“A simple blood test can rapidly and accurately detect mutations in two key genes in non-small cell lung tumors, researchers at Dana-Farber Cancer Institute and other institutions report in a new study – demonstrating the test’s potential as a clinical tool for identifying patients who can benefit from drugs targeting those mutations.
“The test, known as a liquid biopsy, proved so reliable in the study that the Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) this week became the first medical facility in the country to offer it to all patients with non-small cell lung cancer (NSCLC), either at the time of first diagnosis or of relapse following previous treatment.
“NSCLC is the most common form of lung cancer, diagnosed in more than 200,000 people in the United States each year, according to the American Cancer Society. An estimated 30 percent of NSCLC patients have mutations in either of the genes included in the study, and can often be treated with targeted therapies. The study is being published online today by the journal JAMA Oncology.”
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“Two new studies published on Wednesday of patients with breast and prostate cancers add to growing evidence that detecting bits of cancer DNA circulating in the blood can guide patient treatment.
“Enthusiasm is building for ‘liquid biopsies,’ which offer a non-invasive alternative to standard tissue biopsies and are expected to be a multibillion-dollar market.
“But a key question remains: Do they really work?
“The stakes are high. At least 38 companies are working on liquid biopsies for cancer, according to analysts at investment bank PiperJaffray, who think the U.S. market alone could eventually reach $29 billion a year.”
“The way we find cancer in our bodies today is often messy, imprecise and even potentially dangerous. It often involves taking sometimes fuzzy, unreadable images with CTs, MRIs and X-ray machines and cutting open our bodies to harvest bits of tissue for further analysis.
“Most of us never think to undergo such testing until it’s too late, and the cancer has already well on its way to killing us.
“A California-based company called Pathway Genomics is aiming to shake up this way of thinking about cancer detection. In September, Pathway announced that it would be offering an ‘early warning’ test that it says can detect snippets of abnormal DNA — for a whole group of major cancers, including breast, ovarian, lung, thyroid and prostate — in otherwise healthy people from a single vial of blood.”
“As the field of liquid biopsies for tracking disease progression and therapeutic response heats up, many doctors are looking for ways to apply this approach to their patients. Currently, assays for circulating tumor cells (CTCs) – one type of liquid biopsy – have been approved for diagnostic purposes in metastatic breast, colorectal, or prostate cancer. In these diseases, the presence of CTCs in the peripheral blood is associated with decreased progression-free survival and decreased overall survival. The major challenge for this technology is that CTCs are not always found in the blood of patients with aggressive disease who would be expected to have high numbers. Now, researchers at Thomas Jefferson University investigating uveal melanoma, a type of melanoma that originates in the eye, have shown that the low numbers could simply be explained by where the blood is drawn – whether from a vein or an artery.”
“Biodesix, Inc. today announced the launch of GeneStrat™, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer (NSCLC). The blood test results are available within 72 hours, providing physicians actionable diagnostic information prior to making treatment decisions. GeneStrat is focused exclusively on the clinically actionable EGFR, KRAS, and BRAF mutations often used to guide targeted therapy treatment decisions. GeneStrat also captures the EGFR T790M mutation, which can be used for monitoring the emergence of the primary resistance mutation in the EGFR gene. It is anticipated that two drugs targeting the resistance mutation may be available later this year. GeneStrat uses the ddPCR platform to analyze cell-free tumor DNA and is highly concordant with tissue analysis, currently considered the gold standard.
“Roughly 30% of lung cancer patients either have insufficient biopsy tissue or are not candidates for a biopsy for tumor mutation profiling. Even in cases where tissue biopsy is available, the sense of urgency to treat is great, with one recent study showing that one out of four patients begin cancer treatment before receiving mutation test results. Requiring only a blood draw, GeneStrat offers a fast, minimally invasive alternative to a high-risk tissue biopsy or re-biopsy in patients with insufficient tissue.
“In addition to providing a minimally-invasive source of mutation status, liquid biopsy can be more cost-effective than traditional tissue biopsies. The mean cost of each tissue biopsy is $14,634 across all patients. The cost of a tissue biopsy can be up to four time higher in the 19.3% of patients who have complications associated with the biopsy. GeneStrat liquid biopsy can help avoid the cost and complications of repeat tissue biopsy.”
