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Animal Healthcare Company Zoetis Completes Acquisition of Basepaws, a Company That Sells At-home DNA Testing Kits for Cats

Genetic testing for the health and wellbeing of beloved pets is not unlike clinical laboratory testing to develop personalized treatments for humans

Clinical laboratory professionals know that the same patients who complain about a $10 copay for their own laboratory testing will happily pay veterinarians tons of cash to test and treat their beloved pets. And as genetic testing for humans becomes commonplace, more people are seemingly willing to pay for genetic analyses of their pets as well.

In June, animal health company Zoetis, Inc. announced it had completed the acquisition of pet care genetics company Basepaws. The financial terms of the deal were not disclosed.

California-based Basepaws is a privately-held company that provides pet owners with analytics, genetic tests, and early health risk assessments for their pets through oral microbiome analysis. Founded in 2017, Basepaws was responsible for the creation of the first at-home genetic testing platform for cats.

Basepaws sells easy-to-use genetic testing kits for cats that allow pet owners and veterinarians to better understand an individual pet’s predisposition to certain illnesses and increase the likelihood of early detection and treatment of those diseases.

It’s not unlike the drive toward personalized medicine and genetic testing that is at the core of human precision medicine.

Different Breeds, Different Needs

Basepaws has a slogan: “Different breeds, different needs.” This means, according to their website, each individual cat has a unique composition of genetic traits that can relate to its needs for optimal health and wellbeing. Obviously, this would apply to all pets.

“As a pioneer in pet care genetics, the California-based Basepaws offers easy-to-use genetic screening tools for the early detection of disease risk in pets, as well as individualized breed and health reports that can identify traits, biomarkers, and potential hereditary conditions for pets. Basepaws helps pet owners and veterinarians understand an individual pet’s risk for disease and can lead to more meaningful engagements and increased likelihood of early detection and treatment of disease,” states a Zoetis press release announcing the acquisition.

“The addition of Basepaws will enhance our portfolio in the precision animal health space and inform our future pipeline of pet care innovations,” said Kristin Peck, CEO of Zoetis, in the press release. “Working together, we can continue to provide veterinarians and pet owners with more comprehensive ways to proactively manage the health, wellness, and quality of care for their animals.”

Anna Skaya
“Basepaws and Zoetis both consist of pet lovers with a passion for science, and our mission is to create better and longer lives for our pets through knowledge and data,” Anna Skaya (above), CEO of Basepaws, told ROI-N.J. “We look forward to expanding our business and the impact of our genetic products with the global scale and [research and development] experience of Zoetis, the world leader in animal health. We believe that, together, we can bring the benefits of a more proactive healthcare approach to pet parents around the world.” Genetic testing for optimum pet health is not unlike the drive for personalized clinical laboratory genetic testing for humans. (Photo copyright: Los Angeles Times.)

Test Results for Hundreds of Genetic Disorders and Health Markers

Basepaws currently sells three DNA test kits for felines on their webpage. The current price for an oral health test kit that identifies active signs of dental diseases is $69. Their breed and cat health DNA test kit, which provides results for over 115 known feline genetic markers, is $129. Their most comprehensive testing kit is a whole genome sequencing (WGS) kit which is currently on sale for $399.

After receiving a test kit by mail, the purchaser registers the kit online, takes a single buccal swab from their kitty’s inner cheek, and then mails the sample to Basepaws. Lab personnel then extract the cat’s DNA from the sample and perform quality checks to ensure the sample is acceptable for genetic testing. It takes four to six weeks for consumers to receive test results.

According to the company’s website, Basepaws’ WGS test provides results related to 43 genetic disorders that are represented by 65 health markers. The listing of genetic disorders contained in the Health Marker section of the Basepaws report includes data on:

  • Metabolic disorders,
  • Musculoskeletal and connective tissue disorders,
  • Renal disorders,
  • Cardiovascular disorders,
  • Blood disorders,
  • Eye disorders,
  • Endocrine disorders,
  • Skin disorders, and
  • Autoimmune disorders.

