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Fireside Chat: Exploring the Intersections and Opportunities with Big Data, Precision Medicine, and Artificial Intelligence in Diagnostics and Clinical Care

Presented by: Michael Simpson, Joseph Mossel, Leo Grady, Ajit Singh Fireside Chat: Exploring the Intersections and Opportunities with Big Data, Precision Medicine, and Artificial Intelligence in Diagnostics and Clinical Care by Michael Simpson, Joseph Mossel, Leo Grady, Ajit Singh PDF copy of the Presentation Slides...

Precision Medicine May Have a New Lung Cancer Treatment That Can Be Staged with an EGFR Test as a Companion Diagnostic

There’s evidence that a cancer drug can cut deaths from lung cancer by as much as 50% when pathology testing indicates the patient has the EGFR mutation

Results from a decade-long clinical trial indicate that lung cancer patients with the epidermal growth factor receptor (EGFR) mutation have significantly better survival rates when treated with the drug osimertinib. This is a positive step forward for precision medicine and will give clinical laboratories an opportunity to deliver more value to physicians and patients.

The study known as ADAURA was led by scientists at Yale University and funded by British pharmaceutical/biotechnology company AstraZeneca. The researchers recently found that taking the cancer drug osimertinib (brand name Tagrisso) reduces by half the number of deaths among patients who had undergone surgery for EGFR–mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), according to NBC News.

Lung cancer has been one of the toughest types of cancers to diagnose early. When finally diagnosed, many patients do not have a good prognosis. Thus, the results of this multi-national study—and the connection involving patients with the EGFR gene—is a welcome development that promises better outcomes for cancer patients.

At the same time, this increases the value of EGFR as a biomarker for clinical laboratories and pathology groups that offer EGFR testing. It could become a companion diagnostic test—part of a clinical guideline for diagnosing lung cancer—that helps identify appropriate anti-cancer drugs for specific patients.

The researchers published their findings in the New England Journal of Medicine (NEJM) titled, “Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC.” They also presented the results of their study at the American Society for Clinical Oncology (ASCO) conference.

“Adjuvant osimertinib is currently the only EGFR tyrosine kinase inhibitor to translate a statistically significant and practice-changing disease-free survival benefit into a significant [overall survival] benefit in a phase 3 trial, supporting osimertinib as the standard of care for patients in this setting,” said Roy Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center, who led the Yale study, at the 2023 ASCO Annual Meeting, according to an ASCO news release. (Photo copyright: Yale School of Medicine.)

Identifying Best Candidates for Specific Cancer Drugs

The results of the Yale-led study of the cancer drug osimertinib suggest that testing for a mutation in the EGFR gene could become part of the standard-of-care for NSCLC. Researchers found that NSCLC patients with the mutation showed improved survival rates and reduced risk of recurrence when taking the drug following surgery. EGFR tests could thus become companion diagnostics to determine whether patients are good candidates for the drug.

“We have been using one-size-fits-all adjuvant chemotherapy for every patient with lung cancer despite a decade of advances in targeted treatments for select groups of patients that result in dramatically better outcomes,” Nathan Pennell, MD, PhD, Vice Chair of Clinical Research and Director, Lung Cancer Medical Oncology Program Cleveland Clinic Taussig Cancer Institute, told the ASCO Post.

Pennell, who was not involved in the Yale research, described the finding as “a first for the lung cancer field,” and said adjuvant osimertinib “should be the new standard of care” for patients with EGFR-mutated NSCLC.

‘Practice-changing’ Cancer Drug

The study was led by Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Assistant Dean for Translational Research at Yale School of Medicine. Herbst is the principal investigator for the ADAURA global multi-site clinical trial which enrolled 682 patients with stage IB-IIIA NSCLC, in an effort to determine the efficacy of the cancer drug osimertinib, a pill taken once a day, which, according to NBC News, has fewer major side effects than chemotherapy.

The FDA approved the drug in 2015 for patients with advanced lung cancer. In 2020, the agency approved its use at earlier stages of the disease.

The ADAURA study included patients from 26 countries across Europe, North America, South America, and the Asia-Pacific region. About half of the patients took the pill each day for three years following surgery. The other half received a placebo.

According to a Yale news release, the researchers reported that 88% of patients treated with the drug were still alive five years later, compared with 78% of patients who received the placebo.

Earlier research demonstrated that the drug prevented recurrence of tumors and kept the disease from spreading to other organs, NBC News reported. “However, what we are seeing now is that patients will also live longer,” said oncologist Charu Aggarwal, MD, MPH, of the University of Pennsylvania’s Perelman School of Medicine, who was not involved in the study.

