What Liquid Biopsy Tests Are Fda
FDA-approved tests have been thoroughly researched to ensure theyre safe and accurate. Several liquid biopsy tests are under development and in various stages of research. Four are FDA-approved:
- Cell Search® Circulating Tumor Cell Test detects CTCs. Its used to predict the likely outcome for people with metastatic breast, prostate or colon cancer. It can help your provider monitor your condition. Few CTCs in the blood are a sign of a favorable prognosis. Many CTCs in the blood are a sign of an unfavorable prognosis.
- cobas® EGFR Mutation Test v2 detects ctDNA. It detects a mutation on the EGFR gene thats common in non-small cell lung cancer . This information can help your healthcare provider decide which types of treatments will work best to target the cell error.
- Guardant360® CDx detects ctDNA. Its also used to detect common genetic errors. It can help your provider choose the most effective treatments.
- FoundationOne® Liquid CDx detects ctDNA. It detects mutations in various cancers that can help your provider determine which treatments might work best.
Early Detection And Risk Re
PSA testing is not suitable for population-based screening due to its low specificity for prostate cancer, resulting in massive over-treatment and misdiagnosis. Multiparametric magnetic resonance imaging has improved the current prostate cancer diagnostic pathway but distinguishing aggressive cancers that require immediate and intense treatment from cancers that do not remains challenging. A number of tissue-based molecular tests have been implemented to distinguish aggressive cancers . Tissue-based tests could be complemented by liquid biopsies that by identifying tumour in circulation, confirm cancers potential for spread.
ctDNA has shown promising evidence of detecting clinically relevant, minimal residual disease after primary treatment in many tumour types . Studies in multiple cancer types have consistently shown that individuals with detectable ctDNA shortly after surgery relapsed sooner than those who were ctDNA-negative. These approaches used high-sensitivity analysis, either of recurrent mutations or patient-specific clonal mutations. Around 15% of localised prostate cancer patients eventually relapse after curative treatment . However, this is often detected by a rising PSA and a ctDNA based assay would have to improve on the performance of PSA for detecting minimal residual or early recurring disease.
About Dr Dan Sperling
Dan Sperling, MD, DABR, is a board certified radiologist who is globally recognized as a leader in multiparametric MRI for the detection and diagnosis of a range of disease conditions. As Medical Director of the Sperling Prostate Center, Sperling Medical Group and Sperling Neurosurgery Associates, he and his team are on the leading edge of significant change in medical practice. He is the co-author of the new patient book Redefining Prostate Cancer, and is a contributing author on over 25 published studies. For more information, contact the Sperling Prostate Center.
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Response Assessment And Outcome Surrogacy
Additional to patient selection, liquid biopsies have potential for real-time tracking of treatment response and early detection of progression. For example, in studies of men with high burden relapsed metastatic prostate cancer, CTC count included in a composite panel with serum lactate dehydrogenase is a surrogate of survival and captures the effect of ARSI treatment . Another study explored the CTCs dynamics in different end-points on over 6000 mCRPC patients enrolled in five Phase III clinical trials and showed its superiority in comparison to PSA responses. In fact, patients with over 1 CTC at baseline and zero at week 13 and patients with more than 5 CTCs and less than 4 at week 13, showed the longest overall survival . There are also studies that have tested this question for ctDNA. For example, in a cross-over study of abiraterone vs enzalutamide in mCRPC, patients with a baseline ctDNA fraction greater than 2% were associated with worse time to PSA progression . In patients responding to ARSI, samples taking while responding to therapy had a much lower ctDNA than the baseline sample . Other studies are testing ctDNA and other liquid biopsy features for assessing response and preliminary data from analysis of samples after 48 weeks of treatment is promising for distinguishing treatment response from primary resistance .
Bringing A Test To Market
In the last several months, based on research from Vogelstein and others, pharmaceutical companies have announced their intent to develop liquid biopsies for clinical use. Ive been pleased and delighted to see some large companies getting interested in this, Vogelstein says. They see the value. Once you see industry get into something, you can be much more certain that its going to make its way to the clinic.
For pancreatic cancer patients, a viable test would arrive not a moment too soon.
