TEST:

GUARDANT SHIELD

P=N/A, N=500, Recruiting, Milton S. Hershey Medical Center | Trial completion date: Aug 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025

"Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that patient enrollment has begun in the National Cancer Institute (NCI)’s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology. Guardant’s Shield™ MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests—blood tests that can screen for several types of cancer simultaneously—in future randomized controlled trials."

"Guardant Health, Inc...today announced an agreement with the Abu Dhabi Public Health Center (ADPHC) to introduce a non-invasive blood-based screening program for colorectal cancer using Guardant’s Shield test. The agreement was set up through Hikma Pharmaceuticals PLC, a multinational pharmaceutical group and regional partner for Guardant in the Middle East and North Africa, and will be administered by the M42 healthcare system...The Shield test will be provided as part of the ADPHC’s IFHAS comprehensive health screening program and will be available at major healthcare facilities operated by Ambulatory Healthcare Services and M42 sites across Abu Dhabi, Al Ain, and the Al Dhafra region....The blood-based colorectal cancer screening program is expected to screen approximately 10,000 people across Abu Dhabi and surrounding regions in its first year."

First-generation cf-bDNA tests may deliver net benefit or harm, depending on the balance between achieving screening in persons who decline alternatives versus substituting cf-bDNA for more effective alternatives. The Gorrindo Family Fund.

"Guardant Health, Inc...announced the company and its research collaborators will present data supporting the critical role of blood-based testing in increasing overall colorectal cancer (CRC) screening adherence at the American College of Gastroenterology (ACG) 2024 Annual Meeting in Philadelphia, Oct. 25-30, 2024. Guardant and its research partners will share real-world data demonstrating poor patient compliance with repeat stool-based screening....A second presentation will report on the one-year outcomes of individuals tested with Guardant’s Shield blood test for CRC screening in the ECLIPSE study to understand the implications of 'false positive' results."

"Guardant Health, Inc...today announced that its Shield blood test, recently approved by the U.S. Food and Drug Administration (FDA), is now covered by Medicare and is commercially available in the U.S. as the first FDA-approved blood test for primary colorectal cancer (CRC) screening...The Centers for Medicare & Medicaid Services (CMS) now covers the Shield test based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests (NCD 210.3). The test is covered once every three years for eligible Medicare beneficiaries....Commercial insurance coverage for patients eligible for CRC screening will continue to expand pending future review and inclusion in guidelines by the American Cancer Society and the U.S. Preventive Services Task Force (USPSTF)."

"Guardant Health, Inc...announced the U.S. Food and Drug Administration (FDA) has approved the company’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. It is the first blood test to be approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage....The FDA decision follows a strong recommendation for approval by an Advisory Committee panel in May 2024. The approval was based on results of ECLIPSE, a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults."

"Guardant Health...will present data from 16 studies highlighting the role of Guardant blood tests and real-world data in advancing precision oncology and cancer screening at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, May 31-June 4 in Chicago...Featured presentations will share data supporting the utility of therapy response monitoring with circulating tumor DNA (ctDNA) using Guardant Infinity and the use of the GuardantINFORM clinical-genomic database to characterize drivers and resistance mechanisms and their association with real-world outcomes in a variety of solid tumor types. Additional studies will present data supporting the application of genomic and epigenomic biomarkers in areas such as minimal residual disease detection and cohort characterization."

"Guardant Health, Inc...announced the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA)’s Medical Devices Advisory Committee has strongly recommended FDA approval of the company’s Shield™ blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease."

"Guardant Health, Inc...announced that Nasdaq has temporarily halted trading of the company's stock...The Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee will meet today to review the premarket approval (PMA) application for Shield, Guardant Health’s blood test to screen for colorectal cancer in average-risk adults...The panel meeting is scheduled to begin at 9:30 a.m. ET....FDA advisory committees provide independent expert advice and non-binding recommendations to the FDA on certain products to help the agency make sound decisions based on the available science."

"Guardant Health, Inc...announced it will present data from two real-world studies at the 2024 Digestive Disease Week (DDW) meeting in Washington, DC, highlighting the value of the company’s Shield test in colorectal cancer (CRC) screening....The full abstracts for Guardant Health and a list of all abstracts being presented at the meeting will be available at the DDW website."

"Guardant Health, Inc...today announced the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration Medical Devices Advisory Committee is scheduled to review the premarket approval (PMA) application for the company’s Shield blood test for colorectal cancer (CRC) screening on Thursday, May 23, 2024....'We look forward to discussing with the FDA Advisory Committee and its panel of experts the clinical data from our ECLIPSE study and the potential for the Shield blood test to overcome the barriers of current screening methods and offer a new, more convenient screening option that will detect colorectal cancer in the early stages, when it is most treatable.'"