GSK and Flagship Pioneering Announce Strategic Collaboration to Develop Up to 10 Transformative Medicines and Vaccines; FDA Approves First Blood Test for Colorectal Cancer Screening

Jul 30, 2024 07:29 CST Updated 07:30

Guardant Health

Early Cancer Screening Medical Technology Researcher and Precision Oncology Researcher

GSK

Pharmaceutical R&D Manufacturer

▎WuXiEdited by Kant Content Team

FDA Approves Blood Test for Colorectal Cancer

Guardant Health today announced that the U.S. FDA has approved the company's Shield blood test for screening in adults aged 45 and older with an average risk of developing colorectal cancer (CRC). The press release noted,This is the first blood test approved by the FDA as a primary screening option for colorectal cancer., which means that healthcare providers can offer Shield tests just like other non-invasive screening methods listed in the screening recommendation guidelines. Industry media STAT stated that this isMajor Advances in Liquid Biopsy.

Colorectal cancer is highly curable if detected early. The five-year relative survival rate is 91% when colon cancer is discovered at an early stage before it has spread; if the cancer has metastasized to distant parts of the body, the five-year relative survival rate drops to 14%.

The CRC screening rate in the United States is only about 59%, with more than one-third of Americans who are eligible for screening not completing CRC screening, typically because other available screening options (such as colonoscopy or stool-based tests) are considered invasive, unpleasant, or inconvenient.

The FDA approval was based on the results of the ECLIPSE study, a registrational study involving more than 20,000 patients that evaluated the performance of the test in detecting CRC among adults at average risk. The study aimed to reflect the diverse population of the United States and was conducted across over 200 clinical trial sites in 37 states. Results of the study, published in the New England Journal of Medicine on March 14, 2024, showed,Shield has a sensitivity of 83% for detecting CRC and a specificity of 90% for detecting advanced tumors.This performance falls within the sensitivity range of non-invasive screening methods currently recommended by guidelines, with an overall CRC sensitivity range of 74% to 92%.

GSK and Flagship Pioneering Collaborate to Develop Up to 10 Innovative Drugs and Vaccines

GSK and Flagship Pioneering Announce Collaboration to Discover and Develop Transformative Medicines and Vaccines, Initially Focusing on Respiratory and Immunology

In the early stage of the collaboration, GSK and Flagship will provide up to $150 million in initial funding to support the exploratory research phase, with the aim of identifying the most promising concepts for further research and development. The goal of the collaboration is to discover up to 10 innovative drugs and vaccines, with GSK granted exclusive options for each project for further clinical development. Under the terms of the agreement, Flagship and its bioplatform companies are eligible to receive up to $720 million in upfront research, development, and commercial milestone payments from GSK.

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References:

[1] GSK and Flagship Pioneering partner to discover novel medicines and vaccines. Retrieved July 29, 2024, from https://www.prnewswire.com/news-releases/gsk-and-flagship-pioneering-partner-to-discover-novel-medicines-and-vaccines-302208162.html

[2] Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening. Retrieved July 29, 2024, from https://www.businesswire.com/news/home/20240725240089/en/Guardant-Health%E2%80%99s-Shield%E2%84%A2-Blood-Test-Approved-by-FDA-as-a-Primary-Screening-Option-Clearing-Path-for-Medicare-Reimbursement-and-a-New-Era-of-Colorectal-Cancer-Screening

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