Herbst described the drug as “practice-changing” in the Yale news story.

An EGFR ‘Off Switch’

Non-small cell lung cancer is the most common form of lung cancer, The Guardian reported, adding that the EGFR mutation “is found in about a quarter of global lung cancer cases, and accounts for as many as 40% of cases in Asia. An EGFR mutation is more common in women than men and in people who have never smoked or have been light smokers.”

The mutation can cause cells to “excessively divide and multiply, which may cause cancer,” NBC News explained. Herbst described osimertinib as an “off” switch for the mutation.

“I think we’re curing some patients,” he said at the ASCO annual meeting, NBC News reported. “We’re really showing progress in lung cancer like never before,” he noted, adding that the results were “about twice as good as we expected.

“Overall survival has historically been considered the gold standard efficacy endpoint for randomized adjuvant clinical trials. The results of the ADAURA trial will broaden treatment access for patients with EGFR-mutated NSCLC,” Herbst told ASCO Post. “Together with the practice-changing disease-free survival data from our primary analysis, the overall survival benefit instills confidence that adjuvant osimertinib is the standard of care for patients with resected EGFR-mutated stage IB to IIIA NSCLC.”

Side effects of the pill include skin rashes and mild diarrhea, but in general the drug is “quite well tolerated,” Herbst said.

Impact on Labs

In Herbst’s view, the results of the Yale study demonstrate that patients diagnosed with lung cancer should be tested for the EGFR mutation, which is not always the case, The Guardian reported. “This further reinforces the need to identify these patients with available biomarkers at the time of diagnosis and before treatment begins,” he said.

Aggarwal agreed, telling NBC News that data from the study could be a “call to action” for more EGFR screening.

In light of the results, clinical laboratories and anatomic pathology groups should expect that EGFR screening may soon become a companion diagnostic test as part of a precision medicine clinical guideline for early diagnosing of lung cancer.

—Stephen Beale

Related Information:

Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC

Study Shows Osimertinib Improves Survival Following Surgery for Non-Small Cell Lung Cancer

Lung Cancer Deaths Cut in Half with AstraZeneca Pill, Large Trial Finds

Adjuvant Osimertinib Improves Survival in Patients with Resected EGFR-Mutated NSCLC

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumor Resection With or Without Adjuvant Chemotherapy. (ADAURA)

ADAURA Trial Results Provide New Hope for Patients with Early-Stage Non-Small Cell Lung Cancer

Updated Results from the ADAURA Trial: Continued Disease-Free Survival Benefit with Adjuvant Osimertinib vs Placebo in EGFR-Mutated Stage IB–IIIA NSCLC

Final ADAURA OS Analysis Reinforces Adjuvant Osimertinib as a Standard of Care for Patients with Stage IB to IIIA EGFR-Mutated Non–Small Cell Lung Cancer

NIH: Stage IIIA Non-Small Cell Lung Cancer

Lung Cancer Pill Cuts Risk of Death by Half, Says ‘Thrilling’ Study

Tagrisso Demonstrated Strong Overall Survival Benefit in the ADAURA Phase III Trial for Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Executive War College Headliners Connect Genetic Testing, Wearable Technology, Precision Medicine, and Struggle Over Claim Reimbursement between Clinical Labs and Payers

Keynote speakers advise clinical laboratory leaders to leverage diagnostic data that feeds precision therapies

At this week’s Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans, keynote presenters dissected ways that clinical laboratory leaders and anatomic pathologists can contribute to innovative treatment approaches, including wearable technology and precision medicine.

The speakers also noted that labs must learn to work collaboratively with payers—perhaps through health information technology (HIT)—to establish best practices that improve reimbursements on claims for novel genetic tests.

Harnessing the ever-increasing volume of diagnostic data that genetic testing produces should be a high priority for labs, said William Morice II, MD, PhD, CEO and President of Mayo Clinic Laboratories.

“There will be an increased focus on getting information within the laboratory … for areas such as genomics and proteomics,” Morice told the keynote audience at the Executive War College on Wednesday.

William Morice II, MD, PhD

“Wearable technology data is analyzed using machine learning. Clinical laboratories must participate in analyzing that spectrum of diagnostics,” said William Morice II, MD, PhD (above), CEO and President of Mayo Clinic Laboratories. Morice spoke during this week’s Executive War College.

Precision Medicine Efforts Include Genetic Testing and Wearable Devices

For laboratories new to genetic testing that want to move it in-house, Morice outlined effective first steps to take, including the following:

  • Determine and then analyze the volume of genetic testing that a lab is sending out.
  • Research and evaluate genetic sequencing platforms that are on the market, with an eye towards affordable cloud-based options.
  • Build a business case to conduct genetic tests in-house that focuses on the long-term value to patients and how that could also improve revenue.

