Biodesix Launches GeneStrat Targeted Liquid Biopsy Mutation Test For Patients With Advanced Lung Cancer

“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.”


New Test Could Sharply Reduce Risky, Costly Lung Cancer Biopsies

“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.

“But now, according to a study published Sunday in the New England Journal of Medicine, there appears to be a new, much less invasive way of determining whether a growth is malignant.”


70-Gene Signature Not Cost-Effective in Breast Cancer

The gist: Doctors sometimes use molecular tests to help make treatment decisions. These tests give information about the genetics of a patient’s tumor. Different companies make different kinds of molecular tests for patients with node-negative breast cancer (NNBC). These tests help with decision-making for adjuvant chemotherapy—chemotherapy after tumor-removal surgery to keep the cancer from returning. Recently, scientists found that one of these tests was not cost-effective when compared to other options.

“For patients with node-negative breast cancer (NNBC), the 70-gene signature is unlikely to be cost-effective for guiding adjuvant chemotherapy decision making, according to a study published online Oct. 6 in the Journal of Clinical Oncology.

“Julia Bonastre, Ph.D., from Gustave Roussy in Villejuif, France, and colleagues conducted an economic analysis of the 70-gene signature used to guide adjuvant chemotherapy decision making in patients with NNBC. The 70-gene signature was compared with Adjuvant! Online and chemotherapy in all patients as a basis for the decision to administer adjuvant chemotherapy. Costs, life-years (LYs), and quality-adjusted life-years (QALYs) were compared over a 10-year period.

“The researchers observed similar mean differences in LYs and QALYs for the three strategies. Higher cost was seen in association with the 70-gene strategy, with a mean difference of €2,037 and €657 compared with Adjuvant! Online and systematic chemotherapy, respectively. The probability of being the most cost-effective strategy was 92 percent for Adjuvant! Online, 6 percent for systematic chemotherapy, and 2 percent for the 70-gene signature, for a €50,000 per QALY willingness-to-pay threshold.

” ‘Optimizing adjuvant chemotherapy decision making based on the 70-gene signature is unlikely to be cost-effective in patients with NNBC,’ the authors write.


Lung Cancer Screening Found Cost-Effective for Medicare

“Low-dose computed tomography (LDCT) is a low-cost and cost-effective strategy for screening Medicare beneficiaries for lung cancer, according to a study published in the August issue of American Health & Drug Benefits.

“Bruce S. Pyenson, from Milliman Inc. in New York City, and colleagues estimated the cost and cost-effectiveness (cost per life-year saved) of LDCT lung cancer screening in the Medicare population at high risk for lung cancer. Medicare & Medicaid Services (CMS) beneficiary files (2012) were used to establish Medicare costs, enrollment, and demographics. CMS and U.S. Census Bureau projections were used for forecasts to 2014.

“The researchers found that approximately 4.9 million high-risk Medicare beneficiaries would meet criteria for lung cancer screening in 2014. Without screening, Medicare patients newly diagnosed with lung cancer have an average life expectancy of approximately three years. The average annual cost of LDCT lung cancer screening is estimated to be $241 per Medicare person screened. For Medicare beneficiaries aged 55 to 80 years with a history of ≥30 pack-years of smoking and who had smoked within 15 years, assuming a 50 percent screening rate, LDCT screening for lung cancer is low cost, at approximately $1 per member per month. This screening demonstrates highly cost-effectiveness, at <$19,000 per life-year saved.

” ‘If all eligible Medicare beneficiaries had been screened and treated consistently from age 55 years, approximately 358,134 additional individuals with current or past lung cancer would be alive in 2014,’ the authors write. ‘LDCT screening is a low-cost and cost-effective strategy that fits well within the standard Medicare benefit, including its claims payment and quality monitoring.’ “


Single-Fraction RT as Effective as Multiple-Fraction RT for Palliation of Bone Metastases

The gist: Cancer patients with metastases in the bone may be treated with radiation to reduce pain. Many of these patients receive a radiation treatment known as multiple-fraction radiation therapy (MFRT). Research has shown that a different radiation treatment called single-fraction radiation therapy (SFRT) is just as effective as MFRT. But, internationally, MFRT is used much more often than SFRT. A new study says that a push to use SFRT more often “could lead to cost savings and improvement in patients’ quality of life.”

