Upcoming Cell-free DNA Technology to Revolutionize Genetic Testing

Cell-free DNA are small fragments of DNA circulating freely in the blood and body fluids, first identified in 1948, which are utilized as a valuable biomarker to advance personalized medicine, and improve the quality of life. With advancement in various sequencing technologies and bioinformatics algorithm analysis of the cell-free DNA to detect various medical conditions such as chromosomal abnormalities, cancer and transplantation rejections have been made affordable for early disease diagnosis. It is relatively a new technology in which small amount of liquid sample (blood, urine, saliva and others) from the patient is collected to analyze the freely circulating DNA.. This is a non-invasive technique and has the potential to revolutionize the genetic testing worldwide. According to IQ4I Research and Consultancy, the global cell-free DNA testing market is expected to grow at a double digit CAGR from 2015 to reach $8,988 million by 2022.

Increased incidences of disease like cancer and fetal chromosomal abnormalities due to increase of average maternal age in high income countries and change in lifestyle due to changing pattern of education, employment, marriages and unhealthy diet habits. In addition, raising healthcare awareness, increasing healthcare expenditure and non-invasive test nature are likely to propel the cell-free DNA testing market. On the other side, there are some issues like high test cost, lack of skilled healthcare professional and ethical issues related to genetic testing are factors hindering the growth of the market.

Cell-free DNA testing market includes non-invasive prenatal testing (NIPT), circulating tumor DNA (ctDNA) and donor-derived cell-free DNA testing. Prenatal testing is a method to identify any chromosomal abnormality in the fetus by collecting the blood sample of the pregnant women which contains DNA of the fetus. This method is safe and causes no harm to the developing fetus like other invasive procedures. ctDNA testing is another technique in which circulating tumor DNA in blood, urine or saliva of the cancer patients are analyzed to detect specific mutation. This will help in accurate diagnosis, formulating the treatment and monitoring of the patient post treatment. This method is less painful and is less invasive than a standard tissue biopsy procedure. Finally, donor-derived cell-free DNA testing analyzes the graft rejection in transplanted patient by identifying the presence or absence of the donor DNA in the person’s bloodstream. In case of tissue damage of the transplanted organ there will be the presence of donor cell-free DNA in the blood because of the necrosis of the cells. Prenatal testing and ctDNA testing are the dominant segments currently in the cell-free DNA testing market whereas donor-derived cell-free DNA testing is also catching up with many companies and are planning to launch new tests in the market.

NIPT segment held the largest market revenue and expected to reach $3,131 million by 2022 with a healthy CAGR. Cell-free DNA testing has application in the fields like gynecology, oncology and transplantation to detect chromosomal abnormalities in the fetus, specific mutations in cancer patients and to detect graft rejection.

Major players in the market are launching new tests, acquiring start-up companies, small players or funding research to maintain market leadership. For instance, in June 2016, Roche Holdings AG received U.S. FDA approval for its newly launched ctDNA test named cobas EGFR mutation test V2, FDA-approved first blood based genetic test that detect EGFR gene mutation in NSCLC patients. Roche also entered the NIPT market with the acquisition of Ariosa Diagnostics for $650 million in January 2015. In January 2016, Illumina announced the formation of a new company GRAIL with a funding of over $100 million. CareDx, Inc., acquired Allenex AB in April 2016 for the developments of its new donor derived cell-free DNA tests for kidney and heart transplant patients. TAI diagnostics raised $8.2 million in October 2015 to commercialize blood test for heart transplant patients. Numerous companies are coming up with new technologies and processes. For instance, Illumina, Inc. is one of the leading companies that have filed nearly 47 PCT applications in last five years for covering different aspects of cfDNA testing.

The cell-free DNA market is extremely competitive. Many companies are coming up with new softwares and with the improvement in sequencing technology to improve test quality which will give rapid and accurate results. For example, Onesight is new software introduced by Agilent technology, a U.S. based company, to analyze chromosomal aneuploidies in cell-free DNA sequencing data and applying that to wide application range, from early cancer detection to fetal abnormalities screening.

North American region commanded the largest revenue due to majority of tests launched in this region, increasing incidence of genetic disease, adaptation of advanced technology in the screening procedure, advanced healthcare infrastructure. Asia Pacific region is the fastest growing due to changing lifestyle, booming economy and improving healthcare infrastructure among the countries in this region.

The prominent players operating in the cell-free DNA testing market are Berry Genomics Co. Ltd (China), BGI (China), Biocept, Inc. (U.S), Guardant Health, Inc. (U.S), Illumina, Inc. (U.S.), Inivated Limited (U.K.), Laboratory Corp. of America Holdings (U.S.), LifeCodexx AG (Germany), Natera, Inc. (U.S), Quest Diagnostics (U.S.), Roche Holdings AG (Switzerland), Sequenom, Inc. (U.S), Trovagene, Inc. (U.S).

Some of the other players operating in cell-free DNA testing market are Chronix Biomedical (U.S.), Foundation medicine (U.S.), CareDx, Inc. (U.S.), Cynveinio Biosystems, Inc. (U.S.), GATC biotech (Europe), Biocartis (Belgium), Biodesix, Inc. (U.S.), Circulogene Theranostics (U.S.), Counsyl, Inc. (U.S.), Exact Sciences (U.S.), Molecular MD (U.S.), Multiplicom NV (Belgium), Neogenomics Laboratories (U.S.), Pathway Genomics (U.S.), Premaitha Health plc (U.K.), Prenatalis (Germany), Sysmex Inostics (Germany), TAI Diagnostics, Inc. (U.S.), Transgenomic, Inc. (U.S.).


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