“The Basepaws team has done an amazing job demonstrating how genetic testing and data can improve how we care for the pets in our lives,” Abhay Nayak, Executive Vice President at Zoetis, told ROI-NJ. “With the addition of Basepaws, Zoetis will continue to strengthen our portfolio of products for precision animal health, across genetics, diagnostics, and data analytics for pets and livestock. We are also excited by how Basepaws’ feline genomic and microbiome database will help enhance our [research and development] capabilities and inform the future of our pet care pipeline.”

Zoetis, based in Parsippany, N.J., manufactures vaccines, medicines, clinical laboratory diagnostics, and other technologies for the benefit of companion pets and livestock. The Fortune 500 company generated $7.8 billion in revenue in 2021, according to its website.

American’s Spend Billions Caring for Their Pets

An article in the peer-reviewed journal PLOS One, titled, “Exploratory Content Analysis of Direct-to-Consumer Pet Genomics: What Is Being Marketed and What Are Consumers Saying?” noted that US pet owners spent approximately $103.6 billion on their pets in 2020, with 30% of that amount going towards veterinary care and products.

The article also stated that the global animal genetic testing market was valued at $990 million in 2020 and is only expected to rise.

Thus, spending money keeping our pets healthy is not only a typical element of Americans’ lives, but also a mega-billion-dollar industry. With at-home genetic testing for humans increasing in popularity, it’s likely testing for animals will follow that trend as well.

In the future, some clinical laboratory organizations may want to consider assessing the animal DNA testing market for its potential to be a useful source of new revenue, especially because potential customers will pay cash when they order genetic tests for their dogs and cats.  

JP Schlingman

Related Information:

Zoetis Acquiring Basepaws, Leader in Pet Care Genetics

Zoetis Completes Acquisition of Basepaws, an Innovative Leader in Petcare Genetics, to Strengthen its Portfolio of Precision Animal Health Solutions

Exploratory Content Analysis of Direct-to-consumer Pet Genomics: What is Being Marketed and What Are Consumers Saying?

UK Researchers Using Genetic Sequencing to Study Convergent Evolution Determine Molecular Data Superior to Morphology in Determining Evolutionary Relationships

Discovery calls into question accuracy of traditional methods for developing evolutionary trees of animals

Can a type of shrew be more related to an elephant than to other shrews? According to researchers at Milner Center for Evolution at the University of Bath (UB) in the United Kingdom, it’s possible, and their genetic study into convergent evolution may lead to improved use of genetic sequencing for the development of precision medicine treatments and clinical laboratory testing.

In fact, the UB study suggests traditional anatomical methods for determining the evolutionary relationships between species may not be as accurate as once thought, an article in SciTechDaily reported.

Nevertheless, the UB’s research into convergent evolution is unlocking new insights into how genes evolve over time and this new knowledge may help researchers develop genetic tests that more accurately identify different diseases and health conditions.

Additionally, studies that bring a better understanding of how beneficial genetic mutations work their way into a species’ genome might also aid researchers in developing personalized clinical laboratory testing and therapies based on manipulating a patient’s genetic sequences in ways that would be beneficial.

The UB researchers published their findings in the journal Nature Communications Biology, titled, “Molecular Phylogenies Map to Biogeography Better than Morphological Ones.”

Gene Sequencing More Accurate at Determining Evolutionary Relationships

The UB study suggests that existing evolutionary (phylogenetic) trees may need to be reconsidered. To put a finer point on the findings, a UB news release on the study states, “determining evolutionary trees of organisms by comparing anatomy rather than gene sequences is misleading.”

The UB scientists used genetic sequencing to quickly—and more cost effectively—determine evolutionary relationships as compared to traditional morphology (anatomy and structure), according to the news release.

They found genetic data that revealed surprising relationships about where the sequenced species originated, and which differed with prior conclusions that were drawn based on the species’ appearance. The findings suggest there may be need to “overturn centuries of scientific work in classifying relation of species by physical traits,” the UB scientists said.

