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

Issue link:

Contents of this Issue


Page 7 of 51

6 Clinical OMICs March/April 2019 News A generation after heading the Human Genome Project, David J. Galas, Ph.D., established a research lab at the Keck Graduate Institute in Claremont, CA that focused on developing isothermal technology for amplifying nucleic acids as an alternative to PCR. He also founded a spinout company focused on commercializing the resulting assays. The Keck spinout, Ionian Technologies, succeeded more than a decade ago in achieving detection of infectious dis- eases within minutes through rapid amplification of small samples of short DNA or RNA fragments. The technology attracted the interest of Alere, which acquired Ionian in 2010 and began commercializing the assays four years later. Today, Galas represents roughly three dozen former Ionian shareholders who have spent nearly two years wag- ing a legal battle to secure $30 million in milestone payments they contend are owed to them by Alere and its successor company, Abbott. The case is pending in Superior Court of California, County of San Diego, where it is headed for trial in June, after Alere tried, but failed, to have it dismissed. Alere has argued that the Ionian shareholders had not ful- filled the terms of the companies' merger agreement, and has accused Galas of breaching the accord—contentions that Galas denied in an interview. At the center of the legal dispute is the Ionian-developed isothermal technology, which was designed to deliver rapid detection of infectious diseases through quick amplification of small samples of short DNA or RNA fragments. The iso- thermal tech was developed by Ionian researchers who ear- lier worked for Galas' lab at Keck. Isothermal Reactions Ionian was founded in 2000. Three years later, Galas led a team of researchers in publishing a paper in PNAS detailing the technology, "Isothermal reactions for the amplification of oligonucleotides." The team noted that their isothermal reactions for ampli- fying DNA offered advantages over rolling-circle ampli- fication and especially the much more widely used PCR: namely, no more need for a temperature cycling protocol to achieve amplification—which effectively limited the rate of amplification to the temperature cycling schedule—and the ability to achieve amplification above the maximum two- fold amplification achievable in each cycle. "The robustness, speed, and sensitivity of the exponen- tial reaction suggest it will be useful in rapidly detecting the presence of small amounts of a specific DNA sequence in a sample, and a range of other applications, including many currently making use of the PCR," Galas and colleagues concluded. Also in 2003, Galas secured a $489,000 grant from the Defense Advanced Research Projects Agency (DARPA) to develop the rapid-detection technology, then known as the Handheld Isothermal Silver Standard Sensor. "[DARPA] was interested in infectious agents that were biological threats, so we never really got down to looking at just trying to actually develop…specific assays," Galas noted. "We looked at a number of bacterial threat agents or their surrogates in bacterial sequences, to just show we could mutually—or Ionian could—actually detect those." "The original focus was on biological threat agents. But it was clear that in the long run, Ionian would need to develop commercial products for the healthcare market, and diag- nostics for more common infectious diseases was clearly what was called for." Amplification Litigation Human Genome Project Leader Among Shareholders in Legal Wrangle Over Milestones for PCR Alternative By Alex Philippidis DNY59 / E+ / Getty Images

Articles in this issue

Links on this page

Archives of this issue

view archives of Clinical OMICS - MAR-APR 2019