Top Liquid Biopsy Companies Developing MCED Test

Published: December 2023


Liquid biopsies have emerged as a versatile diagnostic solution, especially for cases when conventional (invasive) diagnostic tests are inconclusive or when the clinical condition is related to an organ that is not amenable to biopsy access. We analyzed over 170 liquid biopsy products, along with information on over 80 liquid biopsy companies. In this article, discover top 7 liquid biopsy companies that shine in the competitive landscape of multicancer early diagnosis (MCED) tests.


Cancer is known to be one of the leading causes of death worldwide. In 2023, 0.6 million deaths due to cancer are estimated in the US alone. Moreover, the World Health Organization has estimated the number of new cancer cases to rise by 70% over the next 20 years. One of the primary reasons for the high mortality associated with this condition is believed to be late diagnosis. This results in delayed treatment, which severely compromises chances of survival. For many years, tissue biopsy has been considered the gold standard for cancer diagnosis. However, owing to the invasive nature of the test, biopsies cannot be repeated frequently to assess / measure disease progression or monitor therapeutic outcome. In fact, in some cases, it is not possible to carry out a biopsy because the affected tissue / organ is not amenable to undergo such a painful and traumatic procedure. This has resulted in a significant unmet need for safer and more patient friendly cancer diagnostics that are capable of offering accurate test results. 

Advances in the field of biotechnology have enabled the establishment of several minimally invasive / non-invasive approaches for disease diagnosis. Liquid biopsy tests have emerged as a versatile and promising tool for non-invasive cancer diagnostic and as companion diagnostic. This procedure is based on the analysis of biofluids (such as blood, urine and / or plasma) in order to detect rare forms of biomarkers. Owing to the non-invasive nature of the test, it can be actively used to monitor / track changes in tumors, both before and during the course of treatment. Other than liquid biopsy, the cancer diagnostics market has witnessed the emergence of several other non-invasive diagnostic technologies, which are based on analytes that are either superficially located (such as skin lesions) and / or are expelled from the body (such as bronchial fluids and exhaled breath). In future, non-invasive cancer diagnosis methods, particularly liquid biopsies, are anticipated to replace the existing invasive diagnostic techniques. Roots Analysis has conducted an exhaustive study on Liquid Biopsy Market featuring the current market landscape and future opportunity for the liquid biopsy products and liquid biopsy companies, over a span of 12 years.

Table of Contents

The top 7 liquid biopsy companies manufacturing various liquid biopsy assay kits are listed below (in alphabetical order):

  1. Biocartis
  2. CellMax Life
  3. Datar Cancer Genetics
  4. Genostics
  5. Guardant Health
  6. INOVIQ
  7. Singlera Genomics

Top 7 Liquid Biopsy Companies Developing MCED Test

Interested in exploring all 80+ Liquid Biopsy Companies?

Discover Below the Details on Top 7 Liquid Biopsy Companies

This article highlights top 7 leading liquid biopsy companies to watch out for in 2023. The liquid biopsy companies presented in this article are currently manufacturing more than one liquid biopsy product for the purpose of early cancer diagnosis. It is essential to note that the selection of top liquid biopsy companies can differ substantially according to the defined criteria(s).

Biocartis, One of the Belgium-based Liquid Biopsy Companies, Focused on Manufacturing Assay Kits

Biocartis - Liquid Biopsy Companies

Biocartis is a commercial stage molecular diagnostics company. It offers various next generation diagnostic solutions, which are aimed at further improving clinical practice for the benefit of clinicians, patients and payers. The company has also developed a proprietary molecular diagnostic platform, Idylla. Idylla is a real time system, which is fully automated and offers very accurate information. In order to address the growing demand for personalized medicine, Idylla platform allows treatment selection and treatment monitoring. In addition, the company envisions to enable personalized medicine for patients across the globe through molecular testing.

List of Liquid Biopsy Products Manufactured

Product Name Type of Bioreactor Detected 
Idylla™ ctKRAS Mutation Test Circulating Tumor KRAS
Idylla™ ctNRAS-BRAF Mutation Test Circulating Tumor DNA (ctDNA)
Idylla™ ctBRAF Mutation Test Circulating Tumor DNA (ctDNA)
Idylla™ ctEGFR Mutation Assay Circulating Tumor DNA (ctDNA)

 

Recent Developments and Future Outlook

In February 2023, the company announced the launch of the Idylla IDH1-2 Mutation Assay Kit (RUO)1 for selected customers. The company stated that it is the first test developed using Idylla FLEX technology. This assay kit helps in separating the generic component of Idylla test from the test-specific components.

