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At Fluxion, we’re passionate about delivering cell-based and cell-free solutions that facilitate the transformation of research discoveries into new ways to diagnose and treat patients. By characterizing molecular and cellular mechanisms of disease, Fluxion’s platforms help bridge the translational medicine gap, enabling rapid advances in disease research, drug discovery, and the development of diagnostic tests.

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FLUXION BIOSCIENCES RECEIVES FOUNDATIONAL PATENT COVERING NGS LIQUID BIOPSY APPROACH

Patented ERASE-Seq approach delivers ultra-high sensitivity somatic mutation detection using molecular amplification pools (MAPs) and background error correction

Alameda, CA, December 3, 2019 - Fluxion Biosciences announced today a foundational patent has been issued for its ERASE-Seq technology, US patent 10,294,518, ‘Methods and Systems for Ultra-sensitive Detection of Genomic Alterations’. The ERASE-Seq technology and testing approach leverage inter-sample statistical analysis, rather than tracking of individual molecules, to dramatically increase sensitivity and eliminate false positives.

Liquid biopsies offer the potential to improve treatment of cancer by providing affordable, non-invasive detection of actionable cancer mutations from a blood sample. However, the relative abundance of cancer DNA in blood is extremely low, below the sensitivity threshold of standard sequencers. Approaches such as molecular barcodes have resulted in improved performance; however, high sensitivity and, importantly, high specificity have been difficult to achieve at allele frequencies between 0.1-0.5%, a critical region for somatic cancer variant detection in liquid biopsies.

“We’re delighted that the novelty of Fluxion’s core technology powering ERASE-Seq bioinformatics has been recognized by the US Patent Office. Existing approaches necessitate the use of molecular barcodes (unique molecular IDs, or UMIs) which have several limitations”, states Dr. Cristian Ionescu-Zanetti, CTO. “ERASE-Seq circumvents key limitations of UMI technology, such as tagging efficiency and barcode errors, while delivering superior performance in the critical 0.1-1% allele frequency range. This is a uniquely versatile approach, applicable to almost all existing targeted sequencing panels.”

The ERASE-Seq bioinformatic solution has been commercialized for a number of targeted gene panels available from Fluxion, as well as third-party providers such as Swift Biosciences and Illumina. ERASE-Seq can be adapted to dramatically increase the sensitivity of any standard targeted panel, down to the low input DNA quantities characteristic of cfDNA samples from cancer patient blood samples.

About Fluxion Biosciences

Fluxion’s pioneering liquid biopsy technologies include the IsoFlux CTC Liquid Biopsy System, Spotlight™ Oncology Panels for ultra-sensitive mutation detection from cfDNA, and the ERASE-Seq variant caller for liquid biopsies. Fluxion’s technologies are used globally by leading cancer centers developing new tests for early cancer detection and patient monitoring. For more information about Fluxion Biosciences’ liquid biopsy capabilities, visit http://liquidbiopsy.fluxionbio.com.