This section highlights FDA-related milestones and regulatory updates for drugs developed by Guardant Health (GH).
Over the past two years, Guardant Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RYBREVANT, Guardant360, and Shield™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
RYBREVANT (amivantamab-vmjw) FDA Regulatory Timeline and Events
RYBREVANT (amivantamab-vmjw) is a drug developed by Guardant Health for the following indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 7, 2025
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced The New England Journal of Medicine (NEJM) published results from the Phase 3 MARIPOSA study, which showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement for patients with previously untreated (first-line) locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.1
AI Summary
Johnson & Johnson announced that The New England Journal of Medicine published results from the Phase 3 MARIPOSA study showing that RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) significantly improved overall survival (OS) in patients with untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 19 deletions or L858R mutations. At a median follow-up of 37.8 months, the combination reduced the risk of death by 25 percent compared to the standard TKI osimertinib (hazard ratio 0.75; P=0.005). Median OS for the combination has not been reached and is projected to exceed four years—over one year longer than the three-year median seen with osimertinib.
This chemotherapy-free regimen works by targeting EGFR and MET pathways and engaging the immune system. The safety profile remained consistent over time, with no new long-term risks identified. Researchers say these findings mark a turning point in first-line treatment for EGFR-mutated lung cancer by potentially delaying resistance and extending patient survival.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- March 26, 2025
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson announced positive overall survival (OS) results from the Phase 3 MARIPOSA study. This study compared the combination of RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) versus osimertinib in patients with locally advanced or metastatic non‐small cell lung cancer (NSCLC) carrying EGFR exon 19 deletions or L858R substitutions. The head‐to‐head data showed that the combination significantly extended OS, with the median not yet reached and a projected improvement of over one year beyond the three-year median observed with osimertinib.
The trial positions RYBREVANT plus LAZCLUZE as a promising first-line treatment option for patients with EGFR-mutated NSCLC. These findings mark the first study to demonstrate a statistically significant and clinically meaningful OS benefit over the current standard therapy, offering hope for improved survival and quality of life for lung cancer patients.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 19, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson's announced that on Thursday, the FDA approved Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 14, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced updated results from the Phase 3 MARIPOSA-2 study which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy led to consistent benefit across post-progression outcomes in adult patients with previously treated non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson announced updated results from the Phase 3 MARIPOSA-2 study showing that RYBREVANT® (amivantamab-vmjw) combined with chemotherapy provided consistent benefits in post-progression outcomes for adult patients with previously treated non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions or L858R substitution mutations.
The study reported that at an 18-month follow-up, 50% of patients receiving the combination were still alive compared to 40% treated with chemotherapy alone, indicating a positive trend toward improved overall survival. Additionally, the data showed a significant extension in median time to treatment discontinuation and a reduction in the risk of symptomatic progression, along with a longer time to the next therapy. These improvements suggest that the RYBREVANT® plus chemotherapy regimen may offer a new, promising option for patients with limited treatment alternatives after previous therapies.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 10, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
, Johnson & Johnson announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related reactions (IRRs) with intravenous (IV) Rybrevant (amivantamab-vmjw) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson announced promising results from its open-label Phase 2 SKIPPirr study. This study evaluated an enhanced pre-medication regimen using 8‑mg dexamethasone to reduce infusion-related reactions (IRRs) in patients with advanced non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions or L858R substitution mutations. In the study, patients received dexamethasone twice daily for two days before their first infusion of intravenous Rybrevant, which led to a 22.5% rate of IRRs.
