PRECISION Study Highlights Potential of Guardant Liquid Biopsy Tests to Predict Colorectal Cancer Recurrence Risk After Surgery
Guardant Health, a precision oncology company focused on advancing cancer care through innovative blood-based testing technologies, has announced the publication of new clinical research findings in ESMO Open. The results come from the PRECISION study, a prospective, multicenter observational study conducted in Japan that evaluated the potential of combining two blood-based testing approaches to assess the risk of cancer recurrence in patients undergoing surgery for colorectal cancer metastases.
The study enrolled 130 patients and examined how comprehensive genomic profiling (CGP) before surgery and minimal residual disease (MRD) testing after surgery could provide complementary information about a patient’s cancer prognosis. Researchers evaluated Guardant360® Liquid before treatment and Guardant Reveal® approximately four weeks after surgery. By combining the results from these two tests, investigators identified three patient groups with significantly different recurrence-free survival outcomes.
The findings suggest that analyzing tumor-related genetic alterations before surgery alongside circulating tumor DNA (ctDNA) after surgery may help healthcare professionals better understand the risk of colorectal cancer returning. The approach could also support the development of more personalized treatment strategies for patients with advanced colorectal cancer, although further prospective interventional research will be needed to confirm its clinical value.
Study Examines Two Complementary Blood-Based Testing Approaches
The PRECISION study was designed to investigate whether blood-based genomic profiling before surgery and postoperative MRD assessment could provide useful prognostic information for patients with colorectal cancer metastases undergoing curative-intent surgery.
Colorectal cancer is a major global health concern, ranking as the third most common cancer worldwide and the second leading cause of cancer-related deaths. Although surgery can offer an opportunity for curative treatment in selected patients with metastatic disease, the possibility of recurrence remains an important concern.
Following surgery, clinicians must evaluate whether cancer cells may remain in the body and whether additional treatment could be beneficial. However, identifying patients at higher risk of recurrence can be challenging. Conventional approaches may not always provide sufficient information to distinguish patients who are likely to remain cancer-free from those who may experience disease progression.
The PRECISION study explored whether liquid biopsy testing could help address this challenge by providing information at two different stages of the treatment journey.
Before surgery, patients underwent comprehensive genomic profiling through Guardant360 Liquid. This blood-based test was used to identify genomic alterations associated with their cancer. Following surgery, patients were evaluated using Guardant Reveal, which was used to detect circulating tumor DNA as an indicator of possible minimal residual disease.
The combination of these assessments allowed researchers to examine whether pretreatment tumor characteristics and postoperative ctDNA detection could provide a more detailed understanding of recurrence risk than either assessment alone.
Guardant360 Liquid Identifies Genomic Alterations in Most Patients
One of the important findings from the study was the feasibility of pretreatment blood-based comprehensive genomic profiling.
Guardant360 Liquid successfully detected genomic alterations in 97% of patients evaluated in the study. This high detection rate demonstrated that blood-based genomic profiling was feasible for nearly all eligible participants.
The results also indicated that genomic information obtained before surgery could help identify patients with different levels of recurrence risk. Among the patients evaluated, 64% had genomic profiles associated with a greater than fourfold higher hazard of recurrence or death.
These findings highlight the potential importance of understanding the molecular characteristics of a patient’s cancer before surgical treatment. Genomic profiling can provide information about the genetic alterations present in a tumor and may help researchers investigate how those characteristics relate to subsequent clinical outcomes.
For patients with colorectal cancer metastases, identifying genomic features associated with poorer outcomes could become an important part of future risk-assessment strategies.
The study’s results suggest that pretreatment genomic profiling may offer valuable information that can be considered alongside postoperative assessments. However, the findings do not establish that genomic profiling alone can determine which patients should receive a particular treatment. Rather, they demonstrate its potential contribution to a broader approach to understanding recurrence risk.
Guardant Reveal Detects Minimal Residual Disease After Surgery
The second component of the study focused on postoperative minimal residual disease detection using Guardant Reveal.
MRD testing is designed to identify molecular evidence that cancer may remain in the body following treatment. In this study, Guardant Reveal was used approximately four weeks after surgery to evaluate the presence of circulating tumor DNA.
