Australian government rules lab employee’s rogue actions jeopardized patient care
In an example of “if something can go wrong in the lab, it will,” a senior histology laboratory worker at Royal North Shore Hospital in Sydney, Australia, has been banned for life from providing health services for allegedly swapping patient tissue samples in an attempt to harm a lab co-worker, according to The Sydney Morning Herald.
Dianne Reader, 61, was a “a senior technical officer at the Anatomical Pathology Laboratory with more than 40 years’ experience,” the Herald noted, adding that Reader “had swapped 20 patient tissue samples, leading to the misdiagnosis of at least one patient.”
Her motivation, the Herald reported, was to “target and discredit her colleague.”
“Ms. Reader repeatedly engaged in conduct that demonstrated a flagrant disregard for patient health and safety” that may have “serious adverse consequences for the patients involved,” Tony Kofkin at Australia’s Health Care Complaints Commission told The Sydney Morning Herald. This is a lesson that clinical laboratory managers can never be too diligent because something unexpected can happen at any moment—and these events have the potential to cause serious patient harm. (Photo copyright: LinkedIn.)
Lab Staff Suspicions Raised
The sample mixups began in 2020, when the targeted employee (employee A) was working specimen “cut-up” duty. After two incidents of sample mixups being found in her work, she was removed from the duty for three weeks. The Herald reported that the employee told a co-worker she believed she was being “framed.” When she returned to cut-up duty, she took photographs of her work as a precautionary measure.
The employee’s photos served as evidence when that day’s work again showed errors, now the third incident of sample mixups. Upon further research, a total of four occasions of swapping samples were discovered between March and June of 2020.
Laboratory records showed that Reader was responsible for unpacking the tissue processor on each of those occasions, the Herald noted.
Lab workers noted a strained working relationship between Reader and the targeted employee. “One co-worker, a hospital scientist, told the [Health Care Complaints Commission] the working relationship between Reader and ‘Employee A’ could be ‘frosty,’” the Herald reported.
Lab staff apparently grew suspicious when a co-worker discovered that Reader “was only looking up gall bladder and appendices samples on the mornings Employee A had been ‘cutting up’ (dissecting and describing samples before placing them into cassettes for processing).” Lab staff also confirmed to the Health Care Complaints Commission that Reader had improperly accessed 43 patient records, adding that “there was no reason for her to have accessed the records when she did,” The Sydney Morning Herald reported.
Reader, according to the Herald, “denied she had ever interchanged specimens or improperly accessed patient files in two recorded interviews in July 2020, and maintains her innocence.”
Nevertheless, Tony Kofkin, the Commission’s complaint operations Executive Director, found that Reader “posed a risk to the health and safety of the public because she was prepared to risk patient safety in order to discredit her colleague.
“Ms. Reader repeatedly engaged in conduct that demonstrated a flagrant disregard for patient health and safety,” he wrote in the Commission’s findings, adding that Reader “had shown no remorse or insight into her conduct ‘despite the overwhelming evidence’ and as such posed a permanent risk to the health and safety of the public,” the Herald reported.
The Health Care Complaints Commission determined that Reader’s actions were “motivated by a desire to target and discredit her colleague.” The Commission’s decision prevents Reader from forever providing healthcare services, including medical, hospital, pharmaceutical, forensic pathology, or health education services, according to the Herald.
Who Was Harmed by the Swapped Samples?
Reader’s alleged actions had significant consequences. One patient’s swapped sample nearly led her to having a hysteroscopy for a glandular polyp, when in fact she was suffering with endometrial hyperplasia. Thankfully, the histology laboratory staff discovered the mistake and quickly contacted the patient’s doctor to ensure the proper surgery was performed, the Herald noted.
Things could have gone much worse for that patient and for others. Clinical laboratory managers should look upon this as a cautionary tale and consider how to ensure similar—and very rare—occurrences do not happen in their own laboratories.
In preparing to deal with outbreaks of three different respiratory viruses, measures include newly approved vaccines for RSV and reformulated COVID-19 shots
Clinical laboratories are the frontline of testing for respiratory infections, and as such, were heavily involved in last winter’s so-called “tripledemic” of Influenza, SARS-CoV-2, and respiratory syncytial virus (RSV). According to a Kaiser Family Foundation (KFF) survey, 38% of US households were affected. Now, federal health officials are taking steps to prevent a repeat tripledemic season, which includes new vaccines for RSV as well as reformulated COVID-19 vaccines.
