On January 5, 2023 QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) reported an exclusive strategic partnership with California-based population genomics leader Helix to advance companion diagnostics for hereditary diseases (Press release, Qiagen, JAN 5, 2023, View Source [SID1234625909]).
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As the development of precision medicines accelerates, so does the need for companion diagnostics devices and tests detecting clinically relevant genetic abnormalities. These diagnostics help guide clinical decision-making by identifying patients most likely to benefit – or be at increased risk – from a particular therapeutic product. Principally used in oncology to date, companion diagnostics that employ whole exome sequencing are widely believed to have great potential in hereditary disease areas such as cardiovascular, metabolic, neuro-degenerative, and auto-immune diseases.
Under the agreement announced today, QIAGEN will be the exclusive marketing and contracting partner in the U.S. for Helix’s companion diagnostic services. The partnership will leverage the Helix Laboratory Platform, which was granted the first-ever U.S. Food & Drug Administration de novo class II authorization for a whole exome sequencing platform. This brings a new innovative solution to biopharmaceutical customers in support of hereditary disease therapies, complementing solutions both companies already provide such as Helix’s population genomics programs and QIAGEN’s diagnostic expertise, QIAseq Human Exome Kits and global reach supporting research initiatives outside the U.S.
A pioneer in precision medicine, QIAGEN has more than 30 master collaboration agreements with global pharmaceutical and biotechnology companies to develop and commercialize companion diagnostic tests for their drug candidates. QIAGEN’s companion diagnostic offerings encompass technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) and digital PCR (dPCR), sample types from liquid biopsy to tissue, and disease areas from cancer to Parkinson’s – including 11 FDA-approved PCR based companion diagnostics and a collaboration with Neuron23 announced in September 2022 to develop an NGS-based companion diagnostic for a novel Parkinson’s disease drug.
"This partnership represents another step toward bringing the power of companion diagnostics to hereditary diseases by powering Helix’s leading products with QIAGEN’s extensive pharma and biopharma relationships, NGS capabilities, and global regulatory expertise," said Thierry Bernard, Chief Executive Officer of QIAGEN. "Access to a genomic database can help researchers find patients with particular biomarker signatures almost instantaneously, making trial recruitment a matter of months instead of years."
"Helix’s technology and regulatory capabilities coupled with QIAGEN’s well-established worldwide companion diagnostic development capabilities results in a powerful partnership that will allow us to expand critical access to genomic testing for both patients and providers working daily to fight life-threatening conditions," said Helix CEO and Co-Founder, James Lu, MD, PhD. "QIAGEN’s mission to fill the clinical gap for patient access and provide technology platform options to address the needs of physicians to target treatment with genomic medicine is well in line with our mission."
Helix has built an end-to-end platform that enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Helix has partnered with leading health systems to enable population genomics programs of at least 100,000 patients each across the U.S. These programs dramatically accelerate patient identification and recruitment for clinical trials in hereditary diseases such as Parkinson’s, cardiovascular or inflammatory disease like non-alcoholic steatohepatitis (NASH), power real-world data (RWD) or real-world evidence (RWE) services and insights, and bring deep genetic expertise and methodologies to examine sub-cohorts within both drug discovery and a clinical trial.