Postoperative MRD testing was evaluable in 99% of patients who underwent surgery, demonstrating that the blood-based approach could be successfully assessed in almost all surgical participants.
The test detected MRD in 31% of patients. Importantly, the presence of detectable MRD was significantly associated with worse clinical outcomes, corresponding to a 4.7-fold increase in the hazard of recurrence or death.
This finding reinforces the potential role of postoperative ctDNA analysis in evaluating recurrence risk. Even after surgery intended to remove cancer, some patients may remain at higher risk because microscopic disease could still be present.
Traditional imaging and other clinical assessments may not always identify very small amounts of residual cancer. Blood-based MRD testing offers another approach by examining ctDNA in the bloodstream.
The PRECISION findings indicate that postoperative ctDNA detection may provide important prognostic information for patients with colorectal cancer metastases. When considered together with pretreatment genomic profiling, it may help clinicians develop a more complete understanding of the patient’s disease.
Nevertheless, MRD detection should be interpreted within the broader clinical context. The study provides evidence of an association between detectable MRD and poorer outcomes, but it does not establish that changing treatment based on the test results will necessarily improve survival.
Combined Testing Identifies Three Distinct Recurrence-Risk Groups
A major contribution of the PRECISION study was its evaluation of pretreatment genomic profiling and postoperative MRD testing together.
Researchers found that combining the two assessments identified three distinct groups of patients with markedly different estimated two-year recurrence-free survival outcomes.
The results were as follows:
- Patients with neither adverse feature: Estimated two-year recurrence-free survival was 78%.
- Patients with one adverse feature: Estimated two-year recurrence-free survival was 40%.
- Patients with both adverse features: Estimated two-year recurrence-free survival was 9%.
These findings demonstrate the potential value of combining information collected before and after surgery.
Patients who had neither of the identified adverse features experienced the most favorable estimated recurrence-free survival. In contrast, patients who had both adverse features had the lowest estimated recurrence-free survival, indicating a substantially higher risk of cancer recurrence.
The group with one adverse feature had an intermediate outcome, suggesting that the combined approach could help distinguish different levels of risk rather than simply categorizing patients as either high-risk or low-risk.
This type of risk stratification may be particularly important in colorectal cancer care, where patients can experience different outcomes even when they undergo similar surgical procedures.
By identifying patients who may have a greater likelihood of recurrence, clinicians could potentially gain additional information when discussing follow-up strategies and considering future treatment approaches. Patients with more favorable results may also benefit from a clearer understanding of their postoperative risk profile.
However, the study’s findings should be viewed as prognostic evidence rather than proof that the testing strategy can independently guide treatment decisions. Further research is necessary to determine how these results can be translated into clinical practice.
Blood-Based Testing May Address Challenges Associated With Tissue Samples
Another important aspect of the PRECISION study is the potential advantage of liquid biopsy testing over certain tissue-based testing approaches.
Obtaining adequate tumor tissue for genomic analysis can be difficult in some clinical situations. Limited biopsy accessibility before treatment may prevent the collection of sufficient tissue samples. After surgery, tissue-based testing may also involve longer turnaround times, potentially delaying the availability of important information.
Blood-based testing offers an alternative approach by analyzing cancer-related genetic material circulating in the bloodstream.
In the PRECISION study, the use of Guardant360 Liquid before surgery and Guardant Reveal after surgery demonstrated the feasibility of evaluating patients at two different stages through blood samples.
The high evaluability rates reported in the study were particularly notable. Guardant360 Liquid detected genomic alterations in 97% of patients, while postoperative MRD testing was evaluable in 99% of patients who underwent surgery.
These results suggest that liquid biopsy approaches may help address some of the practical limitations associated with tissue-based testing in this patient population.
The two tests also served different purposes. Guardant360 Liquid provided pretreatment genomic information, while Guardant Reveal assessed postoperative MRD status. Their complementary roles allowed researchers to examine both the molecular characteristics of the cancer and the potential presence of residual disease following surgery.
This approach may be relevant to future research involving personalized cancer management, particularly when clinicians need to assess recurrence risk using information gathered at different points in the treatment process.
