blood cells grail

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Elizabeth Mansfield, current head of the US Food and Drug Administration personalised medicine group, will be leaving the agency this month to join liquid biopsy startup Grail

Since joining the agency in 2006 Mansfield has led efforts to advance the regulation of precision medicine and next-generation sequencing. As a result of her work more than 20% of all new molecular entities approved by the FDA over the past three years were personalised medicines.

“Dr. Mansfield’s leadership at FDA helped turn personalised medicine from aspiration to reality,” Personalized Medicine Coalition President Edward Abrahams said in a statement. “As director and coordinator of the agency’s manifold personalized medicine programs, she pushed to replace antiquated regulatory policies with smart proactive ones that encouraged innovation while also protecting patients.”

The concept of liquid biopsy – a detailed screening of a patient’s blood to detect early signs of cancer before a patient experiences symptoms – has been around for a while, but Gril are the first company attempting to leverage the technology for early-stage cancer detection.

At Grail Mansfield will become head of regulatory strategy, an exciting development for a company that has already set out an ambitious stall for the coming year. In January the company announced plans for an ambitious $1 billion series B financing round, from a currently undisclosed list of investors. 

Through this funding round Grail will obtain greater independence from parent company Illumina, diluting the sequencing giant’s stake to less than 20%.

Launched in January 2016, GRAIL received $100 million in startup funding from Illumina, Bill Gates, Jeff Bezos’s venture fund, Bezos Expeditions, and Arch Venture Partners. At the time  of the launch, Baselga said “If this pans out, this could be a real game changer.” 

While the company’s technology is still in development – at launch Illumina said the first tests would hit the market by 2019 – Grail recently launched its first major clinical venture to characterise the landscape of cell-free DNA. The Circulating Cell-free Genome Atlas will contribute to the development of the company’s early detection cancer tests.