Morice suggested that neuroimmunology is a reasonable place to start with genetic testing. Mayo Clinic Laboratories found early success with tests in this area because autoimmune disorders are rising among patients.

A related area for clinical laboratories and pathology practices to explore is their role in how clinicians treat patients using wearable technology.

For example, according to Morice, Mayo Clinic has monitored 20,000 cardiac patients with wearable devices. The data from the wearable devices—which includes diagnostic information—is analyzed using machine learning, a subset of artificial intelligence.

In one study published in Scientific Reports, scientists from Mayo’s Departments of Neurology and Biomedical Engineering found “clear evidence that direct seizure forecasts are possible using wearable devices in the ambulatory setting for many patients with epilepsy.”

Clinical laboratories fit into this picture, Morice explained. For example, depending on what data it provides, a wearable device on a patient with worsening neurological symptoms could trigger a lab test for Alzheimer’s disease or other neurological disorders.

“This will change how labs think about access to care,” he noted.

For Payers, Navigating Genetic Testing Claims is Difficult

While there is promise in genetic testing and precision medicine, from an administrative viewpoint, these activities can be challenging for payers when it comes to verifying reimbursement claims.

“One of the biggest challenges we face is determining what test is being ordered. From the perspective of the reimbursement process, it’s not always clear,” said Cristi Radford, MS, CGC, Product Director at healthcare services provider Optum, a subsidiary of UnitedHealth Group, located in Eden Prairie, Minnesota. Radford also presented a keynote at this year’s Executive War College.

Approximately 400 Current Procedural Terminology (CPT) codes are in place to represent the estimated 175,000 genetic tests on the market, Radford noted. That creates a dilemma for labs and payers in assigning codes to novel genetic tests.

During her keynote address, Radford showed the audience of laboratory executives a slide that charted how four labs submitted claims for the same high-risk breast cancer panel. CPT code choices varied greatly.

“Does the payer have any idea which test was ordered? No,” she said. “It was a genetic panel, but the information doesn’t give us the specificity payers need.”

In such situations, payers resort to prior authorization to halt these types of claims on the front end so that more diagnostic information can be provided.

“Plans don’t like prior authorization, but it’s a necessary evil,” said Jason Bush, PhD, Executive Vice President of Product at Avalon Healthcare Solutions in Tampa, Florida. Bush co-presented with Radford.

[Editor’s note: Dark Daily offers a free webinar, “Learning from Payer Behavior to Increase Appeal Success,” that teaches labs how to better understand payer behavior. The webinar features recent trends in denials and appeals by payers that will help diagnostic organizations maximize their appeal success. Click here to stream this important webinar.]

Payers Struggle with ‘Explosion’ of Genetic Tests

In “UnitedHealth’s Optum to Offer Lab Test Management,” Dark Daily’s sister publication The Dark Report, covered Optum’s announcement that it had launched “a comprehensive laboratory benefit management solution designed to help health plans reduce unnecessary lab testing and ensure their members receive appropriate, high-quality tests.”

Optum sells this laboratory benefit management program to other health plans and self-insured employers. Genetic test management capabilities are part of that offering.

As part of its lab management benefit program, Optum is collaborating with Avalon on a new platform for genetic testing that will launch soon and focus on identifying test quality, streamlining prior authorization, and providing test payment accuracy in advance.

“Payers are struggling with the explosion in genetic testing,” Bush told Executive War College attendees. “They are truly not trying to hinder innovation.”

For clinical laboratory leaders reading this ebriefing, the takeaway is twofold: Genetic testing and resulting precision medicine efforts provide hope in more effectively treating patients. At the same time, the genetic test juggernaut has grown so large so quickly payers are finding it difficult to manage. Thus, it has become a source of continuous challenge for labs seeking reimbursements.

Heath information technology may help ease the situation. But, ultimately, stronger communication between labs and payers—including acknowledgement of what each side needs from a business perspective—is paramount. 

Scott Wallask

Related Information:

Executive War College Keynote Speakers Highlight How Clinical Laboratories Can Capitalize on Multiple Growth Opportunities

What Key Laboratory Leaders Will Learn at This Week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

Ambulatory Seizure Forecasting with a Wrist-Worn Device Using Long-Short Term Memory Deep Learning

UnitedHealth’s Optum to Offer Lab Test Management

Learning from Payer Behavior to Increase Appeal Success

University College London Uses 3D Printers to Create Custom Prescriptions, What Does That Mean for Clinical Laboratories and Precision Medicine?

