Both programs seek to achieve early diagnosis by detecting a range of disorders where an existing treatment can be given as early as possible
Two separate genetic sequencing projects—one in the United Kingdom and one in New York City—aim to perform whole-genome sequencing for clinical laboratory diagnostic purposes on 100,000 newborns each to identify up to 200 rare genetic disease that are treatable with early diagnosis and intervention.
Genomics England announced its Newborn Genomes Program in 2022 and plans to start signing up expectant parents for the genetic sequencing project later this year, an article in Science reported. Parents will be invited to participate in the $129 million pilot program through the UK’s National Health Service (NHS) with the goal of enrolling 100,000 newborns over the next two years.
In the US, the Guardian Study (Genomic Uniform-screening Against Rare Diseases In All Newborns) was launched last year in New York City. The program will run for four years and sequence the DNA of 100,000 newborns looking for 160 rare genetic diseases. “Parents can opt to add 100 neurodevelopmental disorders that can’t be cured, but for which speech and physical therapy could help,” Science noted.
More than 200 babies have already been enrolled in the Guardian study, and about 70% of those invited to participate have agreed to do so, according to GenomeWeb.
“I think expanding the number of diseases we look for could make a radical improvement in the way we diagnose and treat children with rare diseases,” said molecular geneticist Wendy Chung, MD, PhD, Director of the Clinical Genetics Program at New York Presbyterian Hospital/Columbia University Medical Center, in a press release. Clinical laboratories that perform newborn screenings may soon have new genomic screening tools for a larger number of rare genetic disorders. (Photo copyright: Columbia University.)
Giving Parents the Ability to Make Informed Decisions
In many countries, newborns are screened for several dozen genetic illnesses via biochemical tests using a drop of blood collected from the baby’s heel. Whole-genome sequencing could potentially detect more disorders and allow for earlier care and treatments to avoid permanent disability or death.
Parents enrolled in the US/UK genomics sequencing programs will receive results for as many as 200 genetic diseases that are known to be caused by genetic variants and which typically display symptoms before the age of five. All the illnesses are treatable with remedies ranging from a simple vitamin supplement to a bone marrow transplant.
“For the parents who may be offered whole genome sequencing for their babies as part of our pilot, they need to know which of these many conditions will be looked for, so that they can make an informed decision about whether or not to take part in the study,” said pediatrician and geneticist David Bick, MD, Principal Clinician for the Newborn Genomes Program, in a Genomics England press release.
Parents will not receive data regarding gene variants with unknown risks or variants that only cause disease in adulthood.
Detecting a Range of Genetic Disorders in Newborns
The UK’s Newborn Genomes Program expects to identify genetic disease in at least 500 newborns. Researchers involved in the project estimate that utilizing genetic sequencing in newborns could detect those diseases in up to 3,000 babies if used across the country.
“The primary goal of the program is to detect a range of disorders where we already have an intervention that could be given at the earliest possible point in life to reduce disability or potentially to avoid harm,” said Sir Mark Caulfield, MD, Director of the William Harvey Research Institute at Queen Mary University of London and Chief Scientist for Genomics England, in a Queen Mary University press release.
“It turns out that approximately one in 190 births (circa 10 babies born every day in the UK) has one of these problems, and if the intervention is employed, this could be life changing. The majority of these interventions are dietary shifts or vitamin supplements, and only 8% are expensive treatments, for example, gene therapies or transplantation,” Caulfield noted. “The children may not be cured, but the interventions may reduce disability or even allow a normal life, so getting these life-changing opportunities to children at the earliest point is so important.”
The US initiative is using genomic sequencing to screen for 250 medical conditions that are not currently detectable in newborn screenings in New York. Like the UK program, these disorders are treatable and symptomatic before the age of five. The goal is to diagnose these illnesses earlier to allow for early treatment and better health outcomes.
“I think expanding the number of diseases we look for could make a radical improvement in the way we diagnose and treat children with rare diseases”, said Chung in a Columbia University press release. “Families and pediatricians don’t need to go through those diagnostic odysseys anymore with the genomic technology we now have. We can make the diagnosis at birth.
“I think genomic screening will also make sure we leave no baby behind. It will provide equitable access to a diagnosis,” Chung added. “We want to address health disparities, which we’ve seen happen after screening for SCID (severe combined immunodeficiency disorders) was added to state newborn screening panels. When every newborn is screened, the family’s socioeconomic status is irrelevant.”
