COMPANY:

Guardant Health

"Guardant Health, Inc...has announced support for an investigator initiated study led and conducted by The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) to evaluate patient compliance with a blood-based test for colorectal cancer (CRC) screening. In this study, The Ohio State University Guardant Shield Colorectal Cancer Screening Project, individuals from minority and underserved populations aged 45 and older who are in need of CRC screening will have the option to receive the Shield blood test, administered by a mobile phlebotomist, as part of their engagement with a community health van."

"Lunit said it has completed validation of Lunit Scope PD-L1, its artificial intelligence pathology analysis solution, in Clinical Laboratory Improvement Amendments (CLIA)'s laboratory-developed test (LDT)...The company conducted the test at Guardant Health's CLIA Lab."

"Guardant Health, Inc...announced that it has submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval (PMA) application for Shield™, Guardant Health’s blood test to screen for colorectal cancer (CRC). The submission is comprised of data from the company’s positive ECLIPSE study, an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults."

"Sermonix Pharmaceuticals is starting a Phase III trial of endocrine therapy lasofoxifene for patients with locally advanced or metastatic ER+/HER2-breast cancer with an estrogen receptor 1 (ESR1) mutation, the company said on Thursday. Sermonix has partnered with Guardant Health for the trial and will use the Guardant360 CDx liquid biopsy assay, a blood-based sequencing test that detects mutations from circulating tumor DNA, to determine eligibility by screening patients for ESR1 variants. The trial, dubbed the ELAINE-3 study, will compare lasofoxifene against fulvestrant, an estrogen receptor antagonist, both in combination with Eli Lilly's CDK4/6 inhibitor Verzenio (abemaciclib)....Sermonix expects to dose the first patient for the trial in the first half of this year and plans to enroll 400 patients in total."

"Guardant Health, Inc...announced the initiation of a new study to examine patient preference for Shield, Guardant Health’s blood test to screen for colorectal cancer (CRC), and if having the option of a blood test improves patient adherence to screening. The study will be conducted by the Center for Asian Health Equity – University of Chicago Medicine (CAHE-UCM)."

"Guardant Health, Inc...announced...UnitedHealthcare (UHC) now covers the Guardant360® CDx liquid biopsy test for patients enrolled in its commercial policies for all FDA-approved companion diagnostic indications...The new policy coverage by UnitedHealthcare is in addition to existing coverage of the Guardant360 CDx test under UHC Medicare Advantage policies for comprehensive genomic profiling of all solid tumors."

"Guardant Health Inc...announced today a strategic collaboration on the development, regulatory approval and commercialization of the Guardant360^® CDx and Guardant360 TissueNext™ assays as companion diagnostics for taletrectinib in the United States and European Union....The collaboration will focus on the use of the Guardant tests for comprehensive genomic profiling to identify patients with the specific tumor mutations that are targeted by taletrectinib."

"Guardant Health, Inc...announced today the introduction of Guardant Galaxy^TM, a suite of advanced analytical technologies developed internally and through outside partnerships to enhance the performance and clinical utility of Guardant Health’s portfolio of cancer tests and to power the next generation of biomarker and drug discovery....The AI-powered scoring algorithm for the enhanced Guardant360 TissueNext PD-L1 test, which is now commercially available, improved detection of the cancer biomarker by more than 20 percent compared to manual pathologist interpretation in the most challenging non-small cell lung cancer (NSCLC) cases....Guardant Health also plans to expand the Guardant Galaxy technology suite over time to include other technology partnerships that will support additional segments of its cancer diagnostics portfolio."

"On January 27, 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with elacestrant."

"Guardant Health, Inc...is partnering with The Royal Marsden NHS Foundation Trust on Part C of its 'Tracking mutations in cell free DNA to predict Relapse in eArly Colorectal Cancer' (TRACC) study, which will evaluate the use of circulating tumor DNA (ctDNA) to guide chemotherapy treatment decisions after curative-intent surgery in patients with early-stage colorectal cancer (CRC)...The trial is intended to determine whether patients can be spared unnecessary chemotherapy and the associated side effects if they test negative for ctDNA using the Guardant Reveal™ blood test following surgery."

