Oct 15, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Silicon Valley startup is using gene sequencing to identify in the bloodstream free-floating genetic material shed by tumors
There has been plenty of excitement about the new diagnostic technologies designed to identify circulating tumor cells in blood samples. Now, a well-funded Silicon Valley startup has developed a blood test that it says holds promise for detecting early-stage lung and other cancers.
Though experimental, the screening test—which uses gene sequencing to identify in the bloodstream cancer-signaling genetic material shed by tumors—would be a boon for clinical laboratories and health networks. It also could play a role in advancing precision medicine treatments and drug therapies.
GRAIL, a Menlo Park, Calif., life sciences company, presented its initial findings at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago. Its lung cancer data is part of GRAIL’s ongoing Circulating Cell-Free Genome Atlas (CCGA) study, which aims to enroll 15,000 participants and investigate 20 different types of cancers.
“We’re excited that the initial results for the CCGA study show it is possible to detect early-state lung cancer from blood samples using genome sequencing,” said lead study author Geoffrey Oxnard, MD, Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School, in a Dana-Farber news release.
“There is an unmet need globally for early-detection tests for lung cancer that can be easily implemented by healthcare systems,” lead study author Geoffrey Oxnard, MD (above), said in the Dana-Farber news release. “These are promising early results and the next steps are to further optimize the assays and validate the results in a larger group of people.” (Photo copyright: Dana-Farber Cancer Institute.)
According to the news release, researchers in this initial analysis explored the ability of three different prototype sequencing assays, each with 98% specificity, to detect lung cancer in blood samples:
“The initial results showed that all three assays could detect lung cancer with a low rate of false positives (in which a test indicates a person has cancer when there is no cancer),” the Dana-Farber news release noted.
Identifying Disease Risk Before Symptoms Appear
Screening tests help identify individuals who are not displaying disease symptoms but may be at high risk for developing a disease. GRAIL’s goal is to develop a test with a specificity of 99% or higher. This means no more than one out of 100 people would receive a false-positive.
Otis Brawley, MD, Chief Medical and Scientific Officer at the American Cancer Society, points out that specificity is important when developing a population-based screening test that ultimately would be given to large portions of the general public based on age, medical history, or other factors.
“I am much more concerned about specificity than sensitivity [true positive rate], and [GRAIL] exhibited extremely high specificity,” Brawley told Forbes. “You don’t want a lot of false alarms.”
Some cancer experts have a wait-and-see reaction to GRAIL’s initial results, due in part to the small sample size included in the sub-study. Benjamin Davies, MD, Associate Professor of Urology at the University of Pittsburgh School of Medicine, and an expert on prostate cancer screening, told Forbes the early data was “compelling,” but the number of patients in the study was too small to generate excitement.
Oxnard, however, believes the initial results validate the promise of GRAIL’s blood screening test project.
“I was a skeptic two years ago,” Oxnard, a GRAIL consultant, told Forbes. “I think these data need to put a lot of the skepticism to rest. It can be done. This is proof you can find cancer in the blood, you can find advanced cancer, therefore this has legs. This has a real future. It’s going to be many steps down the line, but this deserves further investigation and should move forward.”
Next Steps
Researchers next plan to verify the initial results in an independent group of 1,000 CCGA participants as part of the same sub-study. They then will attempt to optimize the assays before validating them in a larger data set from CCGA, the Dana-Farber news release explained.
Illumina, a sequencing-technology developer, formed GRAIL in 2016, with participating investments from Bill Gates, Bezos Expeditions and Sutter Hill Ventures. Since then, GRAIL has attracted other high-flying investors, including Amazon, Merck, Johnson and Johnson, and Bristol-Myers Squibb.
Forbes notes that as of 2018 GRAIL has raised $1.6 billion in venture capital and has a $3.2 billion valuation, according to private market data firm Pitchbook. Last year, GRAIL merged with Hong Kong-based Cirina Ltd., a privately held company also focused on the early detection of cancer.
While GRAIL’s projects hold promise, anatomic pathologists and clinical laboratories may be wise to temper their enthusiasm until more research is done.
“We all would like to dream that someday you’d be able to diagnose cancer with a blood test,” Eric Topol, MD, Executive Vice President and Professor of Molecular Medicine at Scripps Research, told Forbes. Topol says he’s “encouraged” by GRAIL’s methodical approach, but warns: “We’re at the earliest stage of that.”
