Grail is back in Illumina’s fold after the sequencing giant agreed in September to pay $8 billion in cash and stock for the liquid biopsy company that uses tumor DNA present in blood to screen for early-stage cancers, when treatment outcomes are better. Grail spun out of Illumina in 2016 with the support of investors including Arch Venture Partners, Bezos Expeditions and Bill Gates. The aim was to develop a technology that would combine ultrasensitive DNA sequencing and machine learning into non-invasive blood tests to detect cancers earlier, even in people without symptoms. Grail invested over $1 billion to fund the Circulating Cell-free Genome Atlas Study, which would recruit thousands of participants, some with newly diagnosed cancers and some without, and was aimed at comparing tumor DNA profiles in blood and building a genomic picture of early-stage cancer. The company published results showing its cancer screening blood test could identify more than 50 cancers types across all growth stages. The diagnostic used targeted methylation in circulating DNA to detect and evaluate tumors and their tissue of origin with >90% accuracy and a single false positive rate of <1%.The Illumina spinout expects to launch in 2021 a multicancer, laboratory-developed test from blood, for use in asymptomatic individuals. Following the acquisition, Grail will operate as a stand-alone company within Illumina.
In August, the US Food and Drug Administration approved a liquid biopsy diagnostic test that uses next-generation sequencing to identify patients with EGFR gene mutations in metastatic non-small-cell lung cancer (NSCLC). The assay, developed by Guardant Health, detects mutations in 55 tumor genes simultaneously and identifies patients who will benefit from the drug Tagrisso (osimertinib), approved for NSCLC. Also in August, the agency approved Foundation Medicine’s liquid biopsy next-generation sequencing-based test as a companion diagnostic to identify patients with BRCA1- or BRCA2-mutated prostate cancers, who may benefit from treatment with Rubraca (rucaparib) from Clovis Oncology.
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