"Guardant Health, Inc...announced...that new data from its portfolio of blood tests will be presented at the ASCO 2023 Gastrointestinal Cancers Symposium, January 19-21 in San Francisco...The 10 poster presentations highlight the use of the Guardant360® and Guardant Reveal blood tests and the GuardantINFORM real-world evidence dataset to identify critical biomarkers and acquired co-mutations, track associated treatment patterns and clinical outcomes, and predict disease recurrence from minimal residual disease (MRD) detection."

"Guardant Health, Inc...and Susan G. Komen®...announced...that they have entered into a partnership to bring the patient perspective to the development of clinical studies that help identify early-stage breast cancer patients who are at high risk of disease recurrence and may benefit from additional monitoring or therapy...The focus of the partnership will be to support the development of clinical utility data for Guardant Reveal™, a blood test for the detection of minimal residual disease (MRD) in patients with early-stage breast cancer."

"Guardant Health, Inc...announced...positive results from ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode), an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer (CRC) in average-risk adults...In this study, two configurations of a multimodal blood-based screening test were evaluated independently - a cell-free DNA (cfDNA)-only test and a cfDNA test with protein biomarkers. The announced results were derived from the cfDNA-only test, which outperformed the cfDNA test with protein biomarkers."

"Guardant Health, Inc...announced...it has entered into a collaboration with AstraZeneca to pursue the development, regulatory approval and commercialization of the Guardant360® CDx blood test as a companion diagnostic to identify patients with ESR1-mutated metastatic breast cancer. The initiative is part of a larger strategic collaboration investigating the use of liquid biopsy as a tool to inform early therapy intervention."

"Guardant Health, Inc...announced...that new data from its portfolio of blood tests will be presented at the 2022 San Antonio Breast Cancer Symposium, December 6-10 in San Antonio, Texas. The six poster presentations highlight the use of the Guardant360® blood test and the GuardantINFORM™ real-world evidence dataset to identify critical biomarkers and acquired co-mutations, track associated treatment patterns and clinical outcomes, and monitor molecular response to therapy based on specific breast cancer driver mutations."

"Codex Genetics...has signed on as the exclusive distributor of Guardant Health's precision oncology tests in Hong Kong and Macau...According to Hong Kong-based Codex, the deal includes the liquid biopsy tests Guardant360 for solid tumor mutation profiling, Guardant Reveal for residual disease and recurrence monitoring in early-stage colorectal cancer patients, and Guardant360 Response for predicting patient responses to immunotherapy and targeted therapy, as well as the tissue-based Guardant TissueNext genomic profiling panel."

"Guardant Health, Inc...announced...the introduction of GuardantINFINITY™, a next-generation liquid biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development."

"Guardant Health, Inc...announced today that new data from its portfolio of blood tests will be presented at the 2022 European Society for Medical Oncology (ESMO) Congress, September 9-13 in Paris, France. Among the seven abstracts are an oral presentation and posters highlighting the use of Guardant Health’s blood tests and real-world evidence dataset to advance cancer therapy trials, predict and monitor patient response to therapy, and identify genomic mechanisms of acquired resistance to cancer therapy."

"Guardant Health, Inc...announced an expanded collaboration with Merck KGaA...to further leverage the GuardantINFORM real-world evidence (RWE) platform to help accelerate development efforts for Merck KGaA, Darmstadt, Germany‘s precision oncology pipeline. The expanded strategic collaboration will focus on therapy development for core cancer indications with significant unmet need....Under the expanded collaboration, Merck KGaA, Darmstadt, Germany, will work closely with data scientists at Guardant Health on a variety of therapy development initiatives that utilize the genomics and clinical information accessible through the GuardantINFORM platform."

"Guardant Health Inc...announced...that Guardant Reveal™, the only tissue-free test for the detection of residual and recurrent disease for colorectal cancer (CRC), is now available for patients with breast and lung cancers...The Guardant Reveal blood test improves the management of early-stage cancer patients by detecting circulating tumor DNA (ctDNA) in blood after surgery—without the need for a tissue biopsy—to identify patients with minimal residual disease (MRD) who have a higher risk for recurrence and may benefit from additional therapy."

"'This real-world study improves our understanding of how resistance mutations to osimertinib emerge over time, with new insights on when EGFR C797X mutations overtake MET amplifications as the most commonly acquired resistance mechanism,' said Suresh Ramalingam...'The analysis characterizes the increased frequency of EGFR C797X mutations as patients are treated with first-line osimertinib for longer durations, reinforcing the need for next-generation EGFR inhibitors to address C797X-driven resistance.'"

"Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC)...FDA also approved the Life Technologies Corporation’s Oncomine™ Dx Target Test (tissue) and the Guardant Health, Inc.’s Guardant360® CDx (plasma) as companion diagnostics for Enhertu."

"Guardant Health Inc...and Blueprint Medicines Corporation...announced today they are presenting new data demonstrating that the EGFR C797X mutation is the most common resistance mechanism to osimertinib therapy for patients with advanced non-small cell lung cancer (NSCLC). The results are being reported today at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer in Vienna...The analysis evaluated genomics data from the Guardant360 circulating tumor DNA (ctDNA) test for more than 2,000 patients who had any EGFR mutation and treatment with osimertinib, a third-generation EGFR TKI (tyrosine kinase inhibitor) and the current standard of care for patients with advanced-stage NSCLC with common EGFR mutations."

"Guardant Health, Inc...announced today that studies utilizing its portfolio of blood tests and real-world data will be presented at the IASLC 2022 World Conference on Lung Cancer (WCLC 2022), hosted by the International Association for the Study of Lung Cancer, August 6-9 in Vienna, Austria. Among the 10 abstracts are oral presentations and posters highlighting the use of Guardant360™ to help physicians inform treatment decisions, GuardantOMNI™ to advance cancer therapy trials, and GuardantINFORM™ for targeted drug development to improve outcomes for patients with lung cancer....'The data from retrospective and real-world analyses will show how blood-based tests provide critical insights into tumor evolution and treatment resistance throughout each lung cancer patient’s treatment journey and contribute more broadly to further developing the field of thoracic oncology'."

"Guardant Health, Inc...announced today that Palmetto GBA...has conveyed 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 surgery to help oncologists identify cancer patients with residual or recurring disease who may benefit most from adjuvant therapy. It is the first blood-only liquid biopsy test available for MRD testing in patients with colorectal cancer (CRC)."

"Guardant Health, Inc...and Adicon Holdings Limited...announced a strategic partnership to offer Guardant Health's comprehensive genomic profiling (CGP) tests to biopharmaceutical companies conducting clinical trials in China...As part of the relationship, Guardant Health will license to Adicon its industry-leading liquid biopsy technology, including the Guardant360® and GuardantOMNITM tests, and the Guardant360 TissueNextTM tissue-based biopsy for patients with any solid cancerous tumor."

"Guardant Health, Inc...and the Vall d’Hebron Institute of Oncology (VHIO)...announced that the first blood-based cancer testing services in Europe based on Guardant Health’s industry-leading digital sequencing platform are now available at the VHIO liquid biopsy testing facility in Barcelona...This testing service will provide essential genomic information through comprehensive genomic profiling (CGP) for patients with any solid cancerous tumor."

"Guardant Health, Inc...announced today it will present new data at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 in Chicago. Among the 19 abstracts are oral presentations highlighting the use of real-world data to identify resistance to early treatment in advanced breast cancer and the use of enhanced biomarker analysis to evaluate progression-free survival data in metastatic breast cancer therapy."

"Guardant Health, Inc...announced data showing its blood-based multimodal test achieved clinically significant thresholds of sensitivity and specificity in detecting colorectal cancer (CRC). These data were presented during an oral presentation at Digestive Disease Week 2022..The assay used in this analysis integrates genomics and epigenomics for CRC detection. An updated version of this assay that incorporates the use of proteomics, Shield™, is now available as a laboratory developed test for eligible individuals by prescription only through healthcare professionals."

"Guardant Health, Inc...announced the availability of Shield™, the company’s first blood-based test for the detection of early-stage colorectal cancer (CRC). The test, which only requires patients to complete a simple blood draw, is intended for adults age 45 and older who are not up to date with recommended screening guidelines, show no symptoms, and are at average risk for CRC."

"Guardant Health, Inc...announced new data demonstrating the ability of the company’s investigational next-generation Guardant SHIELD™ multi-cancer assay to accurately detect early-stage cancers...Data from the presentation show that the next-generation Guardant SHIELD multi-cancer screening assay achieved sensitivity (detection rates) of 90% (n=692) in stages I and II colorectal cancer (CRC) and 87% (n=55) in stages I and II lung cancer. For more advanced cancer (stages III and IV), sensitivity was 93% (n=582) for CRC and 93% (n=136) for lung cancer."