This represents a significant three-fold reduction compared to the 67.4% incidence historically observed with standard IRR management. The findings indicate that this easily accessible prophylactic strategy can improve the treatment experience by lowering the occurrence of IRRs, ensuring patients can continue therapy with fewer interruptions.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- September 8, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced longer follow-up data from the landmark Phase 3 MARIPOSA study which showed first-line treatment with RYBREVANT® (amivantamab-vmjw) combined with LAZCLUZE™ (lazertinib) provided consistent benefit across long-term outcomes compared to osimertinib monotherapy in adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
AI Summary
Johnson & Johnson recently shared longer follow-up results from the Phase 3 MARIPOSA study, which evaluated a chemotherapy-free treatment for advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations. The study showed that first-line treatment with the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) provided consistent long-term benefits compared to osimertinib monotherapy. At nearly three years of follow-up, patients on the RYBREVANT® plus LAZCLUZE™ regimen demonstrated an improved overall survival trend. By targeting both the EGFR and MET pathways, this combination therapy offers the potential for prolonged disease control and improved survival outcomes in patients with this specific type of NSCLC. Future ongoing assessments will continue to monitor these long-term outcomes and further support the benefit of the combination therapy.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- August 20, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced that that the U.S. Food and Drug Administration (FDA) approved RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.1,2
AI Summary
Johnson & Johnson announced that the U.S. FDA approved the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) for first-line treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) carrying EGFR exon 19 deletions or exon 21 L858R substitution mutations, as determined by an FDA-approved test. This approval is based on positive results from the Phase 3 MARIPOSA study, which found that the combination reduced the risk of disease progression or death by 30 percent compared to osimertinib, with a nine-month longer median duration of response. The regimen is notable as the first and only chemotherapy-free, multitargeted treatment approved for patients with these EGFR mutations, offering a promising alternative to traditional chemotherapy and aiming to improve patient outcomes and quality of life.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- July 3, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced that that Health Canada, through a Priority Review, has issued a Notice of Compliance (NOC) for RYBREVANT® (amivantamab) in combination with platinum-based chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.1
AI Summary
Johnson & Johnson announced that Health Canada has granted a Notice of Compliance for RYBREVANT® (amivantamab) when used in combination with platinum-based chemotherapy (carboplatin and pemetrexed) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that features EGFR Exon 20 insertion mutations. This regulatory milestone, achieved through a Priority Review, marks a significant advancement in addressing an aggressive form of lung cancer that currently has limited treatment options and a poorer prognosis. The recent approval is supported by data from the Phase 3 PAPILLON study, which showed that the combination therapy reduced the risk of disease progression or death by 60% compared to chemotherapy alone. Health Canada’s decision underscores the potential of targeted therapies like RYBREVANT® to provide improved outcomes and renewed hope for patients with this rare mutation.
Read Announcement- Drug:
- RYBREVANT (amivantamab-vmjw)
- Announced Date:
- June 17, 2024
- Indication:
- Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Announcement
Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) RYBREVANT® (amivantamab-vmjw) in certain patients with non-small cell lung cancer (NSCLC).
AI Summary
Johnson & Johnson has submitted a Biologics License Application (BLA) to the U.S. FDA for a new fixed combination treatment, which pairs amivantamab with recombinant human hyaluronidase for subcutaneous administration (SC amivantamab). This submission covers all currently approved or pending indications of intravenous RYBREVANT® (amivantamab-vmjw) in select non-small cell lung cancer (NSCLC) patients with EGFR mutations. Data from the Phase 3 PALOMA-3 study showed that SC amivantamab provided a comparable overall response to its IV counterpart while significantly reducing infusion-related reactions by five-fold and shortening the administration time to about five minutes. Additionally, the study observed improvements in overall survival, progression-free survival, and duration of response. This advancement offers a more convenient option for patients and may enhance treatment experiences with NSCLC therapy.
Read Announcement
Guardant360 FDA Regulatory Timeline and Events
Guardant360 is a drug developed by Guardant Health for the following indication: Advanced solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Guardant360
- Announced Date:
- June 2, 2025
- Indication:
- Advanced solid tumors.
Announcement
Guardant Health, Inc announced that the results of the Phase III SERENA-6 trial - sponsored by AstraZeneca - demonstrate the clinical value of the Guardant360® CDx test in a circulating tumor DNA-guided approach to detect and treat emerging resistance in 1st-line therapy ahead of radiological disease progression in breast cancer.