So much research now is directed at finding therapies, but prevention can reduce deaths, too, says Vogelstein. We want to catch these cancers earlier to make treatment more effective.
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Liquid Biopsy Demonstrates Clinical Utility In Advanced Prostate Cancer
A new study assessed the genomic alterations identified by ctDNA analysis compared with tissue-based comprehensive genomic profiling in patients with metastatic castration-resistant prostate cancer.
A new study from Foundation Medicine, Inc. and collaborators showed that the landscape of genomic alterations found using next-generation sequencing of circulating tumor DNA via liquid biopsy demonstrated high concordance with targetable alterations identified with tissue-based comprehensive genomic profiling in patients with metastatic castration-resistant prostate cancer .1
An estimated 1 in 8 men will be diagnosed with prostate cancer, the second-most common cancer in American men, in 2021.2 In patients with mCRPC, cancer grows and metastasizes despite treatment with androgen-deprivation therapy.
The study, published online in Clinical Cancer Research, aimed to assess the clinical validity of the genomic alterations detected in ctDNA from patients plasma using minimally invasive liquid biopsy. Researchers also compared the mutation landscape detected by ctDNA NGS with that of tissue-based CGP. The findings will also be presented at the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium on Thursday, February 11.
References
2. Key Statistics for Prostate Cancer. American Cancer Society. Updated January 12, 2021. Accessed February 9, 2021.
Blood And Urine Liquid Biopsy Tests In Prostate Cancer
David Albala, MD: I want to focus on the markers we use to determine whether patients should have a biopsy. Over the last couple of minutes, Ive tried to give an overview of where we are, but I want to drill down a little so we can talk about the blood and urine tests. Why dont we start with the urine tests, because you gave a great description of the PCA3 test. Maybe you could tell us about exosomes, what they are, and how is the ExoDx test useful?
Judd W. Moul, MD: We started using the exosome ExoDx test close to 2 years ago. I wanted a urinary replacement for PCA3 because I needed a secondary blood test. But it was important to have a urine test as well. Ill be honest, at first I was thinking more practically, that I needed a secondary blood test and a urine test, and not necessarily looking at the sensitivity and specificity. Maybe I should have looked at that first. And when you do an exosome ExoDx test, you made the key point that you dont need to do the rectal exam. With PCA3, which we had used before, you had to do an attentive digital rectal exam prior to the urine test. It wasnt a big deal, but it was a bit of a hassle. With the exosome ExoDx test the patients would give a first voided urine through a special device. We initially did it in house, meaning the patients would give the urine sample in the clinic, or in 1 of the exam rooms.
David Albala, MD: Thats a great point.
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Treatment Response Prediction And Assessment In Advance Disease
The role of liquid biopsies is better established in advanced metastatic disease where tumour volumes and circulating tumour are higher. Moreover, the clinical need for the selection of patients for targeted treatment has followed drug development pathways with current indications focused on relapsed patients. Several companies have developed multigene targeted-capture NGS assays, intended for cfDNA analysis, covering single-nucleotide variants , insertion or deletions and copy number alterations to detect a range of genomic aberrations at low allelic frequencies, primarily to provide tumour mutation profiling . More relevant to prostate cancer, is the recent FDA clearance of a liquid biopsy test for the selection of patients harbouring alterations in DNA damage repair genes, for example, the FoundationOne® Liquid CDx that was developed as a companion diagnostic for the PARP inhibitors rucaparib and olaparib in metastatic castration-resistant patients . This hybridisation-based NGS panel captures 300 genes including mutations in BRCA1 and 2.
cfDNA testing without concurrently sequencing the patients whole blood as control could uncommonly identify alterations in DDR genes that are presumed to be pathogenic but are clonal haematopoiesis of indeterminate potential variants. These false positives could lead to inappropriate treatment of patients with PARPi without the expected efficacy .
How Accurate Is A Liquid Biopsy
FDA-approved liquid biopsies effectively do what they say they do. CTC tests allow your healthcare provider to predict your prognosis and monitor your condition. ctDNA tests can identify genetic errors in cancer cell DNA, guiding your providers treatment decisions.
A liquid biopsy isnt always reliable when it comes to diagnosing cancer. A standard biopsy is needed to confirm a cancer diagnosis.
