Guardant360 CDx Liquid Biopsy: Revolutionizing Genomic Profiling with FDA Approval for 55 Genes

The world of precision medicine has experienced unprecedented growth over the past decade, and innovation has changed how patients are treated. One such breakthrough is the Guardant360 CDx, a new liquid biopsy test developed by Guardant Health. The US Food and Drug Administration (FDA) recently approved the test for comprehensive profiling of 55 genes, further expanding its capabilities in cancer diagnosis, prognosis, and treatment selection.

What is Guardant 360 CDx?

Guardant360 CDx is a non-invasive in vitro diagnostic device based on next-generation sequencing. It uses a small amount of blood to test for changes in 55 cancer-related genes. The test is designed to detect the presence of specific gene mutations and changes in patients’ tumor DNA circulating in their blood, also known as circulating tumor DNA. This breakthrough technology eliminates the need for invasive tissue biopsy, providing patients with a more comfortable and potentially safer alternative. The liquid biopsy test is designed to provide physicians with a comprehensive genomic profile of a patient’s cancer for personalized treatment decisions.

For What Types of Cancer Is Guardant 360 CDx Used?

The test is designed to detect changes in 55 different genes known to be associated with cancer. By identifying these changes, a next-generation biopsy can provide valuable information about a patient’s cancer genomic profile, which can be used to make treatment decisions. The US Food and Drug Administration (FDA) has approved the Guardant 360 CDx for two specific purposes:

• Tumor mutation profiling, also known as comprehensive genomic profiling: in this case, Guardant 360 CDx is used in all solid cancers (e.g., lung, breast, colorectal, prostate, etc.) to identify patients who may benefit from targeted therapy in accordance with the approved labeling of the therapeutic product. This means that the test could detect changes in a wide variety of cancers if those changes are associated with FDA-approved targeted therapies.
• Supportive Diagnostics: The FDA has specifically approved the Guardant 360 CDx as an assistive diagnostic tool to identify non-small cell lung cancer (NSCLC) patients who may benefit from treatment with osimertinib (Tagrisso), a targeted therapy. In this role, the test detects specific mutations in the epidermal growth factor receptor (EGFR) gene, known as exon 19 deletions or exon 21 replacement mutations (L858R).

It is important to note that while the Guardant 360 CDx test can provide valuable information for treatment decisions, it does not replace traditional biopsy or other diagnostic procedures. On the contrary, it provides an additional tool that physicians can use to understand the genetic makeup of a patient’s cancer, especially in situations where tissue biopsy may not be possible or a complete genomic profile is required.

Remember that the field of oncology is evolving rapidly, with new diagnostic tools and treatments constantly being developed. Always refer to the latest information from trusted medical sources or consult a healthcare professional for the most up-to-date and personalized advice.

How Is Guardant 360 CDx Liquid Biopsy Performed?

This type of biopsy is performed with a simple blood draw, making it a non-invasive alternative to traditional tissue biopsy. The main steps in the process are listed below:

• A blood sample is taken from the patient, usually from a vein in the arm. It is collected in a special tube included in the Guardant360 CDx kit. Blood sampling can be done in a clinical setting, such as a doctor’s office or phlebotomy laboratory.
• The resulting biomaterial is then sent to the CLIA-certified and CAP-accredited Guardant Health laboratory for analysis. The sample must be sent promptly and stored at the correct temperature to keep the material viable for analysis.
• In the laboratory, plasma is separated from a blood sample using a process called centrifugation. Cell-free DNA is then released from the plasma, which includes circulating tumor DNA (ctDNA).
• The isolated ctDNA is then prepared for sequencing. This includes end repair, adapter ligation, and amplification to prepare DNA fragments for sequencing.
• A unique barcode is also added to each piece of DNA to ensure accurate tracking. The prepared DNA is then sequenced using next-generation sequencing technology. It allows multiple genes to be sequenced simultaneously, providing a comprehensive view of genomic changes in ctDNA.
• The data is analyzed using bioinformatics algorithms to identify and report changes in the 55 genes covered by the Guardant 360 CDx test. The test detects single nucleotide variants, insertions and deletions, copy number changes, and fusions.
• A report is generated that describes the detected genomic changes. Then it is sent to the doctor who ordered the study.
• The physician interprets the results in the context of the patient’s clinical situation and can use the information obtained to make treatment decisions. This may include selecting targeted therapy, considering participation in clinical trials, or monitoring disease progression or response to treatment.

The turnaround time for the test is around seven days from the time the sample is received in the laboratory, providing doctors and patients with timely information to make treatment decisions.

Benefits of Liquid Biopsy

Guardant360 CDx has several advantages over traditional tissue biopsy and other diagnostic methods in oncology:

• Since the test only requires a blood draw, it is much less invasive than a traditional tissue biopsy, which can be a more complex procedure involving surgery or interventional radiology. This may be especially helpful for patients not candidates for conventional biopsy due to health risks, tumor location, or other factors.
• The typical turnaround time for Guardant 360 CDx is around 7 days from when the sample is received in the lab. This could speed up treatment decisions, which is critical given the aggressive nature of many cancers.
• The test analyzes 55 cancer-associated genes for changes, providing a comprehensive view of a patient’s genomic landscape of oncology. This helps identify potential targets for therapy that may not have been detected by a single gene test or a smaller panel of genes.
• The report generated from the test results not only identifies the genetic changes present in the tumor but also contains a list of FDA-approved treatments for those changes. This can help oncologists choose the most appropriate treatment for the patient.
• Like a liquid biopsy, Guardant 360 CDx can be used repeatedly to monitor disease progression or response to treatment. This is more problematic with tissue biopsies, usually not performed multiple times.
• In some cases, obtaining sufficient tumor tissue for genomic profiling may be difficult, especially in patients with advanced disease or certain tumor sites. In such cases, liquid biopsy may be an alternative way to obtain such important information.
• Tumors are often heterogeneous; that is, they contain different populations of cancer cells with different genetic changes. A tissue biopsy may miss some of these populations because only a small portion of the neoplasia is taken. Still, a liquid biopsy can provide a more complete picture of the tumor’s genetic landscape.