Matthew Wills, PhD
“For over a hundred years, we’ve been classifying organisms according to how they look and are put together anatomically, but molecular data often tells us a rather different story,” said Matthew Wills, PhD (above), Professor of Evolutionary Paleobiology, Milner Center for Education at the University of Bath, in the news release. “Our study proves statistically that if you build an evolutionary tree of animals based on their molecular data, it often fits much better with their geographical distribution.” This new use of genetic sequencing could lead to improved precision medicine treatments and clinical laboratory testing. (Photo copyright: University of Bath.)

Molecular Data Leads to New Insights into Convergent Evolution

The UB study’s use of genetic sequencing led the researchers to a greater understanding of convergent evolution, defined by “a characteristic evolving separately in two genetically unrelated groups of organisms,” according to UB.

For example, wings are a widely developed characteristic. But they are not necessarily a sign of relatedness when it comes to birds, bats, and insects.

“Now with molecular data, we can see that convergent evolution happens all the time—things we thought were closely related often turn out to be far apart on the tree of life,” Wills said, adding, “Individuals within a family don’t always look similar; it’s the same with evolutionary trees, too.”

Family Trees: Morphology Versus Molecular

In their paper, the UB researchers acknowledged the importance of phylogenies (evolutionary history of species) in areas of biology, including medicine. They aimed to study a better way to produce accurate phylogenetic trees.

“Phylogenetic relationships are inferred principally from two classes of data: morphological and molecular,” they wrote, adding, “The superiority of molecular trees has rarely been assessed empirically.”

So, they set out to compare the two approaches to building evolutionary trees:

  • Traditional morphology analysis, and
  • Phylogenetic trees developed using molecular data.

Using 48 pairs of morphological and molecular trees, they mapped data geographically.

“We show that, on average, molecular trees provide a better fit to biogeographic data than their morphological counterparts, and that biogeographic congruence increases over research time,” the researchers wrote.

Biogeography a Better Gauge of Relatedness than Anatomy

The study also found animals on molecular trees lived geographically closer as compared to groups on morphological trees.

For example, molecular studies put aardvarks, elephants, golden moles, swimming manatees, and elephant shews in an Afrotheria group, named for Africa, which is where they came from. Therefore, the biogeography matches, however the appearances of these mammals clearly do not, the UB scientists point out.

“What’s most exciting is that we find strong statistical proof of molecular trees fitting better not just in groups like Afrotheria, but across the tree of life in birds, reptiles, insects, and plants,” said Jack Oyston PhD, UB Department of Biology and Biochemistry Research Associate and first author of the study, in the news release.

The researchers believe their findings support the accuracy of genetic-themed trees.

“It being such a widespread pattern makes it much more potentially useful as a general test of different evolutionary trees. But it also shows just how pervasive convergent evolution has been when it comes to misleading us,” Oyston added.

Advantages of Molecular Data

In their Nature Communications Biology paper, the UB scientists wrote that molecular data offer up these advantages over morphology:

  • Widely available in vast quantity.
  • Opportunity exists to “search, repurpose, and reanalyze sequenced data alongside novel sequences.”
  • Less subjectivity in researchers’ analysis.
  • Well-developed data at the ready and “still in their infancy.”

The University of Bath’s study of convergent evolution, phylogenetic trees, and comparison of molecular data versus morphology, has implications for medical laboratories. Should their research lead to new insights into how genes evolve over time, diagnostics professionals may have new information to identity diseases and work with others to precisely treat patients.

Donna Marie Pocius

Related Information:

Study Suggests That Most of Our Evolutionary Trees Could Be Wrong

Molecular Phylogenies Map to Biogeography Better than Morphological Ones

Convergent Evolution Has Been Fooling Us: Most of Our Evolutionary Trees Could Be Wrong

We May Have Family Trees All Wrong

Have We Got Evolutionary Trees All Wrong?

Two Georgia Hospitals First to Be Fined by CMS for Failure to Comply with Hospital Price Transparency Law

Nearly two years after passage of price transparency law, only a small number of the nation’s hospitals are fully compliant, according to two separate reports

Price transparency is a major trend in the US healthcare system. Yet, hospitals, physicians, clinical laboratories, and other providers have been reticent to design their websites so it is easy for patients to find prices in advance of clinical care. Now comes news that federal officials are ready to issue fines to hospitals that fail to comply with regulations mandating price transparency for patients. 

