HTG, Illumina Expand IVD Test Collaboration to Autoimmune, CV, Fibrosis Disorders

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HTG Molecular Diagnostics has expanded a 4½-year-old agreement with Illumina allowing for development of in-vitro diagnostic (IVD) test kits for use with the companies’ technologies beyond oncology, to now include autoimmune, cardiovascular, and fibrosis disorders and diseases. The companies have agreed to develop tests for use with HTG EdgeSeq molecular profiling technology (pictured) and Illumina’s MiSeqDx sequencer. [HTG Molecular Diagnostics]

HTG Molecular Diagnostics said today it has expanded a 4½-year-old agreement with Illumina allowing for development of in-vitro diagnostic (IVD) test kits for use with the companies’ technologies beyond oncology, to now include autoimmune, cardiovascular, and fibrosis disorders and diseases.

The value of the amended agreement was not disclosed.

HTG’s IVD Test Development and Component Supply Agreement with Illumina enables development and commercialization of nuclease-protection-based RNA or DNA profiling tests for use with HTG EdgeSeq molecular profiling technology and Illumina’s MiSeqDx sequencer.

“This amendment highlights our commitment to developing molecular diagnostic tests which advance precision medicine, not only in oncology, but in other critical fields,” John Lubniewski, HTG’s President and CEO, said in a statement.

He cited a potential sizeable market for the additional tests, noting that according to the American Autoimmune Related Diseases Association, over 50 million Americans currently live with an autoimmune disease, with over 100 separate autoimmune diseases recognized by the group.

“Biomarker-driven autoimmune drug development has recently become a focus of many biopharmaceutical companies, which creates a potential opportunity for HTG to partner with these companies in creation of a companion diagnostic leveraging HTG’s EdgeSeq technology and Illumina’s sequencing technology,” Lubniewski added.

Byron Lawson, HTG’s SVP, Pharma Business Unit, cited an earlier HTG announcement that the company is developing a 2,000+ gene expression assay for molecular profiling both liquid and tissue biopsies in autoimmune diseases that is expected to be available as a Research Use Only assay in 2019

“We are very excited about this new comprehensive autoimmune assay, which will be available for potential biomarker discovery with liquid biopsy as the primary sample type,” Lawson stated. “Early indications from biopharmaceutical companies of the need for biomarker-driven autoimmune development have led to the expansion of our agreement with Illumina, which we believe provides the foundation for potential development of one or more such autoimmune companion diagnostic assays.”

The companies signed their original agreement in October 2014, and amended it in June 2017 to extend the agreement term and increase the number of IVD test kits that may be developed for use with Illumina sequencing technology.

Under the 2017 amended and restated agreement, HTG agreed to pay Illumina up to $0.6 million tied to achieving regulatory milestones relating to the IVD test kits, and a single digit percentage royalty on net sales of any IVD test kits that HTG commercializes through the agreement.

“None of these regulatory milestones have been reached through December 31, 2018,” HTG disclosed in its Form 10-K annual report for 2018, filed March 7.

However, HTG paid Illumina $12,500 last year, and $50,000 in 2017, toward costs of IVD test development plans submitted by HTG to Illumina in accordance with the 2017 agreement.

The 2017 amendment also called for a 10-year agreement expiring in May 2027—though Illumina is not obligated to notify HTG of changes in its products that may affect its IVD test kits after May 31, 2023. Those terms remain in effect under the new agreement.

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