Previous year, in February, the company announced the launch of the company’s Idylla ctEGFR Mutation Assay. The company mentioned that this test is the liquid biopsy version of its solid biopsy test, Idylla EGFR Mutation Test. The company is anticipated to launch more such liquid biopsy products in the foreseen future to expand its existing portfolio.

Further detailed information related to the company’s liquid biopsy products, recent partnerships and funding initiatives is available in the full report.
 

CellMax Life, a US based Company, Specializing in Performing Clinical Trial to Evaluate its Liquid Biopsy Products

CellMax Life - Liquid Biopsy Companies

CellMax Life claims to be one of the leading cancer diagnostics companies with a mission to transform the currently available cancer diagnostic methods. The company aims to do it by generating affordable non-invasive tests for early cancer detection and management. In addition, company mentions that its unique expertise in circulating tumor cell and next generation sequencing of DNA and circulating tumor DNA (ctDNA) has resulted into multiple highly effective precision medicine solutions for both patients diagnosed with cancer and healthy people.

List of Liquid Biopsy Products Manufactured

Product Name Type of Bioreactor Detected 
CellMax-CRC Colorectal Cancer Early Detection Test Circulating Tumor DNA (ctDNA)
CellMax-Prostate Cancer Test Circulating Tumor DNA (ctDNA)
CellMax-LBx Liquid Biopsy Circulating Tumor DNA (ctDNA)
CellMax-PanCa Monitoring Test Circulating Tumor DNA (ctDNA)

 

Recent Developments and Future Outlook

In January 2023, CellMax Life shared the data from its multisite prospective study of its blood-based colorectal cancer detection assay. The company stated that the results were very positive regarding the sensitivity of assay for detecting advanced adenomas, dysplastic precursor nodules at a high risk of transforming into malignant colorectal cancer. Further detailed information related to the company’s liquid biopsy products, recent partnerships and funding initiatives is available in the full report.
 

Datar Cancer Genetics Leveraging its Fully Equipped Team Focus on the Manufacturing of Various Liquid Biopsy Product

Datar Cancer Genetics - Liquid Biopsy Companies

Datar Cancer Genetics claims to be a world-leading molecular oncology facility that is NABL, ISO, CAP and CLIA accredited. The facility is fully equipped with in-house bioinformatics team, integrated process platforms and big genetic data base for precise and updated reporting. The company claims that various national and international cancer research institutes across the globe avail themselves of their services. In addition, the company also mentions that using various latest technologies, it offers highly effective treatment solutions for the cancer patients that have undergone multiple failed treatments. One such technology includes the company’s liquid biopsy products. The company current liquid biopsy portfolio includes Cancertrac, Early Check 360, Trublood and Trucheck.

List of Liquid Biopsy Products Manufactured

Product Name Type of Bioreactor Detected 
Cancertrack Circulating Tumor DNA (ctDNA), Extracellular Vesicles
Early Check 360 Circulating Tumor DNA (ctDNA)
Trublood Circulating Tumor DNA (ctDNA)
Trucheck Circulating Tumor DNA (ctDNA)

 

Recent Developments and Future Outlook

In January 2023, the company announced that the USDFA granted breakthrough designation for its TriNetra-Glio blood test. This test is used for the diagnosis of brain tumor. This is the third test from company that has received the breakthrough device designation from the USFDA. Further, it is worth highlighting that the company's early-stage breast and prostate cancer detection tests have become the first liquid biopsies to receive the Breakthrough Device Designation. We anticipate that the company will invest more in the research and development sector to receive more such designations for its liquid biopsy products. Further detailed information related to the company’s liquid biopsy products, recent partnerships and funding initiatives is available in the full report.
 

