COMPANY:

Guardant Health

P=NA | N=7,000 | GOZILA (UMIN000029315) | "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....The results showed that 24% of participants were able to receive targeted treatment tailored to them based on comprehensive genomic profiling results from the test, which analyzes 74 cancer-related genes. The patients who received targeted treatment guided by liquid biopsy results lived approximately twice as long as those who did not....Patients who received targeted therapy had a median survival of 18.6 months compared to 9.9 months for those who did not."

"Guardant Health, Inc...announced the company and its research collaborators will present data from several studies utilizing Guardant technology to advance precision oncology at the European Society for Medical Oncology Congress (ESMO) in Barcelona, Spain, Sept. 13-17, 2024."

"Guardant Health, Inc...announced a partnership with the Agostino Gemelli University Polyclinic Foundation IRCCS ('Policlinico Gemelli') to establish an in-house liquid biopsy testing service as a part of its diagnostics services within its hospital system. Leveraging Guardant Health’s cutting-edge proprietary digital sequencing platform, this initiative will include on-site analysis of Guardant360 ® CDx liquid biopsy tests directly within the Policlinico Gemelli facilities in Rome, Italy."

"Guardant Health Japan Corp...announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Guardant360® CDx as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC) for consideration of treatment with amivantamab-vmjw combined with chemotherapy. This approval makes the Guardant360 CDx comprehensive genomic profiling panel the first blood-based companion diagnostic to be approved in Japan for the detection of EGFR exon 20 insertion mutations."

P=NA| N=NA | "Guardant Health, Inc...announced Clinical Cancer Research, a journal of the American Association for Cancer Research, will publish results today from the COSMOS study confirming the high sensitivity and specificity of the Guardant Reveal blood test in predicting recurrence of colorectal cancer (CRC)....100% of patients were able to undergo evaluation without the need for tissue testing; 98% specificity in samples from patients without recurrence; 81% longitudinal sensitivity for recurrence in stage II or higher colon cancer; 5.3-month median lead time from ctDNA detection to recurrence."

"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, Inc...announced the launch of a major upgrade to its market-leading Guardant360 liquid biopsy test. The new enhanced test evaluates biomarkers in 739 genes in total, which is 10 times more cancer biomarkers than the previous version of Guardant360 evaluated....The updated Guardant360 test is covered for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service, based on coverage conveyed by Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), under the existing local coverage determination. The test is also covered by all major insurers, representing over 300 million covered lives."

"The US Attorney's Office for the Northern District of California said...that cancer testing company Guardant Health has agreed to settle allegations that it knowingly violated the False Claims Act and regulations of the Defense Health Agency...Under the settlement, Guardant, which specializes in liquid biopsy genomic tests, will pay $913,932.93 to settle the FCA allegations and $31,082.00 in an administrative settlement with DHA."

"Guardant Health filed a lawsuit...against rival cancer genomics firm Tempus AI, alleging that Tempus has infringed a handful of its patents relating to liquid biopsy sequencing methods...Guardant specifically cited Tempus' Tempus xF, Tempus xF+, and Tempus xM Monitor assays as examples, as well as the firm's recently developed minimal residual disease offering, Tempus xM MRD."

"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....The new Guardant360 TissueNext test will be covered for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service, based on coverage conveyed by Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), under the existing local coverage determination."

"Guardant Health...announced its research collaborators from Washington University’s Siteman Cancer Center will lead an oral presentation today at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting...The retrospective study, led by first author Emily Podany...focused on patients with hormone receptor positive (HR+), HER2 negative (HER2-) metastatic breast cancer with PIK3CA mutations, which had an equal incidence in Black and White patients. The 1,327 patients in the study, who were treated at Washington University in St. Louis, Massachusetts General Hospital, and Northwestern University, had the Guardant360 liquid biopsy test as part of clinical care and these results were combined with annotated clinical data. Results indicated that Black patients were significantly less likely than White patients to receive PIK3CA targeted therapy or to be enrolled in a clinical trial for biomarkers that required targetable mutations..."

"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 certification for its Guardant360 CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer....Under the IVDR, Guardant360 CDx is certified as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO (osimertinib), RYBREVANT (amivantamab), or LUMYKRAS (sotorasib), and advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU (elacestrant)."

"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...announced its achievement of surpassing a significant milestone of 500 peer-reviewed publications featuring its technology in esteemed scientific journals. This milestone highlights Guardant Health’s leadership, amassing one of the most robust portfolios of relevant liquid biopsy research studies in the industry."

"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.'"

"Guardant Health, Inc...announced it will present data from nine studies highlighting advances in methylation-based epigenomic analysis for precision oncology at the 2024 American Association for Cancer Research (AACR) Annual Meeting, April 5-10 in San Diego. Multiple poster sessions will report on the utility of using the Guardant Infinity platform across the continuum of cancer care, ranging from predictive histologic subtyping of tumors to cardiac adverse event prediction. Data will also be presented demonstrating strong performance of Guardant Reveal for minimal residual disease (MRD) detection in breast cancer, allowing quantification of ctDNA even in early-stage disease without the need for a tissue specimen."