AI Summary
Guardant Health announced positive results from the Phase III SERENA-6 trial, sponsored by AstraZeneca. The trial showed that using the Guardant360® CDx test in a circulating tumor DNA (ctDNA)-guided approach can detect emerging endocrine resistance in advanced breast cancer patients before it appears on radiological scans. Specifically, the test identified the emergence of ESR1 mutations in patients with hormone receptor-positive, HER2-negative breast cancer. After detecting the mutation, patients switched from their current aromatase inhibitor therapy to AstraZeneca’s camizestrant, while continuing treatment with a cyclin-dependent kinase 4/6 inhibitor. This early switch in treatment led to a 56% reduction in the risk of disease progression or death, highlighting the clinical value of using ctDNA monitoring with the Guardant360® CDx test. The study’s findings suggest that this liquid biopsy approach can change clinical practice and improve patient outcomes.
Read Announcement- Drug:
- Guardant360
- Announced Date:
- April 28, 2025
- Indication:
- Advanced solid tumors.
Announcement
Guardant Health, Inc. announced the launch of Guardant360® Tissue, the first molecular profiling test for tumor tissue that incorporates comprehensive multiomics analysis—including DNA, RNA, AI-powered PD-L1 and exome-wide methylation data—to provide researchers and cancer care teams with a more comprehensive view of cancer.
AI Summary
Guardant Health, Inc. has launched Guardant360® Tissue, a breakthrough test that is the first of its kind to provide comprehensive molecular profiling of tumor tissue. This innovative test uses multiomics analysis to examine DNA, RNA, AI-powered PD-L1, and exome-wide methylation data, giving cancer care teams and researchers a deeper, more accurate view of a tumor’s unique biology. By integrating both genomic and epigenomic insights, Guardant360® Tissue aims to support the use of various therapeutic strategies, including PARP inhibitors and immunotherapies.
Using the Guardant Infinity™ smart liquid biopsy platform, the test minimizes the amount of tissue required by needing 40% fewer slides than traditional methods. This improvement enables a greater number of patients to be tested while preserving precious tissue, marking a significant advance in precision oncology and cancer research.
Read Announcement- Drug:
- Guardant360
- Announced Date:
- September 18, 2024
- Indication:
- Advanced solid tumors.
Announcement
Guardant Health, Inc announced the peer-reviewed journal Nature Medicine published results from the SCRUM-Japan GOZILA study confirming that selecting targeted therapy on the basis of Guardant360® CDx liquid biopsy results may significantly extend survival for patients with advanced cancer.
AI Summary
Guardant Health announced that a study published in Nature Medicine supports the significant benefits of using its Guardant360® CDx liquid biopsy to guide targeted therapy for advanced cancer patients. The SCRUM-Japan GOZILA study involved over 4,000 patients, and results showed that 24% of these patients received personalized treatment based on genomic profiling from a simple blood test. Patients who received targeted therapy nearly doubled their median survival compared to those who did not. This study is the first large-scale investigation to show that liquid biopsy-based treatment selection can extend survival, marking an important step forward in cancer care. The less invasive nature of liquid biopsies, along with the ability to perform repeated tests, could change how doctors choose treatments for advanced cancer, potentially leading to better outcomes for many patients.
Read Announcement- Drug:
- Guardant360
- Announced Date:
- July 23, 2024
- Indication:
- Advanced solid tumors.
Announcement
Guardant Health, Inc. announced the launch of a major upgrade to its market-leading Guardant360 liquid biopsy test.
AI Summary
Guardant Health, Inc. recently launched a major upgrade to its market-leading Guardant360 liquid biopsy test. The enhanced test now runs on the Guardant Infinity smart liquid biopsy platform and evaluates biomarkers in 739 genes—about 10 times more genes than the previous version. This expanded coverage includes all guideline-recommended genomic biomarkers for advanced solid tumors and many emerging biomarkers. It also offers tumor burden quantification with 10 times higher sensitivity, providing oncologists with a much clearer picture of each patient’s cancer profile to better guide targeted treatment decisions.
