TEST:

Guardant360 Response™

P1/2; The following biomarkers were associated with better outcomes for patients treated with T-DM1 + neratinib: (1) ctHER2-amp (C1D1) or in TP1; (2) Molecular Response scores; (3) loss of detectable ctDNA; (4) RNA levels of HER2; and (5) on-treatment loss of detectable ctHER2-amp. HER2 transcriptional and IHC/FISH status identify HER2-low cases (IHC 1+ or IHC 2+ and FISH negative) in these heavily anti-HER2 treated patients. Due to the small number of patients and samples in this study, the associations we have shown are for hypothesis generation only and remain to be validated in future studies. Clinical Trials registration NCT02236000.

"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 today that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant360 Response test....Following this decision, the Guardant360 Response test is now covered for fee-for-service Medicare patients in the U.S. with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy. The coverage includes a Guardant360 CDx or LDT test before initiating therapy to establish a ctDNA baseline and a Guardant360 Response test 4 to 10 weeks after the therapy has been initiated to measure the change in ctDNA level."

These data demonstrate a statistically significant interaction between baseline ctDNA level and treatment-induced ctDNA level change in association with RW clinical outcomes. This facilitates the development of patient-based models incorporating baseline ctDNA level with ctDNA molecular response for association with RW clinical outcomes.

J.P. Morgan 41st Annual Healthcare Conference Presentation

Patients with aCRC classified as molecular responders, as calculated by this algorithm, had prolonged time on treatment and overall survival. Compared to tumor markers, ctDNA has a short half-life, which can allow for early response assessment, as shown by our study. These findings are relevant for clinical care, with future potential to allow for adaptive clinical trial design.

"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."

PADA-1 was designed to assess the clinical utility of sequential analysis of ctDNA for emerging ESR1 mutations to trigger an early switch from AI plus palbociclib to fulvestrant plus palbociclib treatment. Changes in ctDNA fraction during the first weeks of treatment are predictive of long term clinical benefit on an individual patient basis, particularly during the first year of therapy. Adjusting the MR threshold and/or limiting to genes known to be relevant in the specific tumor can tailor the assessment of ctDNA change to specific clinical scenarios where greater sensitivity or specificity may be required. The identification of patients at high risk for early clinical failure at the onset of treatment may allow for therapy escalation and/or change to improve outcome in this population.

Ethics Approval This research was approved by the Quorum Institutional Review Board (IRB) for the generation of de-identified datasets for research purposes. View this table: View inline View popup Download powerpoint Abstract 6 Table 1

"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 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."

Baseline plasma ctDNA genotyping correlated with tumor tissue based NGS in an NSCLC patient population with HER2 mutations. Poziotinib treatment resulted in mVAF reduction, which correlated with clinical response per RECIST1.1. Assessment of longitudinal changes in ctDNA during drug therapy may potentially be used to predict patient response and possibly tumor resistance.