Saving Children from Lifelong Disease
The US and UK genomics sequencing programs may have considerable influence on encouraging more newborn screening all over the world. Technological advancements in recent years have dramatically reduced genomic sequencing costs.
Additionally, sequences can be done faster and more accurately, and the technology is enabling complex analysis of data in ways that expands the information contained in the genome. This could lead to life-saving breakthroughs in treatment for many rare genetic disorders.
These developments may also encourage more clinical laboratories within the United States to consider offering a genome sequencing service for newborn screening. With hundreds of diseases now detectable through genetic technology, screening a newborn’s genome for mutations could provide more accurate and faster diagnosis of illnesses and potentially help more children avoid serious diseases.
Incident serves as a reminder that all clinical laboratories can be just one mistake away from reporting erroneous results to a number of doctors and patients
In May, more than 400 patients who agreed to take the Galleri multi-cancer early detection (MCED) blood test from GRAIL—a California-based biotechnology company that is owned by genetic technology developer Illumina—received letters falsely suggesting they had cancer, according to the Financial Times which broke the news.
The Times reported that a software error had caused GRAIL’s telemedicine provider PWNHealth, which is owned by Everly Health Solutions, to send an erroneous letter to 408 patients misinforming them that “they had a signal in their blood suggesting they could have cancer.”
In a statement, GRAIL said the letters were “in no way related to or caused by an incorrect Galleri laboratory test result” and that “the letters were inadvertently triggered by a PWNHealth software configuration issue, which had now been disabled,” Financial Times reported.
GRAIL, which stated that more than half of the people who received the letters hadn’t even had blood drawn for the test, also added that “no patient health information has been disclosed or breached due to this issue, and no patient harm or adverse events have been reported,” the Financial Times noted.
Nevertheless, it’s not hard to imagine the effect the letters had on those people. No clinical laboratory wants national headlines as a consequence of an error that causes incorrect test results to be reported to doctors and patients. How to prevent such occurrences is a challenge to all clinical laboratory managers.
According to GRAIL, its Galleri multicancer early detection test “can detect a signal shared by more than 50 cancer types and predict the tissue type or organ associated with the signal. At least 45 of these cancers lack recommended screening tests in the US today.” Clinical laboratories that draw the blood sample for the genetic test ship the collection kit directly to GRAIL’s laboratory for processing. (Photo copyright: GRAIL.)
What Went Wrong
PWNHealth said in a statement that the letters were sent due to “a misconfiguration of our patient engagement platform used to send templated communications to individuals,” CBS News reported.
Financial Times reported that the letters were issued from May 10-18, and on May 19 PWNHealth informed GRAIL of the problem. “We addressed the underlying problem within an hour of becoming aware of it and have implemented additional processes to ensure it does not happen again,” PWNHealth said. “In partnership with GRAIL, we started contacting impacted individuals within 36 hours.”
The software configuration fault was deactivated by PWNHealth, and GRAIL notified affected individuals via phone, email, and regular mail until all had been informed of the error, GRAIL said.
Though GRAIL reacted quickly, there has been fallout caused by the letters. Insurer confidence may have been damaged.
According to Financial Times, customers of life insurance company MassMutual and another unnamed insurer had “been affected” by the erroneous letters. As a result, MassMutual had suspended a pilot program and the unnamed insurer was “reviewing its relationship” with GRAIL.
About GRAIL and the Galleri Liquid Biopsy Test
GRAIL was founded in 2015 in San Francisco, California, with the goal of detecting early-stage cancer. They developed the Galleri liquid biopsy test which requires only one blood sample and can “detect a signal shared by over 50 types of cancer with 99.5% specificity and predict the cancer signal origin with high accuracy to help guide next steps,” according to the company’s website.
The $949 test can only be obtained by a doctor’s prescription. At this time it is not covered by insurance, Healthnews reported.
According to a GRAIL Galleri fact sheet, “All cells—cancer and healthy ones—shed DNA, which is called cell-free DNA (cfDNA), into the bloodstream. … After a blood sample is taken at a healthcare provider’s office or at a GRAIL partner laboratory, the Galleri test uses the power of next-generation sequencing and machine-learning algorithms to analyze cfDNA methylation patterns.