Many of the largest healthcare networks claim that complying with federal hospital price transparency regulation is costly, time consuming, and provides no return on investment. Nevertheless, the federal Centers for Medicare and Medicaid Services is quite serious about enforcing price transparency laws, and to that end the agency has, for the first time, levied fines against two hospitals in Georgia that have not complied with the regulations.

As many pathologists and medical laboratory managers know, on January 1, 2021, a federal rule on price transparency for medical facilities went into effect. The rule requires hospitals—as well as clinical laboratories and other healthcare providers—to post a comprehensive list of their services and the pricing for those services on their websites, and to provide access to a patient-friendly tool to help consumers shop for 300 common services.

The CMS recently issued its first penalties to two hospitals located in Georgia for violating the law by not updating their websites or replying to the agency’s warning letters. The letters CMS sent to the two hospitals alleged there were several violations of the transparency rules, including the failure to post a listing of their charges on their websites and requested corrective action plans by the hospitals.

In November 2021, Northside Hospital Atlanta informed regulators that consumers should call or email the facility to obtain price estimates for services. Later in January 2022, during a “technical assistance call,” a hospital representative told CMS “the previous violations had not been corrected and, in fact, the hospital system had intentionally removed all previously posted pricing files,” according to a Notice of Imposition of a Civil Monetary Penalty letter CMS sent to Robert Quattrocchi, President and Chief Executive Officer, Northside Hospital Atlanta.

Under the rules of the Hospital Price Transparency law, each hospital operating in the US is required to provide clear, accessible pricing information online about the items and services they provide in two ways:

  • As a comprehensive machine-readable file listing all items and services.
  • In a display of shoppable services in a consumer-friendly format.

CMS fined Northside Hospital Atlanta $883,180 and Northside Cherokee Hospital $214,320 for noncompliance with the law. The penalties are calculated based on the size of the hospital and the length of time of the noncompliance—up to $300 per day. In addition, the facilities could endure further monetary penalties if they continue to fail to comply. The organizations will have 30 days to appeal the charges or have 60 days to remit payment for the fines.

Both hospitals are owned by Northside, a Georgia health system with five acute care hospitals, more than 250 outpatient facilities, over 4,100 providers, and 25,500 employees, according to the provider’s website.

Meena Seshamani, MD, PhD
“CMS expects hospitals to comply with the Hospital Price Transparency regulations that require providing clear, accessible pricing information online about the items and services they provide,” said Meena Seshamani, MD, PhD, Director of CMS, in a statement provided to Fierce Healthcare. “This enforcement action affirms the Biden-Harris Administration’s commitment to making healthcare pricing information accessible to people across the country and we are committed to ensuring that consumers have the information they need to make fully informed decisions regarding their healthcare.” Clinical laboratories also are required to comply with federal price transparency regulations. (Photo copyright: Modern Healthcare.)

Compliance with Price Transparency Laws Low

Analysis of the healthcare industry shows that many facilities are not in compliance with the transparency rules. In April, a report released by health IT firm KLAS Research, found that hospitals believe the transparency rule is too costly to implement and confusing to consumers, which helps explain the low compliance issues. KLAS surveyed 66 hospital revenue cycle leaders for their report.

“There are concerns about cost, data accuracy, and patient options of pricing tools; some respondents worry about patients’ ability to understand the displayed pricing data, and today, most patients are unaware online pricing information exists,” the report states. In addition, the report notes that “many organizations are not investing beyond the bare minimum requirements, and they don’t plan to do more until there is further clarity around the regulations and the expectations going forward.”

The KLAS report also noted that organizations are struggling to find the resources to comply with the price transparency rule and consider it a financial burden to continually add new employees and technology to become and remain in compliance. Many organizations see no merit in investing in a regulation that provides no return on that investment.

