Norgen Biotek Corp. Announces Supply Agreement with Biodesix Enabling the First EML4-ALK Liquid Biopsy Test with Results in 72-Hours

Norgen Biotek Corp., an innovative Canadian biotechnology company focusing on advancing powerful tools for DNA, RNA and protein stabilization and purification, today announced the signing of a supplier agreement with Biodesix, Inc. to supply novel sample preparation products based on Norgen Biotek’s proprietary purification technology. Biodesix, Inc. is a U.S.-based company that discovers and commercializes diagnostic cancer blood tests that help patients and their doctors make more informed decisions about treatment based on a patient’s unique molecular profile.

Up to 80% of cancer patients will not have mutation results available at their initial oncology consult, which can delay treatment decisions. Knowing targetable mutations quickly can result in the patient being treated sooner. A blood test with 72 hrs time to results can enable oncologists with the critical information to treat the right patient with the right therapy at the right time.

“The Biodesix – Norgen Biotek agreement is an example of Biodesix’ commitment to bringing clinically useful blood-based diagnostics to the market,” said Gary Pestano, vice president of product development and operations.  Biodesix. “Earlier this year, Biodesix launched GeneStrat EML4-ALK, the first liquid biopsy test detecting EML4-ALK gene rearrangements that provides results within 72 hrs. The test includes Norgen’s innovative best-in-class sample preparation products as part of the assay workflow. Quickly identifying which patients with non-small cell lung cancer (NSCLC) harbor this rearrangement can result in treatment with ALK inhibitor therapy sooner.”

Dr. Yousef Haj-Ahmad, President of Norgen Biotek Corp, states, "Sample preparation using Norgen’s kits is an ideal fit for Biodesix’ innovative blood tests in oncology, and we are very excited to move forward in this partnership with Biodesix. Biodesix is putting exciting new tests into clinicians’ hands that are advancing the diagnosis, treatment and monitoring of cancer. Norgen has a proven track record for best-in-class products for RNA, DNA and protein stabilization and sample preparation, and we are confident that this agreement will foster a long and mutually beneficial relationship between Norgen and Biodesix."

The GeneStrat blood test is run in Biodesix’ CLIA-certified lab and is used by oncologists across the US. An abstract describing validation of the test, “Diagnostic test system for sensitive, specific and reproducible detection of EML4-ALK RNA fusion transcripts in the blood of patients with NSCLC” was selected for oral presentation at the upcoming AACR Annual Meeting in New Orleans on April 17^th. The EML4-ALK test will also be included as part of an oral presentation at the 2016 Molecular Medicine Tri Conference on March 11^th entitled “Blood Testing for Actionable Variants in NSCLC Patients by ddPCR: A CLIA Lab Experience”.

About Norgen Biotek Corp.:Norgen Biotek Corp., an ISO 15189:2007, ISO 13485:2003 and ISO 9001:2008 registered company, is a privately-held Canadian biotech company committed to providing innovative products and services for the life sciences and pharmaceutical industry. Norgen is applying its proprietary technologies to develop best-in-class products for the stabilization and purification of nucleic acids and proteins, as well as for molecular diagnostics. Detailed information about the company is available at www.norgenbiotek.com or contact Dr. Yousef Haj-Ahmad, President & CEO, Norgen Biotek. Phone: (905) 227-8848; email: yha@norgenbiotek.com.

About Biodesix:
Biodesix^® is a molecular diagnostics company advancing the development of innovative blood-based tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic blood tests, including GeneStrat™ and VeriStrat^®, that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of precision medicine, Biodesix is developing new blood tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.