Genostics is one of the Australia-based Liqiud Biopsy Companies Having Capability to Manufacture Assay Kits for the Detection of ctDNA

Genostics - Liquid Biopsy Companies

Genostics® is an Australia based small company that it focused on medical diagnostic, education and offer consultancy services. It partners with various world-class cancer research laboratories in Europe so as to bring the best in personalized cancer testing medical communities across the globe. The company mentions that it engages themselves with pioneering practitioners who seek to discover the nature of cancer. The company assists them by helping the practitioners to design personalized treatment plans and closely monitor the effectiveness of the resulting therapies.

List of Liquid Biopsy Products Manufactured

Product Name Type of Bioreactor Detected 
Maintrac® CTC Test Circulating Tumor DNA (ctDNA) 
Maintrac® Customised Chemosensitivity Testing  Circulating Tumor DNA (ctDNA)
Maintrac Tumour Sphere Units test Circulating Tumor DNA (ctDNA)

 

Recent Developments and Future Outlook

Genostics aim to reduce the impact of cancer by offering tests that enable personalized treatment and performs real time monitory of treatment. In addition, the company also aims to pioneer the utility of molecular technologies in clinical settings. Despite the fact that publicly available information for the company is fairly limited, we anticipate the company to enter in more collaboration to further enhance its liquid biopsy tests.
 

Guardant Health Recently Launched a Shield-based Screening Test to Perform Liquid Biopsy Tests

Guardant Health - Liquid Biopsy Companies

Guardant Health is a US based company that is focused on developing proprietary tests and advanced analytics for the detection of various types of cancers. The company mentions that it helps cancer patients to live longer and healthier lives using the power of blood tests. In addition, the company also states that its USFDA approved tests assists in taking informed decisions for the patients suffering from advanced stage of cancer. Further, these blood based tests offered by the company also helps in detecting residual and recurrent type of cancer. 

The company has various commercially launched platforms in its portfolio that can be used for the detection of cancer such as Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, GuardantINFINITY™ tests and Guardant Reveal™ for early-stage cancer patients.

List of Liquid Biopsy Products Manufactured

Product Name Type of Bioreactor Detected 
Guardant 360® Circulating Tumor DNA (ctDNA) 
Guardant Reveal™   Circulating Tumor DNA (ctDNA)
Shield™ Cell Free DNA  (cfDNA)

 

Recent Developments and Future Outlook

Recently, in November 2013, Guardant Health announced the launch of its Shield-based screening test in collaboration with Samsung Medical Center. The company mentioned that its screening test can be used for the detection of colorectal cancer. In addition, in January 2023, Guardant Health received the USFDA approval for Guardant360® CDx as a companion diagnostic for Menarini’s ORSERDU™. The company mentioned that Guardant360® CDx can be used for the detection of advanced / metastatic breast cancer patients with ESR1 mutations. Given the number of initiatives undertaken by the company in the recent past, we anticipate the company to invest more in the research and development sector in order to lead in the race of liquid biopsy. Further detailed information related to the company’s liquid biopsy products, recent partnerships and funding initiatives is available in the full report.
 

INOVIQ Entering into Licensing Agreements in Order to Expand the Access of its Proprietary Technology

INOVIQ - Liquid Biopsy Companies

INOVIQ is a large company focused on the development and commercialization of innovative diagnostic and exosome-based products. The company mentions that these products helps in early diagnosis, prognosis and monitoring of various types of cancers and other disorders. Further, company has commercialized EXO-NET pan-exosome capture tool that can be used for various research purposes and hTERT test that can be used as an adjunct to urine cytology testing for bladder cancer and. Along with the commercialized products, the company also has cancer diagnostic products that are under development. Examples of these include blood tests for early cancer diagnosis and monitoring of prostate, breast, ovarian and other cancers.

List of Liquid Biopsy Products Manufactured

Product Name Type of Bioreactor Detected 
BARD1-Lung BARD1 tumor markers 
BARD1-Ovarian   BARD1 tumor markers

 

Recent Developments and Future Outlook

Recently, in September 2023, the company announced a licensing and supply agreement with ResearchDx. Under the agreement, both the companies aim to deliver EXO-NET enabled high-throughput exosome isolation, biomarker discovery and diagnostics development services to the clientele in the US. In addition, ResearchDx mentioned that it will offer a wide range of contract research services to the US customers using INOVIQ’s EXO-NET exosome capture tool. Further detailed information related to the company’s liquid biopsy products, recent partnerships and funding initiatives is available in the full report.
 

