Iron Horse Diagnostics, Euroimmun AG Partner on First-to-Market ALS Diagnostic Test

Iron Horse Dx has signed a nonexclusive license agreement with Euroimmun Medizinische Labordiagnostika AG (Lübeck, Germany) to launch the first biological diagnostic test for amyotrophic lateral sclerosis (“ALS”), more commonly known as Lou Gehrig’s disease.
 
ALS is a progressive neurological disease with an average life span of three to five years from diagnosis. Current clinical methods to diagnose ALS can take over one year, leaving patients helpless to act during the early stages of the disease and limiting their ability to join clinical trials of newer disease modifying therapeutics in drug development.
 
The ALS Test is based on more than 20 years of research by Dr. Robert Bowser, president of Iron Horse Dx, and is shown to be 93 percent accurate (positive predictive value = 0.939 and negative predictive value = 0.917), providing a first biological based diagnostic test for ALS. “We have come a long way in researching and understanding the complexities of ALS over the past few years,” said Bowser. “The ALS Test will benefit patients by aiding physicians to make a more rapid and definitive diagnosis, allowing more efficient clinical trials in particular in early phases of ALS, thereby shorting the time to finding a cure.”
 
Under the terms of the license agreement, Euroimmun AG, with more than 2,100 employees worldwide and distribution into over 130 countries, will have the nonexclusive rights to launch the ALS diagnostic assays as a CE marked product, while Iron Horse is launching the assay in the United States as a laboratory-developed test in CLIA-certified laboratories. Iron Horse is working in close collaboration with the ALS Association and has received funding from the National Institutes of Health, Biogen and the state of Arizona.
 
“Euroimmun has extensive expertise in the fields of neuroimmunology. Together with Iron Horse Dx, we were able to develop this novel CE-marked assay for neurofilament heavy chain, complementing our portfolio of neurological diagnostics,” said Dr. Winfried Stöcker, president and managing director of Euroimmun. “With the launch next month, the test will be distributed worldwide to reach as many people as possible with this devastating disease.”
 
Iron Horse Dx was formed to create breakthrough diagnostic tests in neurologic disorders with high-unmet medical need. The company was founded in 2012 and has received funding from The National Institutes of Health, The ALS Association, The Arizona Commerce Authority and Biogen to finalize development and commercialize the ALS Test. The ALS assay has been validated in two CLIA labs and results published in numerous scientific publications. Iron Horse will release the ALS Test in the United States this year. Iron Horse’s neurologic diagnostic innovations also include a simple blood based TBI/concussion diagnostic test set for release in 2018 as well as biomarker assay services for U.S. companies.
 
Euroimmun AG produces test systems and automation solutions for medical laboratory diagnostics. The company was founded in September 1987, and has 12 international subsidiaries, covering roughly 35 countries. Overall, Euroimmun distributes its products in about 130 countries in Europe, America, Asia, Australia and Africa.