“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.”
“Biopsy guided by a fusion of magnetic resonance imaging (MRI) and ultrasound (US) improves detection of aggressive prostate cancer compared with mapping or targeting alone and systematic 12-core biopsy.
“Among the first 1,000 men to undergo MRI-fusion biopsy of the prostate at the University of California Los Angeles (UCLA), the presence of a grade 5 region of interest on fusion biopsy was the strongest predictor of high-grade prostate cancer. ‘Patients who had a grade 5 lesion compared to those who had no suspicious lesions had 23 times the odds of having Gleason ≥7 cancer,’ said Christopher Filson, MD, at UCLA.
“In a separate series of men presenting for prostate biopsy at New York University (NYU), MRI-targeted biopsy increased the detection of Gleason ≥7 prostate cancer by 23% compared with systematic biopsy while decreasing the detection of Gleason 6 disease by 26%.
“When a suspicious lesion shows up in the lungs on a CT scan, the first thing your doctor wants to know is whether it’s cancerous. A specialist will pass a long, thin bronchoscope into your airway in the hope of grabbing a few cells of the growth so they can be examined under a microscope.
“But some of these lesions or nodules are deep in the small branches of the lungs, out of reach of the bronchoscope, which is about the diameter of a pen. Other times, the results are inconclusive. That has left only two ways to determine whether the abnormality is cancerous: inserting a needle through the chest wall and into the tumor, or surgically opening a patient’s chest to find it (and remove it if necessary).
“The first procedure carries a 15 percent risk of collapsing a lung (pneumothorax), as well as infection. The second is serious surgery that requires general anesthesia and results in the loss of lung tissue. Both are in-patient procedures that carry the cost and other risks of hospitalizations. In about a third of the surgeries, the growth turns out to be benign, meaning the surgery was unnecessary.
“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.”
“Among a group of men with an initial negative prostate biopsy, clinically significant cancer is still found in subsequent repeat sampling rounds, according to a study published in the April issue of The Journal of Urology.
“Nitya E. Abraham, M.D., from the New York University School of Medicine in New York City, and colleagues collected data on 1,837 men who underwent prostate biopsy (Jan. 1, 1995, to Jan. 1, 2010). The authors sought to determine characteristics of repeat biopsy (indication for biopsy, the number of repeat biopsies performed, the number of cores obtained, and total prostate-specific antigen before biopsy), as well as features of prostate cancer diagnosed on repeat biopsy (including Gleason score, number of positive cores, percent of tumor and treatment choice).
“The researchers found that 1,213 men had negative initial biopsies, but that 798 repeat biopsies were performed in 255 men. Gleason score was ≤6 in 33 of 63 men diagnosed with prostate cancer, 7 in 22, and 8 to 9 in eight. Using Epstein criteria, the rate of clinically insignificant cancer diagnosis decreased substantially by the third and fourth repeat biopsies. An increased likelihood of prostate cancer diagnosis was seen in men ≥70 years with repeat biopsies, biopsies including more than 20 cores, and the fourth repeat biopsy.”
“Initial results from the Göteborg randomised screening trial indicates that using MRI (Magnetic Resonance Imaging) alongside conventional prostate cancer screening seems to offer improved cancer detection and can help avoid unnecessary biopsies.
“Prostate cancer is the third most common male cancer in Europe, accounting for over 92,000 deaths in 2012 (9% of male deaths). Screening for prostate cancer is a controversial issue, with until recently, little clear evidence that existing screening procedures, using PSA (to be followed by biopsies), were effective. In general, either the screening has tended to miss many cancers, or to give false positives, meaning that many men are subject to invasive testing and perhaps treatment which was just not necessary.
“The Göteborg Trial is the Swedish arm of the European Randomized Study of Screening for Prostate Cancer (ERSPC), which is the largest randomized prostate cancer screening trial in the world. In 2014 results from this trial showed a significant mortality reduction with prostate-specific antigen (PSA) screening for men aged 55-69 years of age. Now new work, presented at the European Association of Urology Conference in Madrid, shows that using MRI may further improve the accuracy of prostate cancer screening. This research has been awarded the EAU’s First Prize for the Best Abstract by a Resident.”
“Breast biopsies are good at telling the difference between healthy tissue and cancer, but less reliable for identifying more subtle abnormalities, a new study finds.
“Because of the uncertainty, women whose results fall into the gray zone between normal and malignant — with diagnoses like ‘atypia’ or ‘ductal carcinoma in situ’ — should seek second opinions on their biopsies, researchers say. Misinterpretation can lead women to have surgery and other treatments they do not need, or to miss out on treatments they do need.
“The new findings, reported Tuesday in JAMA, challenge the common belief that a biopsy is the gold standard and will resolve any questions that might arise from an unclear mammogram or ultrasound.”