Good news! Blood only liquid biopsy test can predict colorectal cancer recurrence

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https://www.businesswire.com/news/home/20210430005142/en/CORRECTING-and-REPLACING-Study-Shows-Guardant-Reveal™-Blood-Only-Liquid-Biopsy-Test-Predicts-Risk-for-Colorectal-Cancer-Recurrence-with-Industry-Leading-Sensitivity

CORRECTING and REPLACING Study Shows Guardant Reveal™Blood-Only Liquid Biopsy Test Predicts Risk for Colorectal Cancer Recurrence with Industry-Leading Sensitivity​

CORRECTION...by Guardant Health
June 18, 2021 08:23 PM Eastern Daylight Time

 

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REDWOOD CITY, Calif.--(BUSINESS WIRE)--Please replace the release dated April 30, 2021, with the following corrected version due to changes in the fifth paragraph.

The updated release reads:

STUDY SHOWS GUARDANT REVEAL™ BLOOD-ONLY LIQUID BIOPSY TEST PREDICTS RISK FOR COLORECTAL CANCER RECURRENCE WITH INDUSTRY-LEADING SENSITIVITY

For patients with early-stage colorectal cancer (CRC), the presence of circulating tumor DNA (ctDNA) or minimal residual disease (MRD) after curative intent treatment is becoming an important prognostic biomarker for cancer recurrence, and can also be used to evaluate the potential need for adjuvant treatment in post-surgical patients. Until recently, tests developed to detect MRD required tumor tissue to gain the necessary genomic information needed to accurately identify high-risk patients. A new study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrates that Guardant Reveal, the first blood-only liquid biopsy to identify MRD, identifies those patients most likely to recur, with industry-leading sensitivity, without the need for tumor tissue. 1,2

 

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The single-center, prospective study evaluated the effectiveness of the Guardant Reveal liquid biopsy test to detect MRD in patients with stage I-IV colorectal cancer after curative intent therapy. Blood draws were taken one month after completion of definitive treatment, either surgery or adjuvant therapy, and at various surveillance or monitoring timepoints. Blood samples were analyzed using the Guardant Reveal test, which integrates both cancer-specific epigenomic signatures and genomic alterations, unlike standard MRD tests which analyze only genomic alterations.

In the primary landmark analysis (n=84), blood samples were taken from the curative intent patient population one month (median 31.5 days) after completion of definitive treatment. In the subset of patients with at least one year of clinical follow-up, all patients with detectable ctDNA recurred (100% PPV). Guardant Reveal test sensitivity and specificity were 55.6% and 100% respectively for this single timepoint. By incorporating longitudinal surveillance samples, sensitivity improved to 91%. Integrating epigenomic signatures increased test sensitivity by 36% versus using genomic alterations alone. Additionally, CEA tests, the traditional biomarker for colorectal cancer, did not predict recurrence in this patient cohort.

 

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“The integration of cancer-specific epigenomic and genomic signatures allows Guardant Reveal to detect minimal residual disease in early-stage colorectal cancers with industry-leading performance and without the need for tumor tissue,” said AmirAli Talasaz, Guardant Health president. “We believe that Guardant Reveal can be a powerful decision-making tool for oncologists managing patients with early-stage colorectal cancer. In addition, our blood-only approach offers a more streamlined workflow and faster turnaround time for clinical decision making.”

“By detecting minimal residual disease after curative intent treatment, we can have a better understanding of which patients are at high-risk for recurrence and perhaps tailor additional therapy,” said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. “This study demonstrates that the incorporation of epigenomic signatures with genomic alterations allows for Guardant Reveal to have high sensitivity and specificity, but without the need for tumor tissue."

 

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Tissue-dependent MRD tests have previously reported sensitivities of 40%-50% with a single post-surgical blood draw. 1,3 When looking only at the subset of patients with stage II or III CRC in this study, Guardant Reveal had a sensitivity of 63% and a specificity of 100% for recurrence. These data show that Guardant Reveal can detect minimal residual disease from a simple blood draw. In addition, the sensitivity of the test increases with additional longitudinal blood draws, allowing for earlier detection of recurrence in the patient surveillance setting compared with standard imaging methods.

The Guardant Reveal test achieves industry-leading sensitivity (91%) 2 for detecting ctDNA by simultaneously interrogating genomic and epigenomic alterations. The test accurately identifies genomic alterations down to allele frequencies of 0.01% and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures is essential to increasing test sensitivity in the post curative intent and surveillance patient populations.