The big breakthrough this year is the federal Food and Drug Administration’s (FDA) first-ever approval of RSV vaccines in the US. On May 3, the FDA approved GSK’s Arexvy for use in adults 60 years or older. Then, on May 31, the agency approved Pfizer’s Abrysvo for use in the same age group.
“Older adults, in particular those with underlying health conditions such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), in an FDA statement announcing approval of the GSK vaccine. “[The] approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”
A GSK press release notes that a clinical trial is underway to evaluate the vaccine for adults aged 50 to 59.
“The number of elders who die of viral infection every winter in our intensive care units, and also sometimes in the summer, is large—it’s in the tens of thousands of individuals,” pediatrician Ofer Levy MD, PhD (above), an advisor to the FDA, told The New York Times. “Each of these vaccines is a huge win.” Clinical laboratories will be looking for these new vaccines to help protect their customers from tripledemic infections. (Photo copyright: Harvard.)
As of early June, XBB lineages accounted for more than 95% of the SARS-CoV-2 variants circulating in the US, noted a recommendation from the VRBPAC committee. The recommendation also noted that the XBB 1.16 and 2.3 variants are on the rise as XBB 1.5 is declining, but “the protein sequences of XBB.1.5, XBB.1.16, and XBB.2.3 spike protein appear similar, with few amino acid differences. Available evidence suggests little to no further immune evasion from these new substitutions in the XBB.1.16 spike protein compared to XBB.1.5.”
The committee recommended a monovalent vaccine composition in contrast to the current bivalent vaccines, which have separate components targeting the original coronavirus strain and the Omicron variant.
Experts Differ on How Best to Administer New Vaccines
One question is whether the three vaccines—COVID-19, RSV, Influenza—should be given in a single visit or spread out. FDA advisor and pediatrician Ofer Levy MD, PhD, told The New York Times that bundling the shots could result in higher rates of immunization. “Plus, you want to get these shots in arms before the viral respiratory season in the winter,” he said. Levy is Director of the Precision Vaccines Program at Boston Children’s Hospital and Professor of Pediatrics at Harvard Medical School.
However, advisors to the federal Centers for Disease Control and Prevention (CDC) have warned that administering the flu and RSV vaccines at the same time could make both less effective. “I would say, when possible, it might be good to spread them out,” Camille Kotton, MD, Clinical Director of Transplant and Immunocompromised Host Infectious Diseases in the Infectious Diseases Division at Massachusetts General Hospital, told The New York Times. “I remain clinically concerned, especially where influenza vaccine doesn’t engender as much protection as we might like,” she said.
Looking Back at Last Winter
Just how bad was the last triple outbreak? In the KFF survey, 38% of respondents said their households were affected by at least one of the three diseases in the previous month:
27% reported someone in their household having the flu,
“News about the three viruses also made some people more likely to take preventive measures such as:
Wearing a mask in public (31%),
Avoiding large gatherings (26%),
Traveling less (20%),
Avoiding eating indoors at restaurants (18%).”
Additionally, people with compromised immune systems were more likely to take precautions, as were Black and Hispanic adults, KFF reported.
Clinical laboratories will soon have new vaccines to combat another potential tripledemic. Whether people will line up to receive them is another matter.
In partnership with the CDC, the collected samples will be sent to approved clinical laboratories for testing as a way to monitor for traces of the SARS-CoV-2 virus
Microbiologists and virologists engaged in tracing sources of viral infections will be interested to learn that the San Francisco International Airport (SFO), in partnership with the Centers for Disease Control and Prevention (CDC), has launched a clinical laboratory testing program where wastewater from airplanes will be screened to search for traces of emerging SARS-CoV-2 coronavirus variants, the virus responsible for COVID-19 infections.
SFO announced in a press release that it is “The first airport in the United States to launch a CDC program to continuously monitor airplane wastewater samples from the onsite [airline waste] triturator for variants of SARS-CoV-2,” adding, “Concentric by Ginkgo, the biosecurity and public health unit of Boston-based synthetic biology company Ginkgo Bioworks, has installed an automatic sampling device that regularly collects combined wastewater flows from international arriving flights at SFO. These samples are then sent to an approved clinical laboratory for testing.”
This is another example of how the COVID-19 pandemic triggered advances in technologies that detect infectious diseases earlier using various samples—and access to different sources of samples—that have been historically used in the field of public health.