"Guardant Health, Inc...announced a partnership with Epic...to integrate the company’s broad portfolio of cancer tests with Epic. This integration will make it easier for health systems, community healthcare providers and retail health clinics to make Guardant Health blood tests part of routine clinical care by providing direct ordering access and results delivery...In addition to Guardant SHIELD, clinicians will be able to order current flagship tests such as Guardant360® CDx and Guardant360 Response™ to help physicians inform treatment decisions for patients with advanced cancer, and Guardant Reveal™ to detect residual and recurrent disease in patients with early-stage cancer."

"Guardant Health, Inc...provided the following statement regarding a lawsuit filed by Illumina that seeks to challenge Guardant Health’s ownership and authorship of a portion of its intellectual property and to suppress competition in the market...'Illumina is using the courts to retaliate against us for registering concerns about the antitrust implications of Illumina’s acquisition of Grail – another provider of blood-based cancer tests – and in an attempt to slow us down in the marketplace as we get ready to launch our blood test to screen for early signs of colorectal cancer'."

"The Ministry of Health, Labour and Welfare (MHLW) 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 granted approval as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda® (pembrolizumab) and patients with MSI-High advanced colorectal cancer (CRC) who may benefit from Opdivo® (nivolumab)."

"Guardant Health, Inc...announced...it will present new data from its broad portfolio of blood tests at the American Association for Cancer Research (AACR) Annual Meeting from April 8-13, 2022. Included in the presentation will be data from its multi-cancer screening assay, next-generation Guardant SHIELD."

"Guardant Health, Inc...announced that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for Guardant360 TissueNext™ under the existing local coverage determination (LCD) (MolDX: Next-Generation Sequencing for Solid Tumors). Guardant360 TissueNext is the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment...The policy covers Guardant360 TissueNext for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service."

"A new judicial order this week has denied, in part, Guardant Health's motion to dismiss Natera's counterclaims to its initial false advertising suit, the first volley in what has since become a bidirectional legal battle, with each company making claims that the other has misled customers and the public about their liquid biopsy minimal residual disease assays, Guardant Reveal and Signatera."

"Guardant Health, Inc....announced it will present data highlighting the clinical utility of its liquid biopsy tests in the treatment and management of early- to late-stage gastrointestinal cancers, including colorectal cancer, at the 2022 ASCO Gastrointestinal Cancers Symposium being held January 20-22, 2022."

"Guardant Health, Inc...announced today the enrollment of the first patient in the SHIELD (Screening for HIgh-frEquency maLignant Disease) LUNG study, a nearly 10,000-patient prospective, registrational study to evaluate the performance of its next-generation Guardant SHIELD blood test in detecting lung cancer in high-risk individuals ages 50-80. The study is anticipated to run in approximately 100 centers in the United States and Europe."

"Guardant Health, Inc...announced that it has reached an agreement to settle all pending litigation concerning the company’s digital sequencing technology patents with Foundation Medicine, Inc. Pursuant to the settlement agreement, Foundation Medicine will pay Guardant Health $25 million as well as future royalties for the remaining term of the licensed digital sequencing technology patents. In turn, Guardant Health will grant Foundation Medicine a non-exclusive license to a defined subset of its digital sequencing technology patents. As a result of this settlement, all pending patent litigation between Foundation Medicine and Guardant Health will be dismissed."

"Guardant Health, Inc...announced...that it has reached its target enrollment of 12,750 patients in ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter), a registrational study to evaluate the performance of its LUNAR™-2 blood test to detect colorectal cancer (CRC) in average-risk adults. Subject to positive study results, the number of patients currently enrolled in ECLIPSE is targeted to support a premarket approval (PMA) submission to the U.S. Food and Drug Administration in 2022."

P=NA, N=NA; "Another study (Abstract P1-18-07) using the GuardantINFORM platform demonstrated that, for advanced breast cancer patients with PIK3CA mutations identified using the Guardant360 liquid biopsy and subsequently treated with alpelisib, there was no significant difference in treatment outcomes regardless of whether they had clonal or subclonal PIK3CA mutations. This suggests patients with these mutations may benefit from alpelisib targeted therapy irrespective of mutation clonality."