The upgraded test is covered by Medicare and major private payers, ensuring wide accessibility for patients with advanced solid tumor cancers. This development represents an important step in providing more precise and comprehensive tumor profiling to improve treatment outcomes for patients with advanced cancer.
Read Announcement- Drug:
- Guardant360
- Announced Date:
- June 4, 2024
- Indication:
- Advanced solid tumors.
Announcement
Guardant Health, Inc. announced the launch of a new version of its Guardant360 TissueNext test that expands the number of genes it identifies in a tumor tissue sample to 498.
AI Summary
Guardant Health, Inc. has launched a new version of its Guardant360 TissueNext test that now covers 498 genes in tumor tissue samples. This upgrade expands the number of cancer biomarkers detected, including genes that are recommended by clinical guidelines, helping oncologists better decide which treatments may work best for patients with advanced solid tumors.
The improved test features operational enhancements that streamline the process and reduce the time it takes to get results, aiming to deliver answers in less than two weeks. Additionally, the new test is covered by Medicare fee-for-service for patients with advanced solid tumor cancers, under the Molecular Diagnostics Services program. This broader gene coverage is a step forward in precision oncology, giving doctors more detailed information to tailor treatment strategies and strive for better outcomes in the fight against cancer.
Read Announcement- Drug:
- Guardant360
- Announced Date:
- May 21, 2024
- Indication:
- Advanced solid tumors.
Announcement
Guardant Health, Inc announced certification for its Guardant360® CDx blood test under the European Union's In Vitro Diagnostic Regulation (IVDR 2017/746).
AI Summary
Guardant Health, Inc has reached a key milestone by earning IVDR certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). This certification, granted by TÜV SÜD, confirms that the test meets strict European standards for molecular diagnostics. Guardant360 CDx uses next-generation sequencing technology to detect genomic alterations in solid tumors by analyzing circulating tumor DNA from a simple blood draw. The test serves as a companion diagnostic to help identify patients with advanced non-small cell lung cancer and breast cancer who may benefit from targeted therapies. By meeting the rigorous IVDR requirements, the test is expected to encourage broader use of comprehensive genomic profiling, allowing more oncologists to make informed decisions and offer personalized treatment options to cancer patients in the EU.
Read Announcement
Shield™ blood test FDA Regulatory Timeline and Events
Shield™ blood test is a drug developed by Guardant Health for the following indication: for colorectal cancer (CRC) screening.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Shield™ blood test
- Announced Date:
- April 29, 2025
- Indication:
- for colorectal cancer (CRC) screening
Announcement
Guardant Health, Inc presented data today from a study showing that its methylation-based Shield™ multi-cancer detection (MCD) test demonstrated high specificity and clinically meaningful sensitivity across ten tumor types,* while also providing information to guide clinical diagnostic evaluation.
AI Summary
Guardant Health, Inc. shared new study data showing promising results for its methylation-based Shield™ multi-cancer detection (MCD) test. The test achieved a high specificity of 98.5% and demonstrated clinically meaningful sensitivity by detecting multiple cancer types across ten tumor types. Notably, the test reached an overall sensitivity of 60% and 74% sensitivity in the six most aggressive cancers. It also provided 89% accuracy in predicting the cancer signal of origin, information that can help guide further clinical diagnostic evaluation.
These findings, presented at the AACR annual meeting, underscore the potential of the Shield MCD test for early detection of cancer through a simple blood draw. The study’s results support the test’s role as an innovative screening option, aiding healthcare professionals in identifying cancer in asymptomatic individuals when treatment may be more effective.
Read Announcement- Drug:
- Shield™ blood test
- Announced Date:
- March 11, 2025
- Indication:
- for colorectal cancer (CRC) screening
Announcement
Guardant Health, Inc. announced the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Shield™ blood test for colorectal cancer (CRC) screening.
AI Summary
Guardant Health recently announced that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for its Shield™ blood test. This designation is given to innovative tests that provide new clinical insights not available through other methods. Shield is used for colorectal cancer (CRC) screening and offers a non-invasive option for patients at average risk aged 45 and older.