The publication titled, “Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients” can be found here.

 

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About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets, and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched liquid biopsy-based Guardant360 ®, Guardant360 CDx, and GuardantOMNI ® tests for advanced stage cancer patients, and Guardant Reveal ™ test for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

 

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https://www.fool.com/investing/2020/10/17/is-guardant-health-stock-a-buy/

The treatment of cancer is still in the early phases of a sea change, as scientists design unique treatments for cancers with specific genetic characteristics. Precision oncology is increasingly reliant on understanding the genetic code of each patient's cancer, but that information is often difficult or dangerous to obtain through a biopsy of the tumor itself. Guardant Health is a technological leader in detecting tumor DNA circulating in the bloodstream (known as ctDNA, or circulating tumor DNA), and the advantages of that technique opens up a huge potential market for the company, broken down into these three market segments.

 

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Therapy selection in advanced-stage cancer patients​

Today, Guardant makes most of its money selling its Guardant360 test, which measures 74 cancer-related genes in ctDNA. Oncologists use this information to select the proper treatment for patients with metastatic cancer, and pharmaceutical companies buy the test for use in research and clinical trials.

The company scores big wins when the test gets selected as the companion diagnostic for a specific cancer drug, as it has been for a lung cancer drug from AstraZeneca, and continued growth will be driven by more of these collaborations. The test is being evaluated as a companion diagnostic for other forms of lung cancer and for breast cancer, and recently became the first liquid biopsy to be approved by the U.S. Food and Drug Administration for tumor mutation profiling across all solid cancers.

 

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The company also sells GuardantOMNI, a much broader test of 500 genes in ctDNA that's used by pharma companies in researching new cancer drugs. Guardant thinks the potential market for therapy selection applications of its tests is $6 billion.

Supplemental treatments in early-stage cancer patients and surveillance in survivors​

The market for Guardant's products gets much bigger when they are used earlier in the diagnosis and treatment of disease. Early-stage cancer patients are sometimes given chemotherapy to shrink the tumor before surgical removal, a treatment known as neoadjuvant therapy. Adjuvant therapy, or the administration of chemotherapy after surgery to kill any remaining cancer cells, is also a common practice. Guardant has developed its LUNAR-1 assay to help oncologists identify which patients will benefit from neoadjuvant or adjuvant therapy, and as a tool for recurrence monitoring.

Today, LUNAR-1 is just sold for research purposes but if clinical tests are successful, these applications in early-stage cancer will provide a substantial boost to the company's growth. Guardant estimates the market opportunity to be more than twice its currently addressable market, at $15 billion.

 

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Early detection of cancer​

The really big prize that Guardant -- along with a number of competitors -- is chasing, though, is early detection of cancer in asymptomatic patients. The first step for the company will be its LUNAR-2 test as a screening tool for colorectal cancer (CRC).


Colonoscopies will remain the gold standard for CRC screening, since physicians can detect and remove pre-cancerous polyps before the disease gets a chance to develop in the first place. And stool-based tests such as Cologuard from Exact Sciences are established, but over 30% of the U.S. population who should be screened don't stay up to date with their tests, avoiding colonoscopies and not following through with stool-based tests. Guardant hopes to make its LUNAR-2 liquid biopsy part of the regular menu of blood tests patients get in office visits, meeting a need for a screening technique that doesn't rely on initiative by the patient.

LUNAR-2 is in a clinical trial for CRC screening, but the company is also anticipating developing LUNAR-2 tests for early detection of multiple cancer types in high-risk individuals such as smokers or people with hereditary risk factors. The potential market for these screening tests is a whopping $33 billion, according to Guardant.

 

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Competitive risks, but plenty of opportunity​

Guardant faces growing competition in the space for liquid biopsy, which is no surprise given the enormous opportunity. The latest development is the acquisition of Grail by Illumina, meaning the maker of the gene sequencing machines Guardant Health uses will be encroaching on its testing space. Grail is working on early detection as well as recurrence monitoring and is expected to launch its first blood test for detecting cancer in asymptomatic patients next year. This will be significant competition for Guardant in its target markets in the long run, but in the next few years, the higher visibility of liquid biopsy may actually help Guardant win acceptance for its own products.