“Biocept, Inc. (Nasdaq: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the diagnosis and treatment of cancer, continues to build evidence of the clinical utility of its liquid biopsy offerings with an abstract at the 2015 Annual American Society of Clinical Oncology Meeting in Chicago starting on May 29, 2015.
“Biocept offers a sensitive and quantitative blood-based method for the detection and monitoring of clinically actionable cancer biomarkers in order to help doctors make treatment decisions based on genomic information gained from the tumor material. The Company is engaged in multiple clinical studies designed to demonstrate the utility of its liquid biopsy diagnostic to detect a patient’s biomarker status and for the assessment of treatment response over time.
“The abstract demonstrates the clinical utility of a liquid biopsy using Biocept’s technology, not only for a patient where there is insufficient tissue from a biopsy, but also in order to better represent a patient’s biomarker status by avoiding challenges associated with tissue heterogeneity, all accomplished with a simple blood draw.”
“A new type of blood test is starting to transform cancer treatment, sparing some patients the surgical and needle biopsies long needed to guide their care.
“The tests, called liquid biopsies, capture cancer cells or DNA that tumors shed into the blood, instead of taking tissue from the tumor itself. A lot is still unknown about the value of these tests, but many doctors think they are a big advance that could make personalized medicine possible for far more people.
“They give the first noninvasive way to repeatedly sample a cancer so doctors can profile its genes, target drugs to mutations, tell quickly whether treatment is working, and adjust it as the cancer evolves.
“Two years ago, these tests were rarely used except in research. Now, several are sold, more than a dozen are in development, and some doctors are using them in routine care.”
“In the usual cancer biopsy, a surgeon cuts out a piece of the patient’s tumor, but researchers in labs across the country are now testing a potentially transformative innovation. They call it the liquid biopsy, and it is a blood test that has only recently become feasible with the latest exquisitely sensitive techniques. It is showing promise in finding tiny snippets of cancer DNA in a patient’s blood.
“The hope is that a simple blood draw — far less onerous for patients than a traditional biopsy or a CT scan — will enable oncologists to quickly figure out whether a treatment is working and, if it is, to continue monitoring the treatment in case the cancer develops resistance. Failing treatments could be abandoned quickly, sparing patients grueling side effects and allowing doctors to try alternatives.
“ ‘This could change forever the way we follow up not only response to treatments but also the emergence of resistance, and down the line could even be used for really early diagnosis,’ said Dr. José Baselga, physician in chief and chief medical officer at Memorial Sloan Kettering Cancer Center.
“Researchers caution that more evaluations of the test’s accuracy and reliability are needed. So far, there have been only small studies in particular cancers, including lung, colon and blood cancer. But early results are encouraging. A National Cancer Institute study published this month in The Lancet Oncology, involving 126 patients with the most common form of lymphoma, found the test predicted recurrences more than three months before they were noticeable on CT scans. The liquid biopsies also identified patients unlikely to respond to therapy.”
The gist: A new blood test might help people with non-small cell lung cancer (NSCLC) make decisions about their treatment. Doctors often use molecular testing to look for tumor mutations that might affect which treatments they suggest to a patient. Molecular testing requires tumor cells, which are usually taken directly from the tumor in a biopsy. A new, less invasive molecular test for NSCLC just requires a blood sample. The test uses circulating tumor DNA, pieces of DNA released by tumor cells into the bloodstream. It looks for a mutation known as ROS1 gene rearrangement. Patients with this mutation might be able to take specific drugs that target the mutation to treat cancer.
“Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and Circulating Tumor Cells (CTCs), today announced the launch of ROS1 testing on CTCs, which will help physicians identify which of their patients may be receptive to certain drugs for the treatment of non-small cell lung cancer.
“Biocept’s new blood test identifies chromosomal rearrangements of the gene encoding ROS1 proto-oncogene receptor tyrosine kinase (ROS1), thereby defining a distinct molecular subgroup of NSCLCs. Patients with ROS1-positive tumors may be receptive to a number of therapeutic options that inhibit this target.
“It can be difficult to obtain enough tissue material for molecular testing of biomarkers like ROS1 from lung cancer patients due to the small size of tissue biopsies. Occasionally, tissue biopsies are altogether impossible because of risks associated with a surgical procedure for these patients. Biocept’s ‘liquid biopsy’ offers a method of determining the crucial genomic status of a tumor using a simple blood test.”