“This program is critical for early detection and filling in many blind spots in global surveillance,” Cindy Friedman, MD, Chief of the Travelers’ Health Branch at the CDC, told Time. Clinical laboratories approved for the SFO/CDC screening program will receive the samples for testing. (Photo copyright: NAFSA.)
CDC Program That Monitors International Travelers for Disease
When SFO wastewater samples test positive for the SARS-CoV-2 virus, scientists will perform genome sequencing on the samples to identify which variant of the pathogen is present. This process takes five to seven days. The results are then reported to the CDC.
“As we know from the COVID-19 pandemic, pathogens can spread quickly across the globe, impacting travel and trade,” said Cindy Friedman, MD, Chief of the Travelers’ Health Branch of the CDC’s Division of Global Migration and Quarantine in an SFO press release. “Testing of airplane wastewater can provide early detection of new COVID-19 variants and other pathogens that can cause outbreaks and pandemics. CDC appreciates the collaboration with SFO to further enhance these efforts.”
Concentric by Ginkgo has installed an automatic device that will collect wastewater samples from various international flights upon arrival at SFO. Those samples will then be sent to a diagnostic laboratory where they will be examined for traces of known and unknown viruses, including new variants of SARS-CoV-2.
“It’s a little gross when you start thinking about it,” epidemiologist Katelyn Jetelina, PhD, a scientific consultant for the CDC, told CNN. “But these are really long flights, and we would expect the majority of people would go to the bathroom.”
Other Airports Conducting CDC Screening
The CDC’s Traveler-based Genomic Surveillance (TGS) program was introduced in 2021 to monitor international travelers entering the US for variants of the SARS-CoV-2 coronavirus. Volunteers participate by providing nasal swabs that get batched into pools at the airport. The pooled samples are then sent to Ginkgo’s lab network where they undergo polymerase chain reaction (PCR) testing. All positive samples then receive genomic sequencing.
According to the CDC website, 110,000 volunteers participated in TGS nasal swab testing between November 2021 and February of this year. During that same period, 2,700 positive pools were sequenced and the samples shared with the CDC for viral characterization.
There are currently seven airports in the US participating in the voluntary TGS initiative. In addition to SFO, the other airports in the CDC program are:
John F. Kennedy International Airport
Newark Liberty International Airport
Hartsfield-Jackson Atlanta International Airport
Los Angeles International Airport
Seattle-Tacoma International Airport
Washington Dulles International Airport
However, at this time, SFO is the only airport where wastewater from aircrafts is being tested for coronavirus variants.
Wastewater Best Way to Assess Infections in Community
“Biology doesn’t respect borders, and airports and other ports of entry are critical nodes for monitoring the spread of pathogens,” said Matthew McKnight, General Manager, Biosecurity, at Ginkgo Bioworks, in the SFO press release. “We are proud to partner with SFO on developing cutting-edge biosecurity technology to support public health.”
Because traces of the virus that causes COVID-19 can be detected in human fecal matter, even if symptoms are not present, wastewater sampling will continue to be an important tool in the fight against the coronavirus.
“Wastewater surveillance is really the best way to assess infections in the community because people just aren’t testing as much due to the relaxing of testing requirements and a rise in testing fatigue, among other factors,” Ashish Jha, MD, a general internist physician and White House Coronavirus Response Coordinator, told CNN.
“So, when I look at data every day on trying to assess where we are with infections, I look at wastewater data,” he added.
And so, since clinical laboratories will continue to be relied upon for sample testing and population health screenings, we will continue to monitor and report on advances in wastewater testing for SARS-CoV-2, as well as other infectious agents that might be added to these sampling programs.
Research could lead to new microbiome assays that clinical laboratories could use to identify genetic and other health conditions in developing baby
It would seem to be common sense, but now a study conducted by the Broad Institute of MIT and Harvard confirms that a pregnant mother’s microbiome has an effect on the development of her baby’s own gut microbiota. These findings could create opportunities for clinical laboratories to help in diagnosing a broader range of health conditions by testing the gut bacteria of pregnant mothers.
The Broad Institute’s study suggests the mother’s gut microbiome helps form the baby’s gut bacteria not only during pregnancy and birth, but into the baby’s first year of life as well.