Another compliance report released in February by Patient Rights Advocate maintained that only 14.3% of the 1,000 hospitals they reviewed were in full compliance with the Hospital Price Transparency regulation. About 37.9% of the hospitals posted a sufficient detailing of service rates, but over half of those hospitals were noncompliant in other criteria of the rule, such as rates by insurer and insurance plans.

“We are now entering the second year since the Hospital Price Transparency rule became law, and compliance remains at very low levels,” according to the report. “The largest hospital systems are effectively ignoring the law, with no consequences.”

The Patient Rights Advocate analysis also found that a mere 0.5% of hospitals owned by the three largest hospital systems in the country—HCA Healthcare, CommonSpirit Health, and Ascension—were in full compliance of the law.

Notably, only two of the 361 hospitals owned by these three hospital systems were fully compliant. In addition, none of the 188 hospitals owned by HCA Healthcare, the largest for-profit hospital system in the country, were in compliance.

Hospitals Fail to Provide Consumers with Critical Information

The Patient Rights Advocate report found that the most significant reason for noncompliance was failure to post all payer-specific and plan-specific negotiated rates on their websites. They estimated that 85.7% of the 1,000 hospitals reviewed did not post a complete machine-readable file of standard charges, as required by the law.

“The lack of compliance by hospitals is about more than simply the failure to follow the legal requirements,” the report states. “It is also about the failure of hospitals to provide critically needed information to consumers so they can make better health decisions. Empowered with comparative price and quality information in advance of care, consumers, including employers and unions, can improve health outcomes while lowering costs by taking advantage of the benefits of competitive market efficiencies.”

With the CMS starting to issue fines for noncompliance, it is probable that more healthcare organizations will focus on adhering to the Hospital Price Transparency law. Since the transparency rules also apply to clinical laboratories, lab managers should be aware of the regulations and any further enforcement actions taken by the CMS.   

JP Schlingman

Related Information:

Hospitals Face Penalties for First Time for Failing to Make Prices Public

CMS Issues First Price Transparency Fines to Two Georgia Hospitals

After Months of Warnings, CMS Hands Out Its First Fines to Hospitals Failing on Price Transparency

KLAS: Hospitals Say Price Transparency Remains Too Confusing and Pricey to Implement

Price Transparency 2022: Hospital Perceptions of CMS Regulation

Semi-Annual Hospital Price Transparency Compliance Report: February 2022

Report: Only 14.3% of Hospitals Compliant with Price Transparency Rules One Year In

Hospital Associations and Healthcare Groups Battle HHS Efforts to Expand Pricing Transparency Rules to Include Negotiated Rates with Payers

Health Insurers and Hospital Groups Argue Price Transparency Rules on Hospitals, Clinical Laboratories, and Other Providers Will Add Costs and ‘Confuse’ Consumers

Scientists in Italy Sequence DNA of Man Who Died in Mount Vesuvius Eruption at Pompeii in 79 AD

It’s the latest example of how genetic technologies have advanced to the point where DNA can be extracted and sequenced from human remains that are thousands of years old, often generating new insights that can benefit clinical laboratory testing

How might an individual in Pompeii who died in the famous Mount Vesuvius volcanic eruption of 79 AD help medical science today? The answer is that sequencing this individual’s DNA may yield insights into health conditions and infectious diseases of that era that could help scientists better understand disease today in ways that improve diagnosis and clinical laboratory testing.

Additionally, researchers studying genetic sequencing are discovering the technology has many more capabilities that previously thought. One such example involves scientists from the University of Copenhagen, the University of Salento, and victims of the eruption. This research team has determined that even severely damaged biological samples may contain viable DNA.

When Mount Vesuvius erupted, volcanic ash and pumice buried many residents of the town of Pompeii in southern Italy. The ash was estimated to have been about 500 degrees Fahrenheit, which should have been hot enough to cause significant damage to DNA. However, it appears the pyroclastic materials released during the eruption may instead have preserved some of the victims’ DNA.