“The test uses these methylation patterns to determine if a cancer signal is present and, if so, predict the tissue type or organ where the cancer signal originated.
“If a cancer signal is detected, a healthcare provider will determine next steps for diagnostic evaluation, which may include personal and family health history, physical examination, and guideline directed evaluation(s) including lab work and imaging.”
Flashback to Another Notable Lab Error
This is not the first time inaccurate genetic test results have been sent out to patients.
In 2017, Dark Daily’s sister publication, The Dark Report, covered how genetic test developer Invitae Corporation had reported inaccurate genetic test results for up to 50,000 patients over a period of 11 months from September 2016 to July 2017.
In a statement, Invitae said the error occurred “because of the unique characteristics of how we we’re testing for the MSH2 Boland inversion, our quality control checks did not catch omission of the components of the assay. … As soon as the omission was recognized and relevant components returned to the assay, it once again performed properly. We have added two separate quality controls to ensure this issue will not reoccur.”
Negative Online Reviews Hurt Businesses including Clinical Laboratories
In its article, Status Labs references a 2021 PEW Research survey which found that “More than eight-in-10 US adults (86%) say they get news from a smartphone, computer, or tablet ‘often’ or ‘sometimes,’ including 60% who say they do so often. This is higher than the portion who get news from television, though 68% get news from TV at least sometimes and 40% do so often. Americans turn to radio and print publications for news far less frequently, with half saying they turn to radio at least sometimes (16% do so often) and about a third (32%) saying the same of print (10% get news from print publications often).”
Status Labs also cited studies showing the impact of negative press online. One study by Trustpilot showed that 90% of consumers said they will not frequent a business that has a bad reputation.
Another study by the University of Pennsylvania found that “negative reviews, messages, or rumors hurt product evaluations and reduce purchase likelihood and sales.”
Vigilance Is the Key
Clinical laboratory leaders are keenly aware that a lab’s reputation can make or break its business. This incident involving GRAIL and its telemedicine provider PWNHealth is a reminder that vendors providing services to medical laboratories can be a source of problems ranging from breaches of protected health information (PHI) to misstatements or misreporting of clinical laboratory test results.
Thus, it behooves lab managers to constantly monitor information leaving the lab, and to ensure all test results sent to patients and doctors are valid and accurate.
This research indicates consumers could increase their demand for clinical laboratory testing for genetic risk factors associated with addiction
Rutgers University researchers recently published a study of hundreds of college students that suggests there could be high future consumer demand for genetic testing related to addiction risk. What is significant is that the college students surveyed are members of Generation Z, people born between the mid-1990s and early 2010s.
Zoomers grew up knowing about the human genome, and they are likely aware of new genetic insights, new gene therapies, and new clinical laboratory tests that analyze genomic data to diagnose disease and/or identify the individual’s predisposition to certain genetic conditions.
Thus, consumer demand among Gen Z for clinical laboratories to provide such tests in the future could drive a new class of diagnostic testing that would generate a new revenue stream for clinical laboratories, while also enabling labs to deliver a value-added service to healthcare consumers and their physicians.
“Overall, the [study] results strongly encourage the notion that real genetic risk scores may prove helpful in preventing and treating alcohol addiction,” Danielle Dick, PhD, Director of the Rutgers Addiction Research Center and lead author of the study, told Neuroscience News. The results of the Rutgers study could lead to increased demand for clinical laboratory tests to determine addiction risk. (Photo copyright: Rutgers University.)
Methodology Used in Rutgers Study
To complete their study, the Rutgers researchers surveyed 325 college students and asked how they would react to learning about genetic test results indicating their risk for alcohol use disorder. The researchers found that despite the complexity of the genetic factors underlying addiction, respondents understood the connection between genetic risk and the likelihood of developing alcoholism. And most respondents indicated they would take precautions if they learned that they were at high risk.
The research “paves the way for studies using real genetic data and for integrating genetic information into prevention and intervention efforts,” the study’s lead author, Danielle Dick, PhD, Director of the Rutgers Addiction Research Center (RARC), Greg Brown Endowed Chair in Neuroscience, and Professor, Robert Wood Johnson Medical School/Psychiatry, told Neuroscience News.
The story notes that most genes associated with addiction have only been discovered recently. Commercial genetic testing services do not provide information about addiction risk, “so very few people have ever received genuine information about their genetic tendency toward addiction,” Neuroscience News noted.