The ADLT status confirms the test’s value in improving patient screening and care. Medicare will reimburse the Shield test at $1,495 during a nine‐month period starting April 1, 2025. After this initial period, Guardant Health will collect private-payer payment data to help set the Medicare pricing from January 1, 2026, through December 31, 2027. This move is expected to drive wider access to the test and enhance early detection of colorectal cancer.
Read Announcement- Drug:
- Shield™ blood test
- Announced Date:
- July 29, 2024
- Indication:
- for colorectal cancer (CRC) screening
Announcement
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.
AI Summary
Guardant Health’s Shield blood test has received FDA approval as the first blood test to be used as a primary screening option for colorectal cancer in adults aged 45 and older who are at average risk. This approval means that physicians can offer Shield in much the same way as other non-invasive screening methods recommended in guidelines. Notably, Shield also meets the performance requirements for Medicare coverage, making it a viable option for a wide range of patients. The test offers an easy, convenient, and less invasive alternative to colonoscopies or stool tests, potentially improving screening rates and early detection of colorectal cancer, which is critical for effective treatment. With this FDA decision, Guardant Health is set to launch Shield soon, empowering healthcare providers to expand early cancer detection opportunities using a simple blood draw during routine office visits.
Read Announcement- Drug:
- Shield™ blood test
- Announced Date:
- May 23, 2024
- Indication:
- for colorectal cancer (CRC) screening
Announcement
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.
AI Summary
Guardant Health, Inc. announced that the FDA’s Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel has strongly recommended approval of its Shield™ blood test. The test is designed for colorectal cancer (CRC) screening in average-risk adults aged 45 and older. The panel voted favorably on key aspects of the test, finding that it is safe, effective, and that its benefits outweigh any potential risks. This strong recommendation highlights Shield’s potential as a convenient and non-invasive alternative to current stool-based screening options, which often face challenges in patient adherence.
This positive review from the advisory committee, based on data from the pivotal ECLIPSE study, paves the way for Shield to become the first FDA-approved blood test for CRC screening that could meet Medicare coverage requirements. The FDA is expected to make a final decision on approval later this year.
Read Announcement- Drug:
- Shield™ blood test
- Announced Date:
- May 16, 2024
- Indication:
- for colorectal cancer (CRC) screening
Announcement
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.
AI Summary
Guardant Health, Inc. will share promising new data at the 2024 Digestive Disease Week (DDW) conference in Washington, DC. The company is set to present findings from two real-world studies that demonstrate the clinical value of its Shield™ test. These studies specifically focus on colorectal cancer (CRC) screening, potentially offering healthcare providers a reliable tool for early detection and treatment of this common disease.
The data highlights the potential of the Shield™ test to improve screening processes and patient outcomes by providing accurate, efficient results in a real-world setting. This development is particularly important as the burden of colorectal cancer continues to impact many lives. Guardant Health’s participation in DDW underscores its commitment to advancing cancer screening technology and providing clinicians with innovative solutions for cancer detection.
Read Announcement- Drug:
- Shield™ blood test
- Announced Date:
- April 22, 2024
- Estimated Event Date Range:
- May 23, 2024 - May 23, 2024
- Target Action Date:
- May 23, 2024
- Indication:
- for colorectal cancer (CRC) screening
Announcement
Guardant Health, Inc 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.
AI Summary
Guardant Health, Inc. announced that the U.S. Food and Drug Administration’s Medical Devices Advisory Committee, specifically the Molecular and Clinical Genetics Panel, will review its premarket approval (PMA) application for the Shield™ blood test on May 23, 2024. The Shield test is designed for colorectal cancer screening and aims to provide an easier and more accurate method for detecting colorectal cancer early, when treatment is most effective. Guardant Health highlighted that the review will focus on clinical data from its ECLIPSE study, which supports the potential of the Shield test to overcome barriers seen in current screening methods. The company looks forward to discussing this innovative approach with the panel of experts, hoping that it will offer a more convenient screening option and improve early detection and overall patient outcomes.
Read Announcement
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