As 3D printing technology gains acceptance with pharmaceutical companies, clinical laboratories could see increased demand for pharmacogenomic testing

Will physicians someday “print” prescription drugs for patients in-office? It sounds like science fiction, but research being conducted at the University College London (UCL) indicates the capability may be closer than we think, and it could bring about a new type of collaboration between clinical laboratories, ordering physicians, and pharmacies.

UCL’s new 3D technique, which it calls “volumetric 3D printing,” is intended to enable the pharmaceutical industry to tailor drug dosage, shape/size, and release to an individual patient’s needs and preference. A key element of precision medicine.

According to GlobalData Healthcare, 3D printing also can “significantly reduce cost, wastes, and economic burden as printers only deposit the exact amount of raw materials required.”

The researchers published their findings in the journal Additive Manufacturing, titled, “Volumetric 3D Printing for Rapid Production of Medicines.”

Fred Parietti, PhD

3D printing may enable pharmaceutical companies to address gender and racial disparities in prescription drug manufacturing through a developing technology that could have implications for clinical laboratory testing. Fred Parietti, PhD (above), co-founder and CEO of Multiply Labs, a technology company that develops robotics for precision medicine pharmaceuticals, told 3D Natives, “Currently, medications are developed especially for white adult men, which means that all women and children have an excessive prescription for their bodies. This fact underlines the importance of the advent of personalized medicines, as well as highlighting the individuality of each patient, since the error in the dosage of certain active ingredients can even lead to the malfunctioning of some treatments.” (Photo copyright: Multiply Labs.)


Increased Demand for Pharmacogenomic Testing

Though 3D printing of prescription drugs is not directly in the clinical laboratory/pathology space, it is noteworthy because it shows how technological advancements are progressing that actualize the ability to deliver precision medicine care to individual patients.

In turn, this could increase physician/patient demand for pharmacogenomic tests performed by clinical laboratories. The test results would be used by treating physicians to determine proper dosages for their individual patients prior to ordering 3D-printed drugs.

Being able to provide medication tailored to patients’ specific needs could bring about a revolution in pharmaceutical manufacturing. If 3D printed prescription drugs become mainstream, the demands could affect the clinical laboratory and pathology industries as well.

How Far Are We from Mass Production of 3D Printed Drugs?

The first and only 3D printed pharmaceutical drug on the American market is Spritam (levetiracetam) an anti-epileptic drug developed by Aprecia Pharmaceuticals, according to Medical Device Network. It received FDA clearance under the name Keppra in 1999.

Headquartered in Blue Ash, Ohio, Aprecia’s patented ZipDose manufacturing process allows 3D-printed pills to hold a larger dosage and dissolve rapidly. They currently have the only FDA process-validated 3D printing platform for commercial-scale drug production. They are leading the way on this new 3D technology and others are following suit.

FabRx, a start-up 3D printing company developed by academic researchers in 2014 at the University College London, released its first pharmaceutical 3D printer for personalized medicine called M3DIMAKER according to The system is “controlled by specialized software, allowing the selection of the required dose by the pharmacist according to the prescription given by the clinician,” the company’s website notes.

The technology also allows for additional customization of pills, including the application of Braille for visually impaired patients, and printing of Polypills, which combine more than one drug into a single pill.

Other company’s developing 3D printing of pharmaceuticals, according to, include:

  • Germany’s Merck: currently in clinical trials of 3D printing medication with the goal of reaching large scale production.
  • China’s Triastek: which holds “41 patents that account for more than 20% of global 3D printing pharmaceuticals applications.”
  • GlaxoSmithKline of the UK: which has partnered with the University of Nottingham to study 3D printing technology.

We are still far away from large scale production of drugs using 3D printing, but that doesn’t mean it should not be on clinical laboratory leaders’ radar.

The rise of 3D printing technology for precision medicine could lead to big changes in the pharmaceutical world and alter how patients, providers, and clinical laboratories interact. It also could increase demand for pharmacogenomic testing to determine the best dosage for individual patients. This breakthrough shows how one line of technology research and development may, as it reaches clinical use, engage clinical laboratories.

Ashley Croce

Related Information:

3D-Printed Tablets Offer Taste of Personalized Seven-Second Medicine

Volumetric 3D Printing for Rapid Production of Medicines

3D Printing of Drugs Can Revolutionize Personalized Medicine and Improve Sustainability

Are 3D Printed Drugs the Future of Personalized Medicine?

Seeing Drugs in 3D

Five Companies Personalizing Treatments with 3D Printed Drugs

The Advent of a New Era in Digital Healthcare: A Role for 3D Printing Technologies in Drug Manufacturing?

FDA: A Basic Guide to Process Validation in the Pharmaceutical Industry