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MDx/CDx Focus: Abbott, Epizyme Advance CDx for Novel Leukemia Drug; Segeene, Selventa Develop MDx

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Epizyme, Abbott Developing CDx for Mixed Lineage Leukemia Drug

Epizyme and Abbott announced they are working together to develop a molecular diagnostic to accompany its investigational treatment for mixed lineage leukemia, EPZ-5676.

The drug, EPZ-5676, inhibits DOT1L histone methyltransferase. MLL, a subtype of acute myeloid leukemia and acute lymphoblastic leukemia, is caused by a translocation involving the MLL gene.

"Abbott will utilize its proprietary fluorescence in situ hybridization technology to design a test to detect MLL genetic alterations that lead to the oncogenic function of DOT1L," Epizyme said in a statement. In turn, Epizyme will use Abbott's test to identify which patients will respond to EPZ-5676.

The partners did not reveal the specific gene alteration the companion test would gauge in MLL patients.

MLL is a more aggressive form of acute leukemia, and between 5 percent and 24 percent of patients survive for five years. Currently there are no approved treatments for MLL.

This is the second companion diagnostic deal for Epizyme. Earlier this year, the company inked a deal with Roche to develop a PCR test that can identify lymphoma patients with mutations in the EZH2 gene who are likely responders to an EZH2 inhibitor the company is developing with Eisai.


Seegene, Selventa to Develop MDx in Underserved Markets

Seegene and Selventa announced this week that they would together develop molecular tests that can help personalized treatments for autoimmune diseases, cancer, and infectious diseases, markets that the companies feel have unmet needs.

Under the partnership, the companies would advance molecular tests with the help of Selventa's Systems Diagnostics multi-omic analytics platform and Seegene’s TOCE and DPO multiplex PCR technology. SysDx analyzes patients' genomic, epigenomic, transcriptomic, proteomic, metabolomic, and electronic medical record information to identify biomarkers linked to diseases and treatment response. Seegene’s qTOCE technology can operate on qPCR platforms and provide real-time detection and quantification of as many as seven targets in a single channel.

"Seegene’s world-class detection technology and assay development in combination with our SysDx platform can result in a wide range of novel [tests] with high clinical utility," David de Graaf, Selventa CEO, said in a statement.

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