SINGELERA Genomics, One of the US based Liquid Biopsy Companies, Having Received Breakthrough Designation for its Liquid Biopsy Test

Singlera Genomics - Liquid Biopsy Companies

Singlera Genomics is a small company that is focused on the development of various liquid biopsy reagents and software. The company’s liquid biopsy portfolio includes PDACatch Assay, PanSeer assay and ColonES Assay. The company’s PanSeer assay uses a sophisticated and targeted methylation assay, along with efficient bioinformatics analysis to detect cancer four years before the conventional diagnosis. Further, the company’s ColonES assay has high sensitivity and offers high specificity against advanced cancers. The company mentions that it welcomes any partnership opportunity to bring this revolutionary technology to market.

List of Liquid Biopsy Products Manufactured

Product Name Type of Bioreactor Detected 
PDACatch Assay Circulating Tumor DNA (ctDNA)
PanSeer assay   Circulating Tumor DNA (ctDNA)
ColonES Assay  Circulating Tumor DNA (ctDNA)

 

Recent Developments and Future Outlook

In May 2023, the USFDA granted breakthrough device designation to Singlera’s PDACatch liquid biopsy assay. The assay is a DNA methylation-based assay that is intended for the identification of pancreatic adenocarcinoma in patients that are at high risk of developing the disease. In addition, the assay is capable of identifying methylation patterns in circulating DNA in blood that originates from patients suffering from precancerous pancreatic lesions and early-stage pancreatic adenocarcinomas. Further detailed information related to the company’s liquid biopsy products, recent partnerships and funding initiatives is available in the full report.

What About the Other Liquid Biopsy Companies?

The above presentation features seven promising liquid biopsy companies selected from a pool of over 80 companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

About Author

Ankita_Kashyap

Ankita_Kashyap is a business research and competitive intelligence professional with over four years of experience in the pharmaceutical and healthcare industry. As an associate at Roots Analysis, she has authored numerous trending multidisciplinary market research reports, including viral vectors, aseptic manufacturing, continuous manufacturing, bioprinting, ADC technology, membrane filtration, liquid biopsy and more. She has continuously provided her valuable insights into the latest innovations in healthcare. During her professional journey, she has acquired good analytical skills in the pharmaceutical and biopharmaceutical industry, which in turn has contributed to the firm’s intellectual capital. This has allowed our clients to make informed decisions in the dynamic pharmaceutical landscape. She embarked upon her career with us. She started her journey as a business analyst with Roots Analyst and in such a short span of time, she has demonstrated amazing dedication. Till date, she has contributed to over 20 research reports.

Ankita holds a Master’s degree in Pharmacology from Chitkara University. While pursuing her education, she contributed her skills for various review and research literature. The impact of her learnings can be found   in her professional blogs, market research reports and social media profiles.

Source1: https://www.biocartis.com/sites/default/files/2023-10/230209_pr_idylla_flex_eng_final.pdf
Source2: https://www.abacusdx.com/molecular/biocartis-launches-liquid-biopsy-idylla-ctegfr-mutation-assay-ruo/
Source3: https://www.precisionmedicineonline.com/liquid-biopsy/colorectal-cancer-detection-data-cellmax-life-bodes-well-planned-fda-bid
Source4: https://www.prnewswire.com/news-releases/us-fda-grants-breakthrough-designation-for-blood-test-to-help-diagnose-inaccessible-brain-tumors-301711883.html?tc=eml_cleartime
Source5: https://www.prnewswire.com/in/news-releases/guardant-health-launches-shield-blood-based-screening-test-for-colorectal-cancer-in-south-korea-301984897.html
Source6: https://investors.guardanthealth.com/press-releases/press-releases/2023/Guardant-Health-receives-FDA-approval-for-Guardant360-CDx-as-companion-diagnostic-for-Menarini-Groups-ORSERDU-for-treatment-of-patients-with-ESR1-mutations-in-ER-HER2--advanced-or-me
Source7: https://www.inoviq.com/site/pdf/66ac6da1-413c-40b6-a9eb-54f41196080a/IIQ-and-ResearchDx-sign-USA-EXONET-Services-Agreement.pdf
Source8: https://www.medicaldevice-network.com/news/fda-breakthrough-singlera-liquid-biopsy-assay/?cf-view

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