On August 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 it has expanded the access to its PREEMPT CRC registrational clinical trial to enroll patients from nearly any zip code, as part of initiatives to adapt to the COVID-19 pandemic in the U.S (Press release, Freenome, AUG 26, 2020, View Source [SID1234564060]). All eligible 45- to 85-year old patients in the continental U.S. can participate in the clinical study validating Freenome’s multiomics blood test for colorectal cancer (CRC) screening. Freenome is implementing virtual tools, logistics, and communications to enroll patients nationwide in response to the dramatic decline of standard-of-care screening colonoscopies during the global pandemic.
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"The COVID-19 pandemic has posed unique challenges for colon and rectal cancer screening that will have a direct impact on health outcomes," said Gary Reedy, CEO of the American Cancer Society. "Usually, there are 800,000 to 1,000,000 screening colonoscopies per month in the U.S., whereas during the pandemic these numbers have dropped to a fraction of the monthly average. We are concerned that more people will experience poor outcomes and death from colorectal cancer as a result of delaying or foregoing screening, so we encourage people to schedule their screening."
PREEMPT CRC is Freenome’s prospective clinical trial that is enrolling up to 14,000 individuals to validate the company’s multiomics blood test for CRC screening to support approval by the U.S. Food and Drug Administration (FDA). The study includes asymptomatic, average-risk patients between the ages of 45 and 85 who are also undergoing a screening colonoscopy. Patients across the U.S. can participate in the trial with their local physicians and within their local healthcare processes without having to travel to specific trial sites.
"Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death in men and women in the United States," said Michael Sapienza, CEO of the Colorectal Cancer Alliance. "And incidence is 20% higher in African Americans, who have also been more severely impacted by COVID-19. The pandemic has only highlighted the need for more accessible and patient-friendly technologies that could significantly increase the number of screenings for CRC, one of the most preventable cancers if more people participated in early screenings."
"We have adapted our clinical trial during the COVID-19 pandemic to meet the needs of patients, as many elective and diagnostic procedures were placed on hold and pandemic hotspots have shifted around the country," said Freenome CEO Gabriel Otte. "We are grateful for the commitment of the clinical trial collaborators and investigators for working with us to enroll patients to improve accessibility and adherence to cancer screening with a simple blood test."
Today, Freenome also announced a $270 million Series C financing from a range of investors including financial institutions, healthcare companies and cancer organizations, such as the American Cancer Society and the Colorectal Cancer Alliance. The funding will be used to accelerate the PREEMPT CRC clinical trial, fund the company’s product pipeline, and continue building Freenome’s multiomics platform for a range of cancer types, in addition to colorectal cancer.
For more information about the PREEMPT CRC clinical trial or to enroll, please visit www.PREEMPTCRC.com.
About Colorectal Cancer (CRC) and Screening
According to the U.S. Centers for Disease Control (CDC), colorectal cancer (CRC) is the second leading cause of cancer death in the United States of cancers that affect both men and women. Both CRC incidence and mortality have declined steadily over the past 30 years, attributable in part to the increasing percentage of adults aged 50–75 years who are up to date with recommended CRC screening. However, only 68.8% of adults aged 50–75 years were up to date with CRC screening in 2018. A CDC study shows that compliance varies based on income, access to health insurance and other factors, including lack of awareness of the need to be screened, being offered colonoscopy only instead of a choice of tests, fear, expense, inability to take time off work and the perceived undesirable nature of screening tests.1