“This study helps us better understand how the rich community of microbes in the gut initially forms and how it develops during infancy,” said Tommi Vatanen, PhD, a co-first author on the study who is now a researcher and associate professor at the University of Helsinki, in a Broad Institute news release. “The microbiome is very dynamic and develops along with other systems, so there’s a lot going on in the first years of life.”
“We’ve shown that the maternal microbiome plays an important role in seeding the infant microbiome, and that it’s not a one-time event, but a continuous process,” said gastroenterologist and senior study author Ramnik Xavier, MD, of the Broad Institute. Clinical laboratories and microbiologists may soon have new tools for testing a mother’s microbiome during pregnancy. (Photo copyright: Maria Nemchuk, Broad Institute.)
Study Highlights Physiological Connection Between Mother and Child
This study, according to the Broad Institute news release, is the “first to uncover large-scale horizontal gene transfer events between different species of maternal and infant gut bacteria.” The researchers also found that the bacteria in the mother’s microbiome “donate” genes that go into the bacteria of her unborn child. The mother’s genes help the baby in other ways as well during pregnancy and after birth.
“Benign bacteria in the maternal gut share genes with the child’s intestinal microbes during early life, potentially contributing to immune and cognitive development,” states the news release, adding, “The microbiomes of the mother and baby change during pregnancy and the first year of life … some bacteria in the mother’s gut donate hundreds of genes to bacteria in the baby’s gut. These genes are involved in the development of the immune and cognitive systems and help the baby to digest a changing diet as it grows.”
The study also sheds light on a baby’s unique metabolites (chemicals produced by bacteria) and how they connect with the mother’s microbiome.
“This is the first study to describe the transfer of mobile genetic elements between maternal and infant microbiomes,” gastroenterologist Ramnik Xavier, MD, Core Institute Member, Director of the Immunology Program, and Co-Director of the Infectious Disease and Microbiome Program at the Broad Institute, told Neuroscience News.
“Our study also, for the first time, integrated gut microbiome and metabolomics profiles from both mothers and infants and discovered links between gut metabolites, bacteria, and breastmilk substrates,” he added.
Researchers Use Multiomics
The human microbiome influences health in many ways. For several years, Broad Institute scientists have been trying to better understand the human microbiome and the role it plays in diseases like type 1 diabetes, cancer, and inflammatory bowel disease.
According to the organization’s website, the scientists recently began using multiomics techniques in their research that include:
Xavier and his colleagues were particularly interested in the development of the microbiome during the first year of the baby’s life.
“The perinatal period represents a critical window for cognitive and immune system development, promoted by maternal and infant gut microbiomes and their metabolites,” the researchers wrote in Cell. “Here, we tracked the co-development of microbiomes and metabolomes from late pregnancy to one year of age using longitudinal multiomics data.”
The researchers deployed bacterial DNA sequencing from stool samples of 70 mother and child pairs.
They found “hundreds of genes” in the infant gut bacterial genome that originated in the mother. According to the scientists, this suggests a mother does not transfer her genes all at once during childbirth. Instead, it likely occurs in an “ongoing” gene transfer from mother to baby through the baby’s first year of life, the news release explains.
Here are details on the study findings, according to Neuroscience News:
Genes associated with diet were involved in the “mother-to-infant interspecies transfer of mobile genetic elements.”
Infant gut metabolomes were less diverse than maternal metabolomes.
Infants had 2,500 unique metabolites not detected in the mothers.
Infants that received baby formula had distinct metabolites and cytokine signatures as compared to those receiving breast milk.
A link between pregnancy and an increase in steroid compounds could be due to impaired glucose tolerance in mothers.
“We also found evidence that prophages—dormant bacteriophages (viruses that reside on bacterial genomes)—contribute to the exchange of mobile genetic elements between maternal and infant microbiomes,” Xavier told Neuroscience News.
Research Could Lead to New Clinical Laboratory Assays
Microbiologists and clinical laboratory scientists are gaining a deeper understanding of the role gut bacteria play in many aspects of human life. But how a mother’s microbiome influences a baby’s development during and after birth is particularly intriguing.
“We’ve shown that the maternal microbiome plays an important role in seeding the infant microbiome, and that it’s not a one-time event, but a continuous process,” said Xavier in the Broad Institute news release. “This may be yet another benefit of prolonged bonding between mother and child, providing more chances for these beneficial gene transfer events to occur.”
Pediatricians, microbiologists, and clinical laboratories may one day have new microbiome assays to help identify a broad range of health conditions in mothers and infants and explore gut bacteria’s effects on a baby’s developing health.