“Standardizing prescribing practices for single-fraction radiation therapy (SFRT) for palliation of bone metastases could lead to cost savings and improvement in patients’ quality of life, according to a study published in the August 1, 2014 edition of the International Journal of Radiation Oncology • Biology • Physics (Red Journal), the official scientific journal of the American Society for Radiation Oncology (ASTRO).”Bone metastases are a common manifestation of distant spread of disease, occurring most frequently with prostate, breast and lung cancers. Of these patients, two-thirds develop bone metastases to the spine, pelvis or extremities. Radiation therapy is an effective form of palliative treatment for bone metastases. There are more than 25 randomized controlled trials demonstrating that SFRT provides the same amount of pain control as multiple-fraction radiation therapy (MFRT); however, there is low use internationally of SFRT for bone metastases.

” ‘Use of Single- versus Multiple-Fraction Palliative Radiation Therapy for Bone Metastases: Population-Based Analysis of 16,898 Courses in a Canadian Province,’ is one of the largest, current studies on the use of SFRT. The study was designed to determine the use of SFRT in British Columbia, a publicly funded health care system where there is no financial incentive for extended fractionation and all radiation therapy is provided by the BC Cancer Agency with no direct cost to patients.”


What Cancer Costs You Later: $4,000 a Year

“Having cancer is bad enough. And the lifetime consequences have been well-documented — a higher risk of other cancers, heart disease and general weakness from the treatment.

“Now a new federal study shows there’s a financial burden too — on average, $4,000 a year for men and $3,000 for women over and above what people who haven’t had cancer spend.

“And that’s just direct medical costs. Cancer survivors also have thousands in lost productivity, from having to cut work hours or even quit their jobs, the report finds.”


What Cancer Costs You Later: $4,000 a Year

“Having cancer is bad enough. And the lifetime consequences have been well-documented — a higher risk of other cancers, heart disease and general weakness from the treatment.

“Now a new federal study shows there’s a financial burden too — on average, $4,000 a year for men and $3,000 for women over and above what people who haven’t had cancer spend.

“And that’s just direct medical costs. Cancer survivors also have thousands in lost productivity, from having to cut work hours or even quit their jobs, the report finds.”


What Cancer Costs You Later: $4,000 a Year

“Having cancer is bad enough. And the lifetime consequences have been well-documented — a higher risk of other cancers, heart disease and general weakness from the treatment.

“Now a new federal study shows there’s a financial burden too — on average, $4,000 a year for men and $3,000 for women over and above what people who haven’t had cancer spend.

“And that’s just direct medical costs. Cancer survivors also have thousands in lost productivity, from having to cut work hours or even quit their jobs, the report finds.”


Lung Cancer Screening Would Cost Medicare Billions

“Implementation of a national lung cancer screening program using low-dose computed tomography (LDCT) will identify almost 55,000 additional lung cancer cases over 5 years, but will add more than $9 billion to Medicare expenditures, according to results of a new study.

“Joshua A. Roth, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, discussed the economic analysis during a press conference in advance of the American Society of Clinical Oncology (ASCO) Annual Meeting, where results will be formally presented at the end of the month. He noted that following the positive results of the National Lung Screening Trial, the US Preventive Services Task Force recently recommended LDCT screening in healthy persons between the ages of 55 and 80 with at least 30 pack-years of smoking history. Medicare, meanwhile, is expected to release a draft decision on screening coverage in November of this year. ‘That decision will likely heavily weight the Task Force’s recommendation,’ Roth said.”