“One of the main drivers of DNA degradation is oxygen (the other being water),” Gabriele Scorrano, PhD, Assistant Professor, University of Copenhagen and lead author of the study told CNN. “Temperature works more as a catalyst, speeding up the process. Therefore, if low oxygen is present, there is a limit of how much DNA degradation can take place.”

The scientists succeeded in performing completed genetic sequencing on one of the victims of the violent eruption. This has genetic researchers rethinking how DNA could be recovered from damaged biological materials.

The researchers published their findings in the journal Nature Scientific Reports, titled, “Bioarcheological and Paleogenomic Portrait of Two Pompeiians That Died During the Eruption of Vesuvius in 79 AD.”

Serena Viva, PhD

“In the future, many more genomes from Pompeii can be studied,” anthropologist Serena Viva, PhD (above), a postdoctoral researcher at the University of Salento in Italy and one of the authors of the study told the Guardian. “The victims of Pompeii experienced a natural catastrophe, a thermal shock, and it was not known that you could preserve their genetic material. This study provides this confirmation, and that new technology on genetic analysis allows us to sequence genomes also on damaged material.” What new clinical laboratory testing may come out of this study is not known. But it shows that there is still much to learn about genetic sequencing. (Photo copyright: University of Salento.)

Findings Suggest High Levels of Genetic Diversity

“There was the expectation that the high temperatures would make our effort in DNA sequencing in Pompeii fruitless,” Scorrano stated. “Cremated bodies, for example, show no sign of DNA preservation according to multiple studies.”

The scientists examined the skeletal remains of two victims found in a building known as Casa del Fabbro or House of the Craftsman to determine if any DNA was present. One skeleton was that of a man in his 30’s who was about five feet four inches in height and the other skeleton was of a woman who appeared to be at least 50 years of age and around five feet tall.

Although the researchers did obtain genetic material from both skeletons, they were only able to sequence the entire genome from the remains of the male skeleton.

The researchers compared his DNA with that of 1,030 other ancient and 471 modern western Eurasian people. The results suggest that the DNA from the male Pompeii skeleton shares the most similarities with people who currently live or lived in central Italy in the past.

Further analysis of the man’s DNA identified groups of genes that are commonly found in people from the island of Sardinia, but not in other people who lived in Italy during the Roman Imperial age. This suggested to the researchers that there may have been high levels of genetic diversity across Italy in 79 AD when Mount Vesuvius erupted.

Additional testing also identified sequences that are commonly found in a group of bacteria known to cause tuberculosis of the spine (Pott disease), a common ailment at that time. This implies the man had the illness when he perished.

Two skeletons fund in Pompeii's Casa del Fabbro

The photo above shows the two skeletons (one man and one woman) found in Pompeii’s Casa del Fabbro. Though the University scientists tried to extract full sequences from both skeletons, they only succeeded with the male. (Photo copyright: Notizie degli Scavi di Antichità, 1934, p. 286, fig. 10.)

First Pompeiian Genetic Sequence

Scientists had attempted to sequence DNA from Pompeiian victims before, but previous endeavors to analyze more than small DNA strands failed.

“To our knowledge, our results represent the first successfully sequenced Pompeiian human genome,” they wrote in Nature Scientific Reports. “Our initial findings provide a foundation to promote an intensive and extensive paleogenetic analysis in order to reconstruct the genetic history of population from Pompeii, a unique archaeological site.”

It is unclear how equivalent studies could fare in the future, but the researchers involved in this study hope to use their sequencing techniques on other remains. It is possible that DNA from this Roman man who died in Pompeii in 79 AD may be used to determine if he has any descendants living today.

Other Genetic Sequencing of Ancient Skeletons

In 1997, researchers from the Natural History Museum in London and Oxford University extracted mitochondrial DNA from a tooth of a skeleton from a Stone Age man known as “Cheddar Man.” That skeleton was found near a village called Cheddar in the Somerset region of southwest England.

After months of research and the charting of Cheddar Man’s DNA, the scientists visited a school in Cheddar to extract DNA samples from schoolchildren and look for DNA matches. About 20 samples were taken in total including one from a teacher named Adrian Targett.