Microbiology team has tracked 37 unique strains of the coronavirus since they began researching lineages two years ago
Microbiologists and clinical laboratory scientists will be interested to learn about the discovery of a new strain of SARS-CoV-2, the coronavirus that caused the COVID-19 pandemic, in wastewater sampled in Ohio.
According to an article published in Nature Reviews Genetics, a CVG is “a genetic variation that normally has little or no effect on phenotype but that—under atypical conditions that were rare in the history of a population—generates heritable phenotypic variation.”
Johnson tracked the lineage of the cryptic strain to Ohio, where it appears to have originated from one individual who travels regularly between the cities of Columbus and Washington Court House. He believes this person may have a form of long COVID and is unaware that he or she is infected with the coronavirus.
“This person was shedding thousands of times more material than a normal person ever would,” Johnson told The Columbus Dispatch. “I think this person isn’t well. … I’m guessing they have GI issues.”
“If someone has this infection, the chances are nil that they’re going to figure out what it is,” Marc Johnson, PhD, Professor of Molecular Microbiology and Immunology at the University of Missouri School of Medicine, told Insider. Microbiologists and clinical laboratory scientists in the Columbus, Ohio, area may be able to help locate this person. (Photo Copyright: University of Missouri.)
Other Cryptic COVID-19 Lineages
This isn’t the only “Cryptic COVID” case identified by Johnson and his team. In Wisconsin, another unique strain was discovered and narrowed down to a single facility and about 30 individuals. Two thirds of the employees were tested but, unfortunately, all tests came back negative. The cryptic strain seemed to have disappeared.
“We don’t know why,” Johnson told The Hill. “Either [the infected person] left the job, or got better, or is in remission—we don’t know. But we’re still monitoring it. And we’ve actually now gotten started collecting stool samples from the company.”
“We systematically sampled [sewer] maintenance holes to trace the Wisconsin lineage’s origin. We sequenced spike RBD [receptor-binding domain] domains, and where possible, whole viral genomes, to characterize the evolution of this lineage over the 13 consecutive months that it was detectable.
“The high number of unusual mutations found in these wastewater-specific cryptic sequences raises the possibility that they originate from individual prolonged shedders or even non-human sources. The Wisconsin lineage’s persistence in wastewater, single-facility origin, and heavily mutated Omicron-like genotype support the hypothesis that cryptic wastewater lineages arise from persistently infected humans.”
Johnson and his team have tracked 37 unique strains of the COVID-19 virus, including one in New York City, The New York Times reported.
In a statement to The Columbus Dispatch regarding the Columbus strain, the federal Centers for Disease Control and Prevention (CDC) noted that, “The virus lineage in question is not currently spreading or a public health threat.
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the general population,” the CDC noted. “This can be because of a compromised immune system. CDC and other institutions conduct studies in immunocompromised individuals to understand persistent infection and virus evolution.”
In identifying these lineages, and the individuals who shed them, scientists can learn more about how COVID-19 mutates and spreads.
Mitigating Consequences of COVID-19 Variants
Although the CDC says that particular strain is not a threat to the public it could pose a long-term health risk for the individual suffering. And this individual may hold clues for the future of how the COVID-19 virus mutates and grows. Therefore, locating these people is a priority.
“The coronavirus will continue to spread and evolve, which makes it imperative for public health that we detect new variants early enough to mitigate consequences,” Rob Knight, PhD, Founding Director of the Center for Microbiome Innovation and Professor of Pediatrics, Computer Science and Engineering at the University of California San Diego (UCSD).
“Before wastewater sequencing, the only way to do this was through clinical testing, which is not feasible at large scale, especially in areas with limited resources, public participation, or the capacity to do sufficient testing and sequencing,” said Knight in a UCSD press release. “We’ve shown that wastewater sequencing can successfully track regional infection dynamics with fewer limitations and biases than clinical testing to the benefit of almost any community.”
Although tracing the individuals shedding cryptic COVID-19 lineages may not have an immediate effect on public health, it could lead to future discoveries about the SARS-CoV-2 coronavirus that can help shape public health goals in fighting future pandemics.
At the very least, one individual in Columbus may learn how to treat long COVID’s adverse symptoms. Microbiologists and clinical laboratory scientists involved in COVID-19 wastewater research can learn much from following these research investigations.
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.
“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.
