Freenome Announces Initiation of the PREEMPT CRC Clinical Trial, a Registrational Study for the Early Detection and Prevention of Colorectal Cancer Using a Multiomics Blood Test

On May 26, 2020 Freenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, reported that several new developments: initiating its PREEMPT CRC clinical trial; adding Gary Reedy, CEO of the American Cancer Society, to the Board of Directors; and appointing William Quirk as the Chief Financial Officer (Press release, Freenome, MAY 26, 2020, View Source [SID1234558491]).

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"Following strong data presented at ASCO (Free ASCO Whitepaper)-GI, which demonstrated 91% sensitivity (94% in Stage I/II patients) with 94% specificity for colorectal cancer (CRC), we are initiating the pivotal trial for our blood-based CRC test," said CEO, Gabriel Otte. "More recent studies using our multiomics platform have revealed that different biomarkers are required for the detection of precancerous polyps versus CRC, and the availability of a blood test with adenoma detection rates as good or better than any known fecal test will meaningfully improve patient adherence and revolutionize CRC screening," added Chief Medical Officer, Dr. Girish Putcha.

PREEMPT CRC is Freenome’s prospective clinical trial that will enroll 14,000 individuals to validate its multiomics blood test for CRC screening and FDA approval. The study will include asymptomatic, average-risk patients between the ages of 45 and 85 undergoing a screening colonoscopy.

"In conjunction with the initiation of PREEMPT CRC, we are delighted that Gary Reedy has joined our Board of Directors as an observer," said Mr. Otte. "Gary’s 40+ years of fighting cancer makes him an ideal partner in our mission of making cancer screening tests accessible for everyone and improving patient adherence to cancer screening guidelines."

"It is incredibly important to improve CRC screening rates as much as possible," said Reedy. "The National Colorectal Cancer Roundtable has set a goal of 80% screening adherence in every community. If Freenome’s multiomics approach can help us achieve that goal, it would be wonderful. This is why our BrightEdge impact fund has chosen to invest in Freenome’s work."

Mr. Reedy became Chief Executive Officer of the American Cancer Society in April 2015, but his work with the organization began more than 20 years ago, when he first became a volunteer leader with the organization. Prior to his work with the ACS, Mr. Reedy had a distinguished 37-year career as a healthcare business and advocacy leader, most recently as Worldwide Vice President, Government Affairs and Policy, at Johnson & Johnson. Previously, Mr. Reedy held senior leadership positions with SmithKline Beecham, Centocor, and Johnson & Johnson. Mr. Reedy is a graduate of Emory & Henry College and holds an honorary Doctor of Humane Letters degree from Arcadia University.

"We are also happy to announce Bill Quirk has joined Freenome as our CFO," said Mr. Otte. "Bill’s extensive background covering the diagnostics industry for nearly 20 years, including his experience in helping growth companies raise capital, makes him a great addition to our team."

"Freenome has the rare combination of exceptional science and a mission-driven culture, which positions us to have a profound impact on human health," said Mr. Quirk. "I’m excited to join Freenome at such a meaningful point in our development."

Prior to joining Freenome, Mr. Quirk served as a managing director in the equity research division of Piper Sandler, a full-service investment bank. Mr. Quirk received a Bachelor’s of Business Administration from Saint Norbert College, an MBA from the University of Minnesota’s Carlson School of Management, and holds the CFA designation.