Principal Investigator Highlights Potential Clinical Significance
Shin Kobayashi, MD, PhD, of the Department of Hepatobiliary and Pancreatic Surgery at National Cancer Center Hospital East in Kashiwa, Japan, was a principal investigator of the PRECISION study.
Kobayashi noted that the clinical application of ctDNA analysis has developed significantly over the past decade. However, the clinical usefulness of combining preoperative comprehensive genomic profiling with postoperative MRD testing to guide perioperative treatment decisions in patients with resectable colorectal oligometastases has remained unclear.
According to Kobayashi, the PRECISION findings suggest that pretreatment tumor genomic profiling and postoperative MRD assessment may provide complementary prognostic information.
He highlighted the potential for this combined approach to help patients and their healthcare teams better understand the risk of recurrence following surgery. The findings could also contribute to the future development of more personalized treatment strategies.
At the same time, Kobayashi emphasized the need for prospective verification through an interventional study.
This qualification is important because observational research can identify relationships between test results and clinical outcomes, but it does not necessarily demonstrate that using those results to make treatment decisions will improve patient outcomes.
Further research will therefore be necessary to establish how the combined testing approach could be incorporated into treatment planning and whether it can support better clinical decisions.
Guardant Health Emphasizes the Role of Liquid Biopsy Across Cancer Care
Helmy Eltoukhy, chairman and co-CEO of Guardant Health, said the findings demonstrate how the company’s liquid biopsy technologies can provide a more comprehensive view of cancer and generate information that may benefit clinical practice.
He also emphasized the company’s commitment to supporting patients throughout the cancer care continuum.
Guardant Health develops precision oncology testing technologies intended to provide genomic and molecular information that can support cancer diagnosis, treatment selection, and disease monitoring.
The PRECISION study adds to the clinical research examining how blood-based testing can be used at different stages of cancer management.
By evaluating genomic alterations before surgery and MRD status after surgery, the research demonstrates a potential framework for collecting complementary molecular information during the treatment journey.
For patients with colorectal cancer metastases, recurrence remains an important consideration even after curative-intent surgery. The ability to identify patients with different levels of recurrence risk could become valuable as researchers explore more individualized approaches to postoperative care.
Further Research Needed to Establish Treatment Applications
Although the PRECISION results are encouraging, additional clinical research will be necessary before the combined testing strategy can be established as a routine method for guiding perioperative treatment decisions.
The study was prospective and multicenter, included 130 patients in Japan, and evaluated recurrence-related outcomes using two complementary blood-based approaches. Its results provide evidence that pretreatment genomic profiling and postoperative MRD detection can help identify patient groups with different prognostic outcomes.
However, the investigators have emphasized that the findings should be prospectively verified in an interventional study.
Future research will need to examine whether treatment strategies informed by these results can improve clinical outcomes. It will also be important to determine how the testing approach can be integrated into existing clinical pathways and how healthcare teams should interpret the results when considering postoperative management.
The distinction between identifying recurrence risk and proving that a particular intervention improves outcomes remains essential.
Advancing Personalized Colorectal Cancer Management
The publication of the PRECISION study in ESMO Open represents another development in research exploring the potential of circulating tumor DNA analysis in colorectal cancer management.
The study’s findings suggest that combining Guardant360 Liquid before surgery with Guardant Reveal after surgery may provide complementary information about recurrence risk in patients undergoing curative-intent surgery for colorectal cancer metastases.
With genomic alterations detected in 97% of patients, postoperative MRD testing evaluable in 99% of surgical patients, and three distinct risk groups identified through combined assessment, the research highlights the potential of liquid biopsy technologies to support more detailed prognostic evaluation.
The estimated two-year recurrence-free survival rates of 78%, 40%, and 9% across the three groups demonstrate the differences that may emerge when pretreatment genomic information and postoperative MRD status are considered together.
As colorectal cancer continues to represent a significant global health burden, approaches that improve the understanding of recurrence risk remain an important area of clinical research.
For Guardant Health, the PRECISION findings reinforce the potential role of liquid biopsy testing throughout the cancer care continuum. While further interventional studies are required to confirm the clinical applications of the approach, the research provides additional evidence supporting the investigation of blood-based genomic profiling and MRD assessment as complementary tools in personalized colorectal cancer care.
Source link: https://investors.guardanthealth.com/