Since the development of the Guardant 360 test, it has been widely used to detect beta particles in the blood and has received more than two hundred positive reviews. So far, more than 150,000 blood tests have been performed with the Guardant 360, saving tens of thousands of lives. 

How Much Does Guardant360 CDx Liquid Biopsy Cost?

This revolutionary diagnostic tool has shown its potential to transform the field of oncology, from helping with initial diagnosis to developing personalized treatment strategies and even monitoring disease progression or response to therapy.

However, innovative healthcare technologies often come with high costs, and the Guardant 360 CDx is no exception. The list price for this test was $7,900. It is important to note that this is a baseline cost, and actual patient costs can vary significantly depending on several factors (type of treatment, costs of additional therapies, hospitalization, etc.).

While the cost of the test is significant, it is also important to weigh it against the potential benefits. By providing a detailed genetic profile of a patient’s cancer, the Guardant 360 CDx test can help target treatments that may be more effective and potentially cause fewer side effects than conventional chemotherapy. The information obtained from the test can also be invaluable when tissue biopsy is impossible or when a complete understanding of the tumor’s genetic makeup is required.

In Which Countries Is Guardant 360 CDx Liquid Biopsy Performed?

Liquid biopsy has become an essential part of the healthcare infrastructure in many developed countries worldwide. Focusing on the landscape of modern medical diagnostics, it should be noted that significant progress has been made by countries such as Turkey, Israel, Spain and, Germany, the USA.

In these countries, liquid biopsy has been integrated into the healthcare system, playing a vital role in the early detection and treatment of cancer. These nations are at the forefront of developing this technology, investing heavily in research and development and setting a benchmark for other countries to emulate.

In Which Clinics Can I Undergo a Liquid Biopsy?

Sourasky Medical Center (Ichilov)

This is a well-known healthcare institution located in Israel. The country has made significant progress in cancer treatment, applying various effective strategies to combat this disease. One of the notable advances in cancer diagnosis and monitoring is a liquid biopsy.

At the Sourasky Medical Center, liquid biopsy has become integral to comprehensive cancer treatment. Using this advanced technique, they can identify specific genomic changes associated with different types of cancer. This information helps tailor treatment plans to individual patients and allows for personalized and targeted therapy.

Anadolu Medical Center

The introduction of liquid biopsy in cancer treatment at Anadolu reflects their commitment to the latest advances in medical technology. Through effective oncology treatments and the introduction of liquid biopsy, the medical specialists of this institution strive to provide patients with the best results in the fight against cancer.

Anadolu Medical Center is an outstanding medical facility located in Turkey. Known for its comprehensive oncology services, the clinic offers several noteworthy features in cancer treatment:

• Multidisciplinary approach.
• Advanced technologies and infrastructure.
• Robotic Surgery.
• Clinical trials and research.
• Individual treatment plans.

The clinic has a dedicated International Patient Service Department catering to the special needs of patients from abroad.

Memorial Hospital Group

The Memorial Clinics Network has introduced an innovative “Liquid Biopsy” procedure. Memorial Clinic Network is known for its commitment to implementing the latest medical advances:

• Hi-tech.
• Experienced medical staff.
• An integrated approach to treatment.
• Patient-centered care
• Research and development.

Memorial has received numerous accreditations that testify to the quality and standards of its service. Among them are accreditations from the Commission on Cancer (CoC), the National Accreditation Program for Breast Treatment Centers (NAPBC), the Joint Commission, and others. Each department has the most modern equipment, ensuring quality patient care. The diagnostic accuracy is 99.9%.

Nordwest Hospital

The Nordwest Medical Center, located in Germany, is a well-known medical institution with notable achievements in oncology. The clinic is distinguished by advanced and comprehensive cancer treatment using innovative methods such as liquid biopsy. The clinic is at the forefront of precision medicine, which involves selecting treatment based on the specific genetic profile of each patient’s tumor.

Using advanced genome sequencing and analysis, Nordwest Medical Center identifies specific tumor genetic changes, allowing targeted therapies and personalized treatment regimens. Precision medicine increases the effectiveness of treatment and minimizes side effects.

Teknon Medical Center

The medical center, located in Spain, offers exceptional opportunities in oncology. The clinic stands out for its specialized expertise and use of liquid biopsy. Teknon Medical Center performs a non-invasive analysis of blood samples to detect cancer-associated genetic mutations. This allows personalized treatment plans and real-time monitoring of tumor characteristics.

Combined with the center’s renowned oncologists, these advanced techniques provide advanced and personalized care for cancer patients.

This is only part of the list of clinics where Guardant 360 CDx liquid biopsy is performed. To clarify the information, you can always contact the coordinators of the Clinics On Call service.

Summary

In conclusion, liquid biopsy has revolutionized the field of oncology by providing a non-invasive and efficient method for detecting and monitoring genetic mutations. This innovative approach offers personalized treatment options, real-time monitoring of tumor characteristics, and the ability to detect cancer recurrence early.

Due to its many advantages over traditional tissue biopsy, liquid biopsy is promising to improve patient outcomes, target therapies, and advance our understanding of cancer. As technology advances further, liquid biopsy has the potential to play a critical role in the future of cancer diagnosis and treatment.