—Andrea Downing Peck
Related Information:
Biotech Firm GRAIL Takes the First Steps in Its Quest for a Blood Test for Cancer
Blood Test Shows Potential for Early Detection of Lung Cancer
Detection via Blood-Based Screening
Illumina Launches GRAIL, Focused on Blood-Based Cancer Screening
GRAIL and Cirina Combine to Create Global Company Focused on Early Detection of Cancer
Apr 11, 2018 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Some experts in medical community question value of health screenings of older patients with shortened life expectancies, though many aging adults are skeptical of calls to skip tests
What does it mean when a credible health organization makes the assertion that there is an “epidemic” of clinical laboratory testing being ordered on the nation’s elderly? Clinical laboratory leaders and anatomic pathologists know that lab tests are a critical part of screening patients.
Health screenings, particularly those for chronic diseases, such as cancer, can save lives by detecting diseases in their early stages. However, as consumers become more engaged with the quality of their care, one trend is for healthcare policymakers to point out that many medical procedures and care protocols may not bring benefit—and may, instead, bring harm.
No less an authority than Kaiser Health News (KHN) also is questioning what it calls an “epidemic” of testing in geriatric patients. Since medical laboratory tests are part of many screening programs, a rethinking of what tests are necessary in older patients would likely impact clinical laboratories and pathology groups going forward.
Treatment Overkill or Necessary Clinical Laboratory Tests?
“In patients well into their 80s, with other chronic conditions, it’s highly unlikely that they will receive any benefit from screening, and [it is] more likely that the harms will outweigh the benefits,” Cary Gross, MD, Professor of Medicine and Director of the National Clinician Scholars Program at the Yale School of Medicine, told KHN as part of an investigative series called “Treatment Overkill.”
That opinion is supported by a 2014 study published in the Journal of the American Medical Association (JAMA) Internal Medicine. The researchers concluded, “A substantial proportion of the US population with limited life expectancy received prostate, breast, cervical, and colorectal cancer screening that is unlikely to provide net benefit. These results raise concerns about over screening in these individuals, which not only increases healthcare expenditure but can lead to patient harm.”
Yet, seniors and their family members often request health screenings for themselves or their elderly parents, even those with dementia, if they perceive doing so will improve their quality of life, KHN noted.
Cary Gross, MD, Professor of Medicine and Director of the National Clinician Scholars Program at Yale University, told Kaiser Health News patients “well into their 80s, with other health conditions” are unlikely candidates for the many routine health screening tests administered to elderly patients. Were this to become a trend, medical laboratories could see a drop in physician-ordered screening tests. (Photo copyright: Yale University.)
Meanwhile, an earlier study in JAMA Internal Medicine found older adults perceived screening tests as “morally obligatory” and were skeptical of stopping routine screenings.
In its series, KHN noted two studies that outlined the frequency of screening tests in seniors with limited life expectancies due to dementia or other diseases:
- According to the American Journal of Public Health, nearly one in five women with severe cognitive impairment are still getting regular mammograms;
- Likewise, 55% of older men with a high risk of death over the next decade still receive PSA tests for prostate cancer, the 2014 JAMA Internal Medicine study found.
“Screening tests are often done in elderly patients as a knee-jerk reaction,” Damon Raskin, MD, a board-certified internist in Pacific Palisades, Calif., who also serves as Medical Director for two skilled nursing facilities, told AgingCare.com.
Correct Age or Correct Test?
While a movement may be afoot to reduce screening tests in older patients, a one-size-fits-all answer to who should continue to be tested may not be possible.
“You can have an 80-year-old who’s really like a 60-year-old in terms of [his or her] health,” Raskin noted. “In these instances, screening tests such as mammograms and colonoscopies, can be extremely valuable. However, I’ve seen 55-year-olds who have end-stage Parkinson’s or Alzheimer’s disease. For those individuals, I probably wouldn’t recommend screenings, for quality of life reasons.”
However, for the general population, researchers have emphasized that the focus should not be on whether physicians are ordering “unnecessary” lab tests, but whether they are ordering the “correct” tests.
A 2013 study published in the online journal PLOS ONE analyzed 1.6 million results from 46 of medicine’s 50 most commonly ordered lab tests. Researchers found, on average, the number of unnecessary tests ordered (30%) was offset by an equal number of necessary tests that went unordered.