“They wanted to take DNA samples from some of the students whose families had lived longest in the area,” Targett told the Los Angeles Times. “I gave a [cheek swab] sample too, just to encourage the children and to make up the numbers.”

Although none of the children were a genetic match to the Cheddar Man, Targett was identified as a direct descendant of the skeleton.

“It’s a bit frightening to think that there are all those links across all those generations,” Targett said. “But the nice thing is that there are links that are so strong. We are all descended from an ancestor like Cheddar Man. Who knows how many people we are related to and don’t know about?”

The Pompeii DNA research is the latest example of how the ongoing reduction in the cost, faster throughput, and increased accuracy of genetic sequencing is allowing scientists to gain new knowledge from ancient artifacts. In turn, some of these new insights may lead to improving how certain health conditions are diagnosed, possibly using novel clinical laboratory tests developed as a result of this research.

JP Schlingman

Related Information:

An Ancient Roman Who Died in Pompeii Has Had [His] Genome Sequenced

Scientists Fully Sequenced DNA of a Man Who Died at Pompeii and Found He May Have Had a Disease That Hindered His Escape

First Human Genome from Pompeii Sequenced

This Man Was Encased in Volcanic Ash in Pompeii. Here’s What His DNA Reveals

Bioarcheological and Paleogenomic Portrait of Two Pompeiians [Who] Died During the Eruption of Vesuvius in 79 AD

Pompeii Victim’s Genome Successfully Sequenced for First Time

‘He’s One of Us’: Modern Neighbors Welcome Cheddar Man

Briton Is Kin of Stone Age ‘Cheddar Man’

Supply Chain Shortages Threaten Medical Imaging Testing While Clinical Laboratories Face Scarcity of Blood Collection Specimen Tubes

From infant formula to contrast dye for CT scans, ongoing healthcare product shortages highlight continuing US supply chain and manufacturing issues

Medical laboratory directors and pathologists have firsthand knowledge of COVID-19 pandemic-driven supply chain issues, having faced backlogs for everything from pipettes and transport media to personal protective equipment (PPE). But the latest shortage impacting blood collection tubes is another example of why it is important to manufacture key products—including clinical laboratory tests, analyzers, and consumables—domestically.

On January 19, 2022, the federal Food and Drug Administration (FDA) issued a Letter to Healthcare Providers and Laboratory Personnel recommending “conservation strategies” to minimize blood collection tube use because of  “significant disruptions” in supplies due to COVID-19-increased demand and “recent vendor supply challenges.”

“The FDA updated the device shortage list to include all blood specimen collection tubes (product codes GIM and JKA),” the letter noted.

This announcement followed a similar June 10, 2021, Letter to Healthcare Providers and Laboratory Personnel that stated the FDA was aware “that the US is experiencing significant interruptions in the supply of sodium citrate blood specimen collection (light blue top) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges.”

A spokesperson for Becton-Dickinson (BD), a manufacturer of blood specimen collection products, told Forbes that the COVID-19 pandemic caused “the most unpredictable demand that BD has experienced in our company’s history.” The spokesperson added, “Worldwide, BD produced nearly a half a billion additional blood tubes in 2021 versus 2020 … Like every business across every industry around the world, BD is experiencing limited availability of and access to raw materials, shipping and transportation delays, and labor shortages, which hinders our ability to ramp production.”

Christine Nielsen, CEO of the Canadian Society for Medical Laboratory Science, explained that the supply-chain problem includes many routine items, such as Phosphate-buffered saline, and cannot be solved by stockpiling certain supplies.

“It’s also a challenge because we’ve moved to just-in-time (JIT) inventory across all sectors, including labs … They outdate just like food [and] are no longer fresh. [The product] is no longer reliable and you can’t use it. So, we can’t stockpile either,” Nielsen told Forbes.

Shortages Hit Other Critical Healthcare Sectors

But shortages of supplies and equipment have spread beyond the clinical laboratory. Intravenous contrast—which contains iodine and is used to improve the accuracy of CT scans and exclude life-threatening conditions such as cancer—has been in short supply since GE Healthcare shut down its manufacturing facility in Shanghai, China, during the city’s two-month pandemic lockdown that began in early April.

