Guardant Health Stock Price, News & Analysis

Guardant Health (Nasdaq: GH) has announced the commercial availability of its FDA-approved Shield™ blood test in the U.S. as a primary screening option for colorectal cancer (CRC). The test is now covered by Medicare for eligible beneficiaries once every three years. Shield is the first FDA-approved blood test for primary CRC screening, offering a convenient alternative to traditional methods.

Key points:

• 83% sensitivity for CRC detection with 90% specificity for advanced neoplasia
• >90% patient adherence rate
• Outperforms stool-based tests in life years gained and CRC cases averted
• Results available in about two weeks

The launch represents a significant opportunity for Guardant Health and a major step in the fight against colorectal cancer.

Guardant Health (Nasdaq: GH) announced the acceptance of its CAN-SCREEN model for publication in the Journal of Medical Economics. This health outcomes study emphasizes the importance of combining effective screening performance with high patient adherence in colorectal cancer (CRC) screening to optimize health outcomes. Unlike existing models, CAN-SCREEN accounts for both clinical efficacy and real-world adherence in predicting CRC incidence and mortality rates.

The study highlights the potential of Guardant Health's blood-based screening test, Shield™, to reduce CRC-related mortality due to its high adherence rates. The model predicts that integrating this non-invasive test into existing screening programs could significantly reduce CRC-related deaths, especially among previously unscreened populations. Patients screened with blood-based testing are predicted to gain more life years compared to those screened with FIT or mtsDNA tests.

Guardant Health's Shield™ blood test has received FDA approval as a primary screening option for colorectal cancer (CRC) in adults aged 45 and older at average risk. This marks a significant milestone as the first blood test approved for CRC screening that meets Medicare coverage requirements. The test offers an easy and convenient alternative to traditional screening methods, potentially improving CRC screening rates.

Key points:

• Shield demonstrated 83% sensitivity for CRC detection with 90% specificity for advanced neoplasia in the ECLIPSE study
• Over 90% adherence rate in real-world clinical settings
• Aims to address the gap in CRC screening rates, currently at 59% in the U.S.
• Potential to detect more cancers at an early stage when they are more treatable

Guardant Health (Nasdaq: GH), a leading precision oncology company, announced it will release its second quarter 2024 financial results on Wednesday, August 7, 2024, after market close.

The company will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET, accessible via a live webcast on the company’s website.

The webcast will be archived and available for replay after the event.

Guardant Health (NASDAQ:GH) has unveiled a major upgrade to its Guardant360 liquid biopsy test, running on the Guardant Infinity smart liquid biopsy platform. The enhanced test now covers 739 genes, a tenfold increase from its predecessor, and includes all guideline-recommended genomic biomarkers for advanced solid tumors. It offers 10 times higher sensitivity in quantifying tumor burden and can identify emerging biomarkers for precise cancer characterization.

Key features of the upgrade include:

• Broader gene panel coverage
• Analysis of both actionable and emerging biomarkers
• Results delivered in 7-10 days
• Medicare and major private payer coverage
• Improved precision in treatment strategy identification

The test's expansion aims to provide oncologists with a more comprehensive view of cancer, potentially improving patient outcomes through more targeted treatment options.

Guardant Health (NASDAQ:GH), a leader in precision oncology, has appointed Dr. Manuel Hidalgo Medina to its board of directors. Dr. Hidalgo, currently the Chief of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, brings extensive expertise in translational and clinical research, particularly in anticancer drug development. His appointment is expected to contribute significantly to Guardant Health's mission of improving patient outcomes through advanced diagnostics.

Dr. Hidalgo's impressive career includes leadership roles at Beth Israel Deaconess Medical Center, the Spanish National Cancer Research Centre, and the Kimmel Comprehensive Cancer Center. He also serves on the board of Bristol Myers Squibb, further enhancing his industry insights.

Guardant Health has launched an upgraded version of its Guardant360 TissueNext test, which now identifies 498 genes or cancer biomarkers. This expanded gene panel helps oncologists find more targeted therapies for patients with advanced cancer. Additionally, operational improvements have streamlined the workflow, reducing the time to results to less than two weeks. The test is covered by Medicare for patients with advanced solid tumors. Guardant Health aims to improve patient outcomes by providing more comprehensive gene coverage. This new test can be ordered either alone or in combination with Guardant360 CDx to support guideline-recommended genomic profiling for advanced breast and lung cancer.

Guardant Health (NASDAQ:GH), a precision oncology company, has been named to the TIME100 Most Influential Companies list. This recognition comes due to the company's impact, innovation, ambition, and success.

Guardant was included in the Innovators section, which features 20 companies from various industries. Key milestones for Guardant include achieving 500 peer-reviewed publications and delivering 500,000 patient tests.

Additionally, the FDA’s Medical Devices Advisory Committee has recommended approval for Shield™, Guardant's blood test for colorectal cancer screening. The FDA's decision is expected later this year.

Guardant Health (Nasdaq: GH) will present data from 16 studies at the 2024 ASCO Annual Meeting, May 31-June 4 in Chicago. The studies highlight the impact of Guardant's blood tests and real-world data on precision oncology and cancer screening. Key presentations include interim data from the RADIOHEAD study showing correlations between epigenomic biomarkers and immunotherapy responses across 13 cancer types.

Presentations will cover the utility of ctDNA for therapy response monitoring, the use of the GuardantINFORM clinical-genomic database to study tumor drivers and resistance, and applications of genomic and epigenomic biomarkers in cancer treatment. Featured studies focus on racial differences in genomic profiles in metastatic breast cancer and the quantification of tumor fractions using the Guardant Infinity platform.