The researchers obtained their data as part of a trial that sought to evaluate “the efficacy of educational information on understanding of polygenic risk scores for alcohol use disorder,” they wrote in the American Journal of Medical Genetics.
After recruiting the study participants, the researchers randomly assigned them to one of three groups:
A control group of 109 students that received no educational information.
A group of 105 students who were directed to a website with educational information about alcohol use disorder, “including a definition, consequences, and ways to reduce risk,” the researchers wrote.
A group of 111 students who were directed to a website with the same information about alcoholism, in addition to information about the role of genetics in addiction risk. This included information about “genetic variation, risk variants, how polygenic scores are created, and how they can be interpreted,” the researchers noted.
In all three groups, the survey asked respondents to imagine three hypothetical scenarios: that they had 1) a below-average genetic risk of developing alcoholism, 2) an average risk, and 3) an above-average risk.
For each level of risk, they answered a series of questions “that assessed psychological distress, perceived chance of developing alcohol use disorder, and intentions related to seeking additional information, talking to a healthcare provider, and drinking behavior,” the researchers wrote.
Results of the Rutgers Study of Genetic Risk for Alcohol Use Disorder
The researchers found that exposure to educational information had a minimal impact on the responses, which were generally consistent across all three groups.
With higher levels of risk for alcohol use disorder, respondents were more likely to indicate psychological distress, more likely to seek additional information, more likely to talk to a healthcare provider, and more likely to change drinking behaviors.
And “as the level of genetic risk increased, the perceived chance of developing alcohol use disorder significantly increased,” the researchers wrote.
Does Learning of Risk Alter Behavior?
Citing previous research, Dick said that addiction risk is roughly half determined by genetic factors, “but there’s no single addiction gene that’s either present or absent,” Dick told Neuroscience News. “Instead, there are thousands of interacting genes, so each person’s genetic risk falls somewhere on a continuum.”
The risk is distributed on a bell curve, she said, and most people fall in the middle. But despite this complexity, “study participants formed relatively accurate impressions of the risk for addiction associated with various genetic results.”
The researchers appeared to be most encouraged that the respondents indicated a willingness to take precautionary measures if they learned they had a high genetic risk of developing alcoholism.
“There was a hope that compelling information about elevated genetic risk would get people to change behavior, but we haven’t seen that happen for other aspects of health,” Dick said. “Initial studies suggest that receiving genetic feedback for heart disease, lung cancer, and diabetes does not get people to change their behavior. Getting people to alter their behavior is hard.”
Future Rutgers studies will investigate understanding of risk scores in other populations, Neuroscience News reported.
Understanding why some people display no symptoms during a COVID-19 infection could lead to new precision medicine genetic tests medical labs could use to identify people with the mutated gene
New research from the University of California San Francisco (UCSF) may explain why some people could get COVID-19 but never test positive on a clinical laboratory test or develop symptoms despite exposure to the SARS-CoV-2 coronavirus.
According to the UCSF study, variations in a specific gene in a system of genes responsible for regulating the human immune system appears to be the factor in why about 10% of those who become infected with the virus are asymptomatic.
These scientific insights did not receive widespread news coverage but will be of interest to clinical laboratory managers and pathologists who oversee SARS-CoV-2 testing in their labs.
“Some people just don’t have symptoms at all,” Jill Hollenbach, PhD (above), Professor of Neurology atUCSF’s Weill Institute for Neurosciences and lead researcher in the study, told NBC News. “There’s something happening at a really fundamental level in the immune response that is helping those people to just completely wipe out this infection.” Identifying a genetic reason why some people are asymptomatic could lead to new precision medicine clinical laboratory diagnostics for COVID-19. (Photo copyright: Elena Zhukova /University of California San Francisco.)
Fortunate Gene Mutation
According to the Centers for Disease Control and Prevention’s (CDC) COVID Data Tracker, as of April 5, 2023, a total of 104,242,889 COVID-19 cases have been reported in the United States. However, according to a CDC Morbidity and Mortality Weekly Report (MMWR), “Traditional methods of disease surveillance do not capture all COVID-19 cases because some are asymptomatic, not diagnosed, or not reported; therefore, [knowing the true] proportion of the population with SARS-CoV-2 antibodies (i.e., seroprevalence) can improve understanding of population-level incidence of COVID-19.”