"The NHS England study – conducted in partnership with The Royal Marsden and Guardant Health – has already enabled over 2000 patients with suspected advanced lung cancer to have a ctDNA blood test before or at the same time that diagnostic biopsies are taken. Analysis of data from Guardant Health’s liquid biopsy testing shows that time to diagnosis for patients with advanced lung cancer in the UK can be slashed by three weeks, allowing faster access to personalised therapies that target the identified mutations."

P=Obs | N=40,000 | ECLIPSE (NCT04136002) | Sponsor: Guardant Health, Inc. | "Guardant Health...announced that results from the ECLIPSE study showing the effectiveness of its Shield blood test for detecting colorectal cancer (CRC) in average-risk adults will be published in the March 14 issue of The New England Journal of Medicine....Highlights of the study results to be published in The New England Journal of Medicine show that Shield demonstrated: 83% sensitivity in detecting individuals with CRC; 88% sensitivity in detecting pathology-confirmed Stages I-III; Sensitivity by stage of: 65% for pathology-confirmed Stage I; 55% for clinical Stage I; 100% for Stage II; 100% for Stage III; 100% for Stage IV. These results are on par with the performance of other guideline-recommended non-invasive screening modalities, where overall sensitivity in detecting colorectal cancer ranges from 74% to 92%."

"Guardant Health, Inc...will present interim data from the COSMOS study supporting the use of Guardant Reveal to predict disease recurrence in patients with early-stage colon cancer at the ASCO 2024 Gastrointestinal Cancers Symposium, January 18-20 in San Francisco....Interim data to be shared at ASCO GI suggest the test is both highly specific (low false positives) and predictive for recurrence, without dependence on a tissue sample....Guardant and its research partners will also present multiple posters at the symposium highlighting the application of Guardant technology in blood-based screening and in identifying potentially targetable mutations in GI cancers, including predictive markers for treatment resistance."

"Guardant Health, Inc...and Hikma Pharmaceuticals PLC...announced an agreement to promote Guardant Health’s portfolio of liquid and tissue biopsy tests for cancer screening, recurrence monitoring and tumor mutation profiling across all solid cancers in countries across the Middle East and North Africa (MENA)...The tests offered include Shield™ for cancer screening and early detection, Guardant Reveal™ for minimal residual disease detection and recurrence monitoring, and Guardant360® and Guardant360 TissueNext™ for comprehensive genomic profiling across all solid cancers."

"Guardant Health, Inc...announced that the U.S. Food and Drug Administration’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for the company’s Shield™ blood test to screen for colorectal cancer on March 28, 2024. The date and details of the meeting are subject to confirmation by the FDA and publication in the Federal Register."

"Cancer Research UK, one of the world’s largest charitable funders of cancer research, its innovation unit, Cancer Research Horizons, and Guardant Health, Inc...today announced a collaboration to explore the sharing of technologies, data, and insights to advance the development and precision of cancer detection and treatment. The agreement will enable the parties to discuss opportunities for collaboration to support the charity’s research and clinical development activities, focusing primarily on its clinical trials run by its Centre for Drug Development."

"Guardant Health, Inc...will present data showing the utility of liquid biopsy tests in the management of breast cancer patients at the San Antonio Breast Cancer Symposium, December 5-9 in San Antonio, Texas. Highlights of the eight poster presentations include the use of blood-based testing to identify actionable biomarkers and predict therapy response in advanced breast cancer, and to detect residual disease and predict recurrence in patients with early-stage breast cancer."

"Guardant Health, Inc...announced it intends to appeal yesterday’s verdict in the U.S. District Court for the District of Delaware related to intellectual property claims brought against Guardant by TwinStrand Biosciences, Inc. and University of Washington...Guardant remains confident that it did not infringe the asserted patents, and the company expects to file additional motions with the U.S. District Court for the District of Delaware and appeal to the U.S. Court of Appeals for the Federal Circuit."

"Guardant Health, Inc...announced that it has launched its blood-based colorectal cancer screening test, Shield, in collaboration with Samsung Medical Center in South Korea. Colorectal cancer (CRC) is one of the most commonly diagnosed cancers and the third-leading cause of cancer-related deaths in South Korea. Guardant Health's Shield test, which can be used for regular CRC screening in eligible individuals, is an innovative test that can detect cancer in its early stages by analysing circulating tumour DNA (ctDNA), which is produced when tumours shed small pieces of their genetic material into the bloodstream. In the pivotal ECLIPSE study, which enrolled over 20,000 patients, the Shield test achieved 83% sensitivity for the detection of colorectal cancer in average-risk adults in the U.S., with specificity of 90%."

