abbott in 2017 for approximately $4.5 billion, following more than a year of legal wrangling after Abbott attempted to end the deal. Since then, Abbott has rebranded the test as ID NOW, part of the Rapid Diag- nostics business of Abbott's Diagnostics segment, which fin- ished 2018 with sales of $2.072 billion. Alere, and its successor company Abbott, have refused to pay the $30 million in milestone payments to Galas and other Ionian shareholders. They took Alere to court in May 2017, five months before Abbott completed the acquisi- tion, contending that Alere breached its 2010 agreement to acquire Ionian. "Alere actually discussed possibly paying us half of the milestone payment, but refused to consider more, and ulti- mately, we then filed the complaint before the actual acquisi- tion of Alere was closed," Galas told Clinical OMICs. "Alere was in the process of being acquired by Abbott when the milestone payment issue came up. Alere did make it clear that whatever we might agree to, that is Alere and the Ionian shareholders, it would have to be approved by Abbott." Abbott representatives at deadline had not responded to queries from Clinical OMICs about the case. Alere Strikes Back Alere responded legally in a cross-complaint filed in Octo- ber 2018, accusing Galas and Ionian's onetime CEO Andrew P. Miller, Ph.D., founder and CEO of NAT Diagnostics, of breaching Alere's merger agreement with Ionian. Alere also accused both men and NAT of unjust enrichment and breaches of California's Uniform Trade Secret Act and (a) The cycle of the synthesis and release of the amplified oligonucleotide is shown schematically. On the upper strand is indicated the recognition site for the enzyme N BstNB (5′-GAGTC-3′) and the specific nicking site four bases downstream on this strand. The oligonucleotide produced is indicated in blue, the primer in green, and the template in red. The lengths of the template and amplified oligo are shown (upper left). (b) The results of a linear amplification reaction where the primer template produces a 12 mer as the full-length product. The primer template was present at 1 μM in a 50-μl reaction (see Materials and Methods), and the yield of the reaction products is shown. The duplex used a top strand (ITAtop) of 16 nucleotides and a bottom strand (NBbt12) of 28 nucleotides that produced a 12 mer. (continued on next page)

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