She also participates in the COVID-19 HLA and Immunogenetics Consortium, a group of academic researchers, clinical laboratory directors, journal editors, and others who examine the role of HLA variations in determining COVID-19 risk.
Hollenbach’s research identified an HLA variant—known as HLA-B*15:01—that causes the human immune system to react quickly to SARS-CoV-2 and “basically nuke the infection before you even start to have symptoms,” she told NPR.
“It’s definitely luck,” she added. “But, you know, this [gene] mutation is quite common. We estimate that maybe one in 10 people have it. And in people who are asymptomatic, that rises to one in five.”
“HLA variants are among the strongest reported associations with viral infections,” the UCSF study notes. So, the researchers theorized that HLA variations play a role in asymptomatic SARS-CoV-2 infections as well.
To conduct their study, shortly after the SARS-CoV-2 outbreak in 2020, the researchers recruited approximately 30,000 volunteer bone marrow donors from the National Marrow Donor Program to respond to periodic questions via a smartphone app or website. Because HLA variations can determine appropriate matches between donors and recipients, the database includes information about their HLA types.
Each week, respondents were asked to report if they had been tested for SARS-CoV-2. Each day, they were asked to report whether they had symptoms associated with COVID-19. “We were pretty stringent in our definition of asymptomatic,” Hollenbach told NBC News. “[The respondents couldn’t] even have a scratchy throat.”
The researchers eventually identified a cohort of 1,428 people who had tested positive for SARS-CoV-2 between February 2020 and April 30, 2021, before vaccines were widely available. Among these individuals, 136 reported no symptoms for two weeks before or two weeks after a positive test.
“Overall, one in five individuals (20%) who remained asymptomatic after infection carried HLA-B*15:01, compared to 9% among patients reporting symptoms,” the researchers wrote in their medRxiv preprint. Study participants with two copies of the gene were more than eight times more likely to be asymptomatic.
The UCSF researchers also looked at four other HLA variants and found none to be “significantly associated” with lack of symptoms. They confirmed their findings by reproducing the HLA-B association in two additional independent cohorts, one from an earlier study in the UK and the other consisting of San Francisco-area residents.
Individuals in the latter group had either tested positive for SARS-CoV-2 or reported COVID symptoms, and their DNA was analyzed to determine their HLA types.
Pre-existing T-Cell Immunity May Reduce Severity of COVID-19 Infection
The UCSF researchers also attempted to determine how HLA-B*15:01 plays a role in knocking out SARS-CoV-2 infections. They noted previous research that indicated previous exposure to seasonal coronaviruses, such as common cold viruses, could limit the severity of COVID-19. The scientists hypothesized that pre-existing T-cell immunity in HLA-B carriers may be the key.
The COVID-19 HLA and Immunogenetics Consortium website describes how HLA and T-cells work together to ward off disease. HLA “proteins are found on the surface of all cells except red-blood cells.” They’re “like windows into the inner workings of a cell,” and T-cells use the molecules to determine the presence of foreign proteins that are likely signs of infection. “Activated T-cells can kill infected cells, or activate B-cells, which produce antibodies in response to an infection,” the website explains.
Hollenbach’s research team analyzed T-cells from pre-pandemic individuals and observed that in more than half of HLA-B carriers, the T-cells were reactive to a SARS-CoV-2 peptide. The scientists corroborated the hypothesis by examining crystal structures of the HLA-B*15:01 molecule in the presence of coronavirus spike peptides from SARS-CoV-2 and two other human coronaviruses: OC43-CoV and HKU1-CoV.
“Altogether, our results strongly support the hypothesis that HLA-B*15:01 mediates asymptomatic COVID-19 disease via pre-existing T-cell immunity due to previous exposure to HKU1-CoV and OC43-CoV,” the researchers wrote.
Can Genes Prevent COVID-19 Infections?
Meanwhile, researchers at The Rockefeller University in New York City are attempting to go further and see if there are mutations that prevent people from getting infected in the first place. NPR reported that they were seeking participants for a study seeking to identify so-called “superdodger” genes.
Study participants identified as possibly having superdodger genes receive a kit designed to collect saliva samples, after which the researchers sequence the respondents’ genomes. “We hope that in a group of 2,000 to 4,000 people, some people will have genetic mutations that tell us why they’re resistant to infection,” Casanova told NPR.
