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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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For Early-State Lung Cancer Detection, GRAIL’s Experimental Clinical Laboratory Blood Screening Test Shows Promise

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

Consumers Increasingly Purchase Medical Laboratory Self-Test Kits for Blood Glucose, Cholesterol, and Colon Cancer Screening, according to Consumer Reports

The self-monitoring/self-test market is expected to swell to $19 billion by 2019, offering opportunities for pathologists and clinical laboratories to advise patients and ensure the proper use of home tests

Might the future of clinical laboratory tests be sitting on the shelf at your corner pharmacy right now? Patient self-testing and screening kits continue to garner the approvals of Consumer Reports’ medical advisors.

That’s happening because the Food and Drug Administration (FDA) continues to clear many do-it-yourself tests that traditionally were performed in medical laboratories by qualified personnel, much to the chagrin of some doctors.

Empowered healthcare consumers are checking their cholesterol, monitoring their diabetes, and more, using health screening kits that range from $8 to $175, according to a Consumer Reports on Health article, which advised consumers to use self-tests judiciously and share the results with their physicians. (more…)

Wireless Patient Monitoring and Diagnostic Systems Using MBANs Should Be on the Radar Screens of Pathologists and Clinical Laboratory Professionals

Experts are excited about the swift development of wireless remote monitoring of patients; companies expected to develop sensors that incorporate a wide range of biomarkers

Some experts predict that the era of wireless, remote monitoring of patients is almost upon us. It will require pathologists and medical laboratory professionals to learn a new acronym: MBAN, which stands for medical body area network.

There is keen interest in remote wireless monitoring systems. The concept is to free patients from the hospital bed and allow continuous remote monitoring, regardless of where the patient is located. For this reason, in just a few years and in many local markets, opportunities are likely to be ripe for pathologists and clinical laboratory teams to have a role in managing wireless medical devices that use MBANs. (more…)

Anticipating the Digital Medicine Revolution, Scripps Doctor Prescribes Smartphone Apps as Frequently as Medications

Pathologists will want to engage with physicians as wireless devices and smartphone apps make it possible to maintain continuous surveillance of the body

Pathologists might want to borrow a page from a tech-savvy doctor who was voted the “Most Influential Physician Executive” in 2012. A cardiologist, this physician says he now prescribes mobile applications for his patients almost as frequently as he prescribes therapeutic drugs.

Many clinical laboratory managers will recognize the name of Eric Topol, M.D., who is the Director of the Scripps Translational Science Institute, Professor of Genomics at the Scripps Research Institute, and Chief Academic Officer at Scripps Health, all located in La Jolla, California. Topol has a passion for wireless medical technology. Moreover, he is nationally recognized as a wireless medical technology trailblazer, as well as for his medical expertise.

In fact, in one news clip, NBC News touts him as the nation’s foremost expert in the explosion of wireless medicine. Topol was also selected by GQ Magazine in 2009 as one of the nation’s 12 “Rock Stars of Science.” (more…)

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