“I can’t overstate the importance of iodinated contrast for really critical diagnostic tests,” said radiologist Geoffrey Rubin, MD, a specialist in cardiovascular and pulmonary imaging, and professor and Chair of Radiology at University of Arizona, Tucson, in a Radiological Society of North America (RSNA) news release covering the contrast shortage.

“This isn’t an ancillary tool. This is something that’s used many, many times every day for both lifesaving decisions in the setting of trauma and for managing cancer patients and determining the appropriate care for them,” he added.

Rosa DeLauro, US Representative
 US Rep. Rosa DeLauro (above), lamented the fact these vital products are not being made in sufficient quantities in the US. “In the wealthiest nation on Earth, there should be no reason doctors are forced to ration lifesaving medical scans to compensate for a shortage of material,” DeLauro told The New York Times. “We are seeing supply chains break down because of consolidated industries experiencing manufacturing shortages and offshoring American jobs to China.” Clinical laboratory managers have first-hand knowledge of the severity of supply shortages. (Photo copyright: CNN.)

GE Healthcare is one of four companies that supply iodine-containing contrast to the United States, but the other three manufacturers have been unable to scale-up and offset the shortage.

By June 14, 2022, the Shanghai facility had returned to 100% production capacity following the easing of local COVID restrictions, according to a GE Healthcare statement. But shortages remain.

“There is still the challenge of bringing the contrast media across the ocean and distributing it to healthcare facilities across the nation,” Nancy Foster, the American Hospital Association’s (AHA) Vice President of Quality and Patient Safety Policy, told CNN.

“The hospital association estimates that about half of all hospitals in the United States rely on GE for contrast dye to perform about 20 million scans a year, or about 385,000 scans each week,” CNN reported.

Critical Medical Products Must be Manufactured Domestically

Oncologist Shikha Jain, MD, Assistant Professor of Medicine at the University of Illinois Cancer Center in Chicago, told CNN that contrast shortages are “not an isolated incident.”

“We’ve been having shortages throughout the pandemic. At the very beginning of the pandemic, it was PPE shortages,” Jain said. “Now, we have contrast shortages and formula shortages for babies.”

The infant formula crisis is the other headline grabbing news in recent weeks. Three companies—Abbott, Reckitt, and Gerber—manufacture 95% of the baby formula sold in the US, with Abbott controlling roughly 42% of the nation’s supply, CNN reported.

“Initially, this problem affected those who are on more specialized formulas or had nutritional issues,” Stephanie Seger, Director of Government Relations at Children’s Mercy Hospital in Kansas City, Mo., told CNN. ‘Then the gap, or the emptiness on the shelves, increased to the point where it’s now any formula. It’s now any parent of any baby.”

The Biden administration took steps in May to increase the supply of imported formula, but like the Intravenous contrast shortage, the problem has not been solved.

The COVID-19 pandemic has served to underscore the serious issues affecting supply chains for hospital, medical laboratory, and other critical supplies. While no quick fix has appeared on the horizon, the clinical laboratory industry should take steps now to work toward long-term solutions.

—Andrea Downing Peck

Related Information:

GE Healthcare Update on Iodinated Contrast Media

Update: Blood Specimen Collection Tube Conservation Strategies—Letter to Health Care and Laboratory Personnel

Blood Specimen Collection Tube Shortage: Frequently Asked Questions

Patients Face Long Delays for Imaging of Cancers and Other Diseases

Memorandum: Hearing on ‘Formula Safety and Supply: Protecting the Health of America’s Babies’

President Biden Announces Additional Steps to Address Infant Formula Shortage

Despite Moves to Increase Supply, Families Are Still Feeling the Pain of the Baby Formula Shortage

Blood Collection Tube Shortages Continue, ‘Routine’ Labs Should Be Limited

Hospitals Grapple with Shortage of Crucial Component for Medical Imaging Testing

Iodinated Contrast Shortage Challenges Radiologists

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