A note from Cleveland Clinic
Liquid biopsy tests are an active area of research and development because of their potential to help providers diagnose and monitor cancer with a simple blood test. Research is underway to develop liquid biopsy tests that can do things traditional biopsy procedures cant do, like detect cancer before a tumor has formed. Still, more research is needed to understand the potential uses of liquid biopsy. They can detect certain cancers and inform treatment decisions in particular situations. In the future, they may have many more uses.
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Prostate Cancer Detection Gets Help From Liquid Biopsy Chip
Prostate cancer is the second most common type of cancer among men. In 2018 alone, about 1.27 million new cases were registered, almost 360,000 patients died. Currently, there are two methods usually used to prove the diagnosis: the prostate-specific antigen blood test and the tissue biopsytaking the tissue samples for analysis. Both methods have significant drawbacks. Now, a team of investigators led by scientists at Sechenov University utilized microfluidics technology to develop a device able to isolate cancer cells from the urine of patients with prostate cancer.
Findings from the new studypublished recently in Cancers through an article entitled Rapid and Label-Free Isolation of Tumor Cells from the Urine of Patients with Localized Prostate Cancer Using Inertial Microfluidicsshowed high sensitivity and specificity of the new method in diagnosing prostate cancer.
Isolation of circulating tumor cells via blood liquid biopsy of prostate cancer has attracted significant attention as an alternative, or substitute, to conventional diagnostic tests, the authors wrote. However, it was previously determined that localized forms of PCa shed a small number of cancer cells into the bloodstream, and a large volume of blood is required just for a single test, which is impractical. To address this issue, urine has been used as an alternative to blood for liquid biopsy as a truly non-invasive, patient-friendly test.
Limitations Of Liquid Biopsies
Recent developments in non-invasive diagnostic and monitoring tools such as LBs have gained widespread attention in cancer treatment. However, LBs are not yet considered a standard tool for confirming and diagnosing different diseases, including cancer, and are primarily used as a complementary test to tissue biopsy. The major limitation of LB is the lack of sensitivity and precision to identify various tumor types compared to tissue biopsy. Moreover, it is also unclear whether LB provides a representative sampling of all genomic clones within an individual tumor or a specific sub-region of the tumor. It is pertinent to mention that diverse features of clonal evolution of tumors such as development of drug resistance, changes in genome, gene expression, epigenetics have been to a great extent successfully addressed by methods such as Single-Cell analysis of cancer cells . In addition, the number of CTCs, ctDNA, RNA, progenitor and mature endothelial cells, and tumor-educated platelets are relatively rare compared to other hematological components in the blood, which makes the detection ability of LBs challenging .
Undoubtedly, LB is an efficient non-invasive diagnostic method that can provide comprehensive tumor-molecular profiling and real-time information on therapeutic cancer targets, but there is a need to develop novel techniques and standardized approaches to overcome the limitations that hamper the implementation of LB into translational and clinical practice.
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Who Should Consider Having The Selectmdx Liquid Biopsy Test
SelectMDx Liquid Biopsy is a test dedicated to men with elevated PSA levels interested in prostate cancer prevention. The test determines the risk of discovering aggressive prostate cancer during a prostate biopsy and thus enables the Patient to make an informed decision regarding the necessity of having to undergo this procedure.
Please contact HIFU CLINIC Prostate Cancer Centers Medical Team via our free preliminary online consultation, to determine whether you are a suitable candidate for the SelectMDx Liquid Biopsy test.
What Was The Main Finding Of The Study
We looked at 221 blood specimens that had been drawn from 179 patients with metastatic prostate cancer who were about to begin treatment with either abiraterone or enzalutamide or a type of chemotherapy drug called a taxane.
This study found that patients with more diverse or heterogeneous cell populations did not respond as well or live as long after treatment with a hormone drug relative to patients whose CTCs were more homogenous.
This makes sense because the hormonal agents are more targeted, and a diverse population of cells may contain many cancer cells lacking that target. In contrast, the level of heterogeneity did not appear to affect response to chemotherapy.
