Biopsy is the surgical removal of tissue from an organ to determine the presence or extent of a disease, mostly cancerous and inflammatory conditions.
In an official press release on June 1, 2016, the U.S. Food and Drug Authority (FDA) sanctioned regulatory approval to the first ever blood-based assay, cobas EGFR mutation Test v2, for the drug Tarceva. EGFR, or epidermal growth factor receptor, occurs in two out of 10 cases of non-small cell lung cancer (NSCLC). DNA from the tumor cells, pass into vascular system and into the blood, enabling blood samples to be used for effective detection of any signs of mutation.
“Approvals of liquid biopsy tests, make it possible to deliver highly individualized health care for patients,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible.”
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Manufactured by Roche Molecular Systems in Pleasanton, California, cobas EGFR Mutation Test v2 biopsy device, specifically determines exon 19 deletion or exon 21 (L858R) substitution mutations. This helps in differentiating those cases, which would benefit from Tarceva. In case, any mutation is not registered only then would a tumor biopsy be necessary.
On June 6, 2016, came the reported success of Next-2 trial, a comprehensive liquid biopsy tool, during first set of clinical trials by Guardant Health and Samsung Medical Center. A batch of 200 patients, diagnosed with advanced stages of cancer, were included as subjects for the trial. The aim was to validate the use of NEXT-2 liquid biopsy “as the sole diagnostic tool” to assist oncologists in establishing the efficacy of therapeutic drugs for different types of cancer. The resultant outcome of the study, was fairly satisfying for the researchers in improving net efficiency of this biopsy technique. In addition, it helped generate substantial response rates for some types of cancer, 88% in lung cancer and 60% in gastric cancer.
A group of investigators from Johns Hopkins Kimmel Cancer Center and the University of Melbourne ventured to implement liquid biopsy for estimating recurrence rates of colon cancer. A small batch of early-stage colon cancer patients were studied during their research. They released their findings during early July, 2016 suggesting its success. They had innovated a basic test to assist clinical experts plan whether or not a patient diagnosed with early stages would require further therapies for stage II. This is essential with regard to the fact that that stage II tumors do influence, but not infect other organs in vicinity. Therefore, there exists no proof of benefit from chemotherapy post-surgery. The liquid biopsy test discussed in their study, proved its potential to define extreme-risk scenario. Later, it was easier to comprehend the degree of positive response generated in them, once supplementary treatments were given.
“When such a generic test is developed, it could still catch more than 90% of colorectal cancers, and it would eliminate the need to retrieve and test individual tumor samples, thus saving time, effort, and money,” added Peter Gibbs, M.D., a Ludwig investigator at WEHI who co-led the study.
“There is mounting evidence that ctDNA [circulating tumor DNA] is a viable approach for earlier detection of cancer recurrence, and more research is underway to refine the technology, improve its sensitivity and determine the best testing intervals,” concluded co-author Kenneth Kinzler, Ph.D., co-director of the Ludwig Center at the Johns Hopkins Kimmel Cancer Center.
Non-invasive, is the keyword, when it comes to the popularity of liquid biopsy techniques. A cancer-struck patient, too sick for painful surgical extraction of tumor cells, finds comparative relief in those small needle pricks. Besides that, the researchers have the benefit of a more complex genetic profile, rather than just the tumor cells.
The precision medicine segment finds exciting applications for minimal, or non-invasive technique of isolating tumor DNA from bio fluids for liquid biopsy. Previously, even with the recognition of prominent molecular signatures, building up patient cohorts with similar profile using biomarkers as the base, failed in practical scenarios. It was combination of targeted proteomics and computational biology that helped recognize significant signatures in prostate cancer. With advanced devices that have been trained through rigorous datasets it becomes easier to build predictive models. As far as the research in that segment goes, computer-assisted proteomics would eventually lead to the sighting of high-accuracy biomarkers in body fluids. The world biopsy market expects high projections of market shares to the account of liquid biopsy segment given the current investigative trends.
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