All this genetic research is in very early stages. But results are promising and may lead to new precision medicine clinical laboratory tests for identifying people who are predisposed to having an asymptomatic response to COVID-19 infection. That in turn could help scientists learn how to moderate or even eliminate symptoms in those unfortunate people who suffer the typical symptoms of the disease.
New lawsuit contends that the promissory notes Holmes allegedly issued on behalf of defunct clinical laboratory company Theranos are now overdue
Just weeks before Elizabeth Holmes is scheduled to begin her prison term for conviction in the federal investor fraud case related to now-defunct clinical laboratory company Theranos, the long-running legal saga of the former company founder/CEO continues to bring new twists.
This time, news emerged via a lawsuit that Holmes allegedly owes $25 million to Theranos creditors. CNBC obtained a copy of the suit and detailed its contents in a March 17 case update.
Theranos ABC, a company set up on behalf of the creditors, alleged in the lawsuit that “Holmes has not made any payments on account of any of the promissory notes,” CNBC reported. The suit was filed in Superior Court of California Count of Santa Clara.
Elizabeth Holmes (above), founder and former CEO of clinical laboratory company Theranos with husband Billy Evans of Evans Hotels. Holmes lives with Evans and the couple’s two children in the area near San Jose, California. Holmes gave birth to her second baby in February, according to People. In January, Holmes was convicted on three counts of wire fraud and one count of conspiracy. In addition to restitution, Holmes has been ordered to spend up to 11 years and three months in prison. (Photo copyright: Axios.)
Holmes Allegedly Issued Three Promissory Notes
The complaint stated that Holmes allegedly executed the following three promissory notes while she was still CEO at Theranos:
August 2011 in the amount of $9,159,333.65.
December 2011 in the amount of $7,578,575.52.
December 2013 in the amount of $9,129,991.10.
A promissory note is a written promise to pay a party a certain sum of money with a specified due date for the repayment of principal and interest.
“Theranos ABC has demanded payment of promissory note one and promissory note two from Holmes, but Holmes has failed to pay any amounts on account of promissory note,” according to the lawsuit, CNBC reported. The first two notes are overdue, and the third note is due in December.
Elizabeth Holmes’ Prison Term Could Be Delayed
News of the lawsuit, which was filed in December 2022, came to light at a court hearing on March 17. During that hearing, Judge Edward Davila heard arguments about whether Holmes should remain free pending her appeal. She is otherwise scheduled to report to prison on April 27 to begin her sentence after being convicted in January 2022 of defrauding Theranos investors.
Davila, who oversaw Holmes’ criminal case, is expected to issue a decision about her freedom during the appeal early this month. The judge is also weighing options for Holmes to pay restitution to her victims.
Prosecutors have asked that she pay back $878 million to Theranos’ former investors and other victims, according to court records reviewed by Dark Daily. The government has argued in court papers that Holmes continues to live a wealthy lifestyle despite her claiming she has no meaningful assets since the collapse of Theranos and her trial.
“Defendant has lived on an estate for over a year where, based upon the monthly cash flow statement defendant provided to the US Probation Office, monthly expenses exceed $13,000 per month,” according to court documents filed by prosecutors ahead of the March 17 hearing. “Defendant asserted that her partner pays the monthly bills rather than her but also listed her significant other’s salary as ‘$0.’”
Holmes’ attorneys argued that the government cannot take an “all or nothing” approach to restitution, and that payments should only be made to investors who testified during the trial, the Associated Press reported.
For Victims, Full Restitution Can Be Rare
The federal Department of Justice (DOJ) acknowledges in its overview of restitution that victims often never collect what they are owed by guilty parties.
“The chance of full recovery is very low,” the DOJ notes. “Many defendants will not have sufficient assets to repay their victims. Many defendants owe very large amounts of restitution to a large number of victims. In federal cases, restitution in the hundreds of thousands or millions of dollars is not unusual. While defendants may make partial payments toward the full restitution owed, it is rare that defendants are able to fully pay the entire restitution amount owed.”
Clinical laboratory professionals will note the irony that one of the biggest convicted fraudsters in US history is now largely attempting to avoid punishments associated with her crimes. If Judge Davila agrees to let Holmes remain free pending her appeal, she could stay out of prison for years and perhaps not have to pay restitution for that length of time as well.
The coming weeks will prove to be pivotal in the final outcome of the case.