“It’s not ordering more tests or fewer tests that we should be aiming for. It’s ordering the right tests, however few or many that is,” senior author Ramy Arnaout, MD, Harvard Medical School, Assistant Professor of Pathology and Associate Director of the Clinical Microbiology Laboratories at Beth Israel Deaconess Medical Center in Boston, stated in a news release. “Remember, lab tests are inexpensive. Ordering one more test or one less test isn’t going to ‘bend the curve,’ even if we do it across the board. It’s everything that happens next—the downstream visits, the surgeries, the hospital stays—that matters to patients and to the economy and should matter to us.”
Since the elderly are the fastest growing population in America, and since diagnosing and treating chronic diseases is a multi-billion-dollar industry, it seems unlikely that such a trend to move away from medical laboratory health screenings for the very old will gain much traction. Still, with increasing focus on healthcare costs, the federal government may pressure doctors to do just that.
—Andrea Downing Peck
Related Information:
Cancer Screening Rates in Individuals with Different Life Expectancies
Doing More Harm Than Good? Epidemic of Screening Burdens Nation’s Older Patients
Large-Scale Analysis Describes Inappropriate Lab Testing Throughout Medicine
Preventive Screening for Seniors: Is that Test Really Necessary?
Impact of Cognitive Impairment on Screening Mammography Use in Older US Women
Cancer Screening Rates in Individuals with Different Life Expectancies
The Landscape of Inappropriate Laboratory Testing
Older Adults and Forgoing Cancer Screening: ‘Think it would be Strange’
Nov 18, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
If this medical imaging collaborative develops a way to use the unstructured data in radiology images and anatomic pathology reports, it could create a new revenue stream for pathologists
Unstructured data has been regularly recognized as one Achilles heel for the anatomic pathology profession. It means invaluable information about the cancers and other diseases diagnosed by surgical pathologists are “locked up,” making it difficult for this information to be accessed in efforts to advance population health management (PHM) or conduct clinical studies.
Similarly, medical imaging has an essential role in the diagnosis of cancer and other diseases. And, like most anatomic pathology reports, medical imaging also is considered to be “unstructured” by data experts because it is not easily accessible by computers, reported Fortune magazine.
Unstructured Data in Anatomic Pathology and Radiology
Now one of the world’s largest information technology companies wants to tackle the challenge of unstructured data in radiology images. IBM (NYSE: IBM) Watson Health launched a global initiative involving 16 health systems, radiology providers, and imaging technology companies.
The Watson Health medical imaging collaborative is working to apply cognitive computing of radiology images to clinical practice. IBM aims to transform how physicians use radiology images to diagnose and monitor patients. (more…)
Jun 20, 2016 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
IBM’s Watson continues to seek a role as a cognitive computing tool of choice for physicians and pathologists in need of evidence-based clinical patient data
Remember IBM’s Watson? It’s been five years since Watson beat human contestants on Jeopardy. Since then, IBM has hoped Watson could be used in healthcare. To that end, some oncologists are exploring the use of Watson in cancer care. This could have implications for anatomic pathologists if oncologists developed a way to use Watson in the diagnosing cancers and identifying appropriate therapies for those cancers.
In 2011, IBM’s Watson supercomputer defeated human contestants for a charity prize during the television show Jeopardy. Just days later, Dark Daily reported on IBM’s goal for Watson to play a major role in helping physicians diagnose and treat disease. Since then, IBM has been exploring ways to commercialize Watson’s cognitive computing platform through partnerships with some of the healthcare industry’s biggest brands. (more…)
Aug 29, 2012 | Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Pathologists take heed! Teenagers are taking off-the-self technology and creating useful new clinical laboratory tests for cancer and other diseases
For the second time in recent weeks, a teenager has made national news for developing a medical laboratory test that can more accurately diagnose disease when compared to methodologies currently used by clinical laboratories and pathology groups. Pathologists and clinical chemists have good reason to ask what is different about the science taught in today’s high school compared to recent years.
The subject of our coverage today is a 17-year-old girl from Sarasota, Florida. She developed a computer application that detects breast cancer with 99% accuracy! It was on July 6 when Dark Daily e-briefing, told you about the 15-year old from Maryland who developed a diagnostic test to detect early-stage pancreatic cancer. (See “High School Student Develops Diagnostic Test to Detect Early-Stage Pancreatic Cancer”.) (more…)