"Zydus Lifesciences and Guardant Health have agreed to jointly promote the Guardant360 portfolio of liquid and tissue biopsy tests across India and Nepal...The tests to be promoted include the Guardant360 and Guardant360 TissueNext tests for genomic profiling and the Guardant360 Response test for monitoring response to treatment..."

"Guardant Health, Inc...announced an initiative to integrate Guardant’s comprehensive genomic profiling tests within Flatiron’s OncoEMR®, a leading cloud-based electronic medical record (EMR) tool...Users can easily submit Guardant Health test orders, track real-time status updates, and receive the test results directly in the patient record, via the Molecular Profiling Integration on the OncoEMR platform."

P2 | N=140 | PEGASUS (NCT04259944) | "Guardant Health, Inc...announced that initial results from the PEGASUS trial suggest liquid biopsy may be used in post-surgical clinical management to reduce unnecessary toxicity from chemotherapy and improve the response to standard chemotherapy regimens in patients with stage III or high-risk stage II colon cancer...Initial results show that 34% of patients with a positive liquid biopsy result after surgery had the cancer return, while only 10% of patients with a negative result experienced a relapse. Approximately 40% of patients converted from ctDNA-positive to ctDNA-negative after treatment, suggesting treatment efficacy of chemotherapy for some patients."

"Digital diagnostics company EDX Medical Group announced...that it will distribute two of Guardant Health's cancer liquid biopsy tests in the UK and the Nordic countries...EDX Medical will distribute the Guardant360 CDx advanced cancer genomic test and the Guardant Reveal test for residual disease and recurrence detection in early-stage cancer to the UK private healthcare sector...It will also distribute Guardant360 CDx to the public and private sectors in Sweden, Denmark, Norway, Finland, and Iceland."

"Adicon Holdings Limited...announced that it now offers liquid biopsy tests from Guardant Health...to advance clinical research and the development of new cancer therapies in China. The blood-based tests provide biopharmaceutical companies with access to comprehensive genomic profiling (CGP), also known as tumour mutation profiling, in patients with advanced solid cancers to support investigational drug studies."

"Guardant Health, Inc...announced...that Geisinger Health Plan now offers coverage for the Guardant Reveal™ minimal residual disease (MRD) test. Guardant Reveal is a blood test that detects circulating tumor DNA (ctDNA) in blood after treatment, including surgery, to help oncologists identify cancer patients with residual or recurring disease who may benefit most from adjuvant therapy or surveillance...This policy decision adds to the payor coverage of Guardant Reveal, which received Medicare coverage in August 2022 and additional commercial payor coverage in July 2023."

"Guardant Health...announced the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Guardant360® CDx liquid biopsy test as a companion diagnostic to select patients with unresectable (inoperable) advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy for treatment with ENHERTU® (trastuzumab deruxtecan)....The approval for use of the test as a companion diagnostic with ENHERTU in Japan is an expansion of the approval received from the U.S. Food and Drug Administration (FDA) for the same indication in August 2022."

"Guardant Health, Inc...issued the following statement about the closure of COBRA, a minimum residual disease (MRD) study...We agree with the decision, based on the recent planned interim analysis, to close the COBRA study to new enrollees..."

"Guardant Health, Inc...announced an agreement with Illumina Inc...that resolves their pending litigation and promotes a shared resolution to advance the companies’ long-term, commercial partnership...The companies have also extended their long-standing commercial relationship by agreeing to collaborate on the sharing of specimen samples to advance cancer research, and by entering into a new long-term purchase and supply commitment."

"Guardant Health, Inc...announced...that Blue Cross and Blue Shield of Louisiana now offers coverage for the Guardant Reveal™ molecular residual disease (MRD) test. Guardant Reveal is a blood test that detects circulating tumor DNA (ctDNA) in blood after treatment, including surgery, to help oncologists identify cancer patients with residual or recurring disease who may benefit most from adjuvant therapy or surveillance. It was the first blood-only liquid biopsy test commercially available for MRD testing."

"Guardant Health, Inc...announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360^® CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers. This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022."

"Guardant Health...announced today that Singapore's Health Sciences Authority (HSA) has granted regulatory approval of Guardant360® CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with advanced solid cancers. The Guardant360 CDx test was also approved as a companion diagnostic to identify patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with TAGRISSO® (osimertinib). Guardant360 CDx is the first blood test to be approved by Singapore's HSA for comprehensive genomic profiling for all solid tumors."

"Guardant Health, Inc...announced today that the company and its research collaborators will present data from 17 studies that highlight the contribution of Guardant blood tests and real-world data to advances in precision oncology and cancer screening at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, June 2-6 in Chicago....Guardant Health will present a session highlighting the performance of the Guardant Infinity platform in the detection of homologous recombination deficiency (HRD) status in patients with breast cancer....Guardant Health collaborators will present a session on the ESR1 mutational landscape and the impact of co-existing resistance variants on clinical outcomes in patients with metastatic breast cancer."