TEST:

GuardantREVEAL

"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."

Patients with ctDNA positivity experienced recurrence at a higher rate than the ctDNA- patients, indicating the potential role of ctDNA in predicting recurrence after curative-intent transplant. Based on sequential testing, LT has the potential to clear ctDNA, demonstrating the capability of LT in the treatment of systemic disease. Transplant providers should be aware of the potential of donor-derived cell-free DNA and improved approaches are necessary to address such concerns.

The detection of ctDNA may be a useful biomarker for the management of early-stage cancer patients to identify patients who are at high risk of recurrence. Patients with stage II or III TNBC undergoing neoadjuvant docetaxel and carboplatin chemotherapy on a clinical trial (NCT02124902) followed by surgery were included in this study. ctDNA is detected with a tissue-free MRD assay with high sensitivity and specificity for distant recurrence in early-stage TNBC. Furthermore, the presence of ctDNA during follow-up is a prognostic indicator. Additional prospective studies are needed to assess the clinical utility of ctDNA monitoring in early-stage TNBC.

Detection of ctDNA after adjuvant chemotherapy was highly prognostic in an EBC cohort. ctDNA testing warrants further investigation as a tool to identify EBC patients at high risk for recurrence during follow-up who may benefit from early interventions. Disclosure Statement: The authors declare the following: D.D. and M.C. are employees of Guardant Health.

"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."

We show a plasma-only genomic- and methylation-based assay to have sensitive and specific detection of MRD in stage II-III colon cancer. Serial measurement provides superior performance versus one-time measurement at Day 28 post-surgery and detects targetable variants prior to recurrence. >

"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."

Detection of ctDNA after adjuvant chemotherapy was highly prognostic and demonstrated high specificity in an early-stage breast cancer cohort. Larger, prospective studies are needed to confirm the prognostic value of ctDNA in the post-treatment setting and assess the clinical utility of MRD detection in this population.

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."

Results from prospective randomized studies will further define the clinical role of MRD detection in resectable CRC. Evidence for tissue-agnostic MRD assays is building across tumor types with continuous improvements in sensitivity and specificity.

"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."

"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."

P3; The study is conducted in accordance with the precepts established in the Declaration of Helsinki and Ethical Guidelines for Medical and Biological Research Involving Human Subjects. Written informed consent will be obtained from all eligible patients prior to registration.

Patients with poor genomic profile and positive MRD derived significant benefit from ACT (median RFS, 8.0 m vs. 2.0 m; HR, 0.25 [95% CI, 0.07–0.82]), while no significant benefit was observed in other groups. Conclusions Pretreatment genomic profile and postoperative MRD by ctDNA analysis accurately stratify the prognosis and may guide personalized ACT in pts with resectable CRM.

Conclusions This longitudinal evaluation of a plasma-only methylation based ctDNA assay demonstrates ctDNA detection and dynamic changes in a large EBC cohort. Potential prognostic and predictive applications warrant further evaluation.

Of the 23 LB+ pts receiving FOLFIRI after CAPOX, 12 remained LB+ (52%) among which 6 relapsed, while 11 were converted to LB- remaining relapse-free at the time of analysis (48%), thus suggesting an effect of FOLFIRI in the MRD setting. Conclusions LB may be used to guide the post-surgical clinical management of CC pts by reducing unnecessary toxicity and by improving the response to standard chemotherapy. Ongoing and newly designed randomized trials trials will define the clinical utility of LB for MRD in colon cancer.

"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."

P=N/A; Not yet recruiting --> Recruiting

P=N/A; Initiation date: Mar 2023 --> Jun 2023

Support: U10CA180868, -180822; UG1CA189867; GuardantHealth. Clinical trial information: NCT04068103.

P=N/A; The trial will determine whether ctDNA guided ACT is non-inferior to SOC ACT in patients with fully resected high risk stage II and stage III resected CRC, with the potential to significantly reduce unnecessary ACT and the toxicity associated with it.

We present a plasma-only method that has high PPA and PPV with WBC genotyping for classifying non-tumor, CH variants in the cfDNA. Further investigation is underway to improve the sensitivity of annotating rare CH variants. Accurate CH identification is critical for treatment selection across targeted therapies, particularly for loss of function variants in DNA repair genes that may confer sensitivity to PARPi or ATRi therapies.

P=N/A; Trial completion date: Jul 2024 --> Jul 2026 | Trial primary completion date: Dec 2022 --> Jul 2024

"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."

J.P. Morgan 41st Annual Healthcare Conference Presentation

P=N/A; N=120; Not yet recruiting; Sponsor:Grupo Espanol Multidisciplinario del Cancer Digestivo

"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."

P2/3 | "Support: U10CA180868, -180822; UG1CA189867; GuardantHealth. Clinical trial information: NCT04068103."

Through real-word data, we confirm prior studies showing multi-omic plasma-only MRD testing has high sensitivity and specificity for recurrence and now show use of the assay in clinical decision-making. Notably, methylation analysis and serial testing both improved detection of MRD and impacted clinical care. These findings should continue to be studied in larger cohorts and randomized trials.

Plasma-only genomic/methylation MRD detection with longitudinal sampling can predict recurrence in pts with stage I-III CRC without need for tissue analysis. NPV is high supporting an ACT de-escalation strategy in post-operative ctDNA negative pts, now investigated in the ongoing UK TRACC C randomised study (NCT04050345). Clinical trial information: NCT04050345.

P=N/A; N=80; Recruiting; Sponsor:Parc de Salut Mar

"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."

We demonstrate that the methylation signature used in Guardant Reveal Multi-Cancer panel is specific to the tumor fraction and independent of CH and age. In addition, the exploratory analysis based on a subset of samples shows comorbidities including asthma, COPD, and RA don't affect the methylation scores in the Reveal Multi-Cancer panel.

P=N/A; Trial completion date: Oct 2027 --> Feb 2028 | Trial primary completion date: Oct 2027 --> Feb 2028

"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."

Investor Presentation

"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...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."

ctDNA detection rates by a plasma-only multiomic MRD assay in this large CRC clinical cohort are similar to published rates. ctDNA orders by clinicians were most frequent in Stg II/III surveillance settings followed by PostOp, consistent with the population size of eligible patients for PostOp vs. Surveillance use-case.

"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."