Expect there to be more clinical laboratory testing at pharmacies as retail pharmacy chains expand their primary care offerings
Walgreens Boots Alliance (NASDAQ:WBA) of Deerfield, Illinois, continues to expand its primary care footprint with VillageMD’s latest acquisition of Starling Physicians, a multi-specialty physicians group with 30 locations in Connecticut, according to a VillageMD news release. Walgreens is the majority owner of VillageMD, which now has more than 700 medical centers, Healthcare Dive noted.
This deal continues the trend of corporations acquiring physician practices. Already, the majority of physicians are employees, not partners in a private practice physician group. Under corporate ownership, these physician groups often decide to change their clinical laboratory providers. For that reason, managers and pathologists at local medical laboratories will want to explore how they might provide daily lab testing services to the corporate owners of these primary care clinics.
The Hartford Business Journal called VillageMD’s acquisition of Starling Physicians—which is subject to a state investigation for possible certificate-of-need requirement—one of Connecticut’s “more high-profile healthcare merger and acquisition deals in Connecticut in recent years.”
The Starling Physicians group acquisition comes just a few months after
VillageMD paid $8.9 billion for Summit Health-CityMD of Berkeley Heights, New Jersey, with primary care services in the Northeast and Oregon. Walgreens invested $3.5 billion in that transaction, a Summit Health news release noted.
These acquisitions by Walgreens/VillageMD provide opportunities for local clinical laboratories to serve the physicians in these practices, though the operations may have a different patient flow and work process than traditional family practice clinics located in medical offices around community hospitals.
“Starling shares our vision of being a physician-led model and they provide care in a compassionate and exceptional way to all the patients they serve. By integrating primary care with specialty care, we are able to optimize access to high-quality care for our patients,” said Tim Barry (above), CEO and Chair of VillageMD in the news release. “This is a natural extension of our growth in the Northeast, including our recent acquisition of Summit Health-CityMD. Together, we are transforming the way healthcare is delivered in the United States.” Clinical laboratories in these areas will want to develop a strategy for serving the physicians practicing at these non-traditional locations. (Photo copyright: The Business Journals.)
Primary Care at Retail Locations a Growing Trend
Dark Daily and its sister publication The Dark Report have reported extensively on the growing trend by pharmacy chains and other retail superstores to add primary care services to their footprint.
In “By 2027, Walgreens Wants 1,000 Primary Care Clinics,” The Dark Report covered how Walgreens had disclosed that it would spend $5.2 billion to acquire a 63% interest to become the majority owner of VillageMD. Fierce Healthcare reported that “[Walgreens] planned to open at least 600 Village Medical at Walgreens primary-care practices across the country by 2025 and 1,000 by 2027.”
VillageMD is a primary care provider with same-day appointments, telehealth virtual visits, in-home care, and clinical laboratory diagnostic testing such as blood tests and urinalysis. Many VillageMD practices are located in buildings next door to Walgreens sites throughout the United States. (Photo copyright: Walgreens.)
Other Retailers Investing in Primary Care
Other retailers have recently taken deeper dives into healthcare as well.
According to Forbes, “The acquisition comes amid a flurry of acquisitions across the US for doctor practices, which are being purchased at an unprecedented pace by large retailers like Walgreens Boots Alliance, CVS Health, Amazon, and Walmart. Meanwhile, medical care providers owned by health insurers like UnitedHealth Group’s Optum and Cigna’s Evernorth are also in the doctor practice bidding war.”
And in February, CVS announced plans to acquire for $10.6 billion Oak Street Health, a Chicago-based primary care company with 169 medical centers across 21 states that plans to have more than 300 centers by 2026.
Do Clinical Laboratories Want Retail Customers?
The question of whether clinical laboratories should pursue retail customers is at this point academic. Consumer demand is driving the change and labs that don’t keep up may be left behind.
“The trend of putting full-service primary care clinics in retail pharmacies is a significant development for the clinical laboratory industry,” wrote Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “These clinics will need clinical lab tests and can be expected to shift patients away from traditional medical clinic sites for two reasons—lower price and convenience—since this new generation of primary care clinics will be located around the corner from where people live and work.”
Thus, healthcare system laboratories or large reference labs may want to reach out to Walgreens, CVS, Amazon, and Walmart for test referrals. These and other large retailers are investing heavily in the belief that consumers will continue to seek convenience in their healthcare.
