TEST:

GuardantREVEAL

"Guardant Health, Inc...today announced new data demonstrating that its Guardant Reveal® blood test helps clinicians to assess the effectiveness of chemotherapy in patients with advanced solid tumors months earlier than conventional methods. This is the first robust clinical validation study of pan-cancer chemotherapy monitoring, published in the Journal of Liquid Biopsy. The study used a tissue-free, methylation-based ctDNA tumor fraction signal to track changes in cancer over time and provides real-world evidence that changes detected in a blood-based tumor signal correlate strongly with patient outcomes, offering oncologists a timely and non-invasive tool for monitoring cancer therapy."

P=N/A, N=2020, Recruiting, Guardant Health, Inc. | N=1050 --> 2020 | Trial completion date: Feb 2028 --> Aug 2029 | Trial primary completion date: Feb 2028 --> Aug 2029

Among 627 stage IV cancer patients receiving SoC ICI, monitoring with methylation-based TF identified patients who have significantly longer rwPFS and rwOS. Changes in TF on ICI can provide additional response data earlier than imaging alone and support the potential of serial monitoring to inform treatment decisions.

ctDNA detection after surgery/radiation in oligometastatic CRC predicts worse OS and DFS. ctDNA could help to guide the decision regarding need of adjuvant chemotherapy in this population.

Baseline and on-treatment ctDNA dynamics may provide an early indication of benefit from letrozole/abemaciclib in EC. ctDNA at the time of progression may identify resistance alterations that may inform subsequent therapy.

In early-stage TNBC patients, a tissue-free, epigenomic assay and demonstrated high specificity and sensitivity for metastatic recurrence. ctDNA detection in the neoadjuvant setting indicated poor prognosis, highlighting its potential role across breast cancer care.

Guardant Health, Inc...today announced that Palmetto GBA, a Medicare administrative contractor that administers the Molecular Diagnostics Services program (MolDX), granted coverage for the Guardant Reveal test to monitor for disease recurrence in patients with colorectal cancer (CRC) following curative intent therapy. Guardant Reveal, which runs on Guardant’s Smart Liquid Biopsy platform, is a blood test that uses epigenomic (methylation) analysis to detect circulating tumor DNA (ctDNA), a marker of minimal residual disease (MRD), to predict cancer recurrence, helping to guide clinical decisions after surgery or chemotherapy.

"Guardant Health, Inc...today announced that a jury in the U.S. District Court for the Northern District of California (the “Court”) unanimously found in favor of Guardant Health on all of its claims from its May 2021 lawsuit against Natera, Inc. (Nasdaq: NTRA) (“Natera”) for false advertising and unfair competition. The jury awarded $292.5 million to Guardant Health, including $175.5 million in punitive damages, representing one of the largest false advertising verdicts in history. The jury unanimously rejected all of Natera’s counterclaims."

Methods The phase II PELOPS trial (NCT02764541) enrolled pts with clinical stage I-III HR+, HER2-negative BC and randomized to NET plus palbociclib or NET alone for 24 weeks prior to surgery; plasma samples were collected at baseline (BL) and prior to surgery (PS)...These results are limited by the sample size but warrant further investigation of the role of ctDNA as a tool to predict sensitivity to ET and long term outcomes. Such a tool could be valuable in tailoring treatment approaches, particularly given the ongoing development of novel ETs and the addition of CDK4/6i in the adjuvant setting.

Our analysis suggests the utility of a tissue-free ctDNA assay in diagnosing minimal residual disease. This could have clinical implications by enabling earlier diagnosis and possibly intervention to delay or prevent metastatic recurrence. We confirm prior studies showing high specificity for recurrence detection with multi-omic plasma-only MRD testing.

She remained with no evidence of disease on tucatinib, trastuzumab, and capecitabine for over 19 months but developed severe hand-foot syndrome...The pt's capecitabine dose was increased, and letrozole was added as her resected brain metastasis showed positive progesterone receptor expression... This study describes real-world use and results of a tissue-free monitoring test in early-stage BC. The high QC pass rate (99.9%) and rapid 10-day TAT support the feasibility of a tissue-free assay for MRD detection. Results suggest a potential provider preference for monitoring for patients with stage III BC, TNBC, and HR-/HER2+ BC.

P=N/A; Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2024 --> Apr 2025