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Clinical Applications Of Ctcs In Prostate Cancer
2.2.1. Enumeration: CTC Numbers as a Biomarker of Disease Activity
CTC enumeration has been extensively evaluated in localized and advanced prostate cancer states. In localized disease, initial hopes that identification of CTCs may predict disease recurrence were not realized. Davis et al. examined men with localized prostate cancer undergoing radical prostatectomy. Less than 5% had greater than 2 CTCs, and no correlation was found between CTC count and tumor volume, pathological stage, or Gleason score . In another study utilizing the CellSearch enrichment platform, CTCs were detected in just one of twenty patients with high-risk localized prostate cancer . Overall, CTC detection rates have varied between 5 and 52% in various studies of men with localized prostate cancer . No study to date has demonstrated a significant correlation between CTC enumeration and Gleason score, tumor stage or PSA in the pre- or early postoperative time frames. Though enumeration in the localized setting has not proven clinically beneficial, further characterization of CTCs, when identified in this setting, may offer relevant clinical applications as discussed later .
2.2.2. Liquid Biopsy in Practice: Identifying Phenotypes Through CTC Characterization
Current Technologies For Ctdna Analysis From Liquid Biopsies
The relative comparison of data from several sources is still a major hurdle in ctDNA analysis in clinical usage, as methods of sample handling, ctDNA isolation, and analysis have not yet been fully standardized, and a complete analytical consensus is lacking. The observed variations in both the quantity and the quality of ctDNA must be attributable to biological changes accompanying the tumor and not to the artifacts generated due to variation in sample handling. Studies have therefore focused on analyzing the effects of various preanalytical factors like clotting , DNA leakage from WBCs and hematopoietic cells , freeze-thawing, DNAse activity of blood , PCR compatibility of reagents , the time-lapse between blood drawing and analysis , and temperature in ctDNA analysis. Limitations associated with isolation and analysis of extremely low levels of ctDNA have to a large extent been reduced by ever-evolving technological applications .
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Clinical Applications Of Cfdna In Prostate Cancer
Quantification of cfDNA, especially in the context of temporal changes, offers a means of evaluating tumor burden and response to therapy. A retrospective study analyzed the prognostic significance of cfDNA concentration among men with CRPC prior to initiating chemotherapy and found elevated cfDNA concentration to be associated with poor PSA response and to act as an independent predictor of overall survival on multivariate analysis . Likewise, analysis of cfDNA levels in men with CRPC during chemotherapy in conjunction with serial imaging for treatment response monitoring demonstrated a significant positive relationship between cfDNA levels and tumoral activity as determined by PET/CT . Just as CTC enumeration reflects disease burden and prognosis, ctDNA quantification can reveal disease burden with potentially even greater sensitivity. By applying an immunospot assay for CTC detection and a PCR-based analysis with a panel of 14 polymorphic markers for detection of allelic imbalances on cfDNA, researchers found a significant relationship between the presence of CTCs and ctDNA levels with meaningful correlation to both tumor stage and Gleason score .
Liquid Biopsies For Prostate Cancer
A physical exam with a digital rectal exam, a PSA blood test, a prostate biopsy and a prostate MRI are the current keystones to the diagnosis of prostate cancer and its proper staging.
But clinicians now also use liquid biopsies in prostate cancer screening, said S. Adam Ramin, M.D., a urologic surgeon and the medical director of Urology Cancer Specialists in Los Angeles.
Ramin explained that liquid biopsies are used as a screening test to detect RNA strands in urine that are known to be functioning when prostate cancer is present. Ribonucleic acid is a nucleic acid present in all living cells and has structural similarities to DNA.
“In prostate cancer, certain genes become active,” Ramin said. “Those genes are transcribed into RNA strands. The RNA strands then code for certain proteins that are active in prostate cancer. liquid biopsy tests do not definitively diagnose prostate cancer. A positive test triggers the need to do an actual tissue biopsy of the prostate.”
The prostate-specific antigen test is not always an accurate screening test for prostate cancer, Ramin explained. Not all patients with elevated PSA levels need to undergo an invasive prostate biopsy to determine the presence of prostate cancer.
“In patients with elevated or abnormal PSA tests, we can do additional testing to determine if an actual tissue biopsy is required,” Ramin said. “One of the additional tests is a liquid biopsy. Another additional test is an MRI of the prostate.”
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