Triage Plus Price Set To Lift Pacific Edge's Economics
When finalized, the CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance. This will be subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD). Private health insurance companies make separate coverage and pricing decisions based on their own medical policy and contracting for a test.
In the Gapfill process CMS asks each MAC to propose prices for any new testing services based on estimates of the resources needed to develop and run the test, then recommends the median of those prices as its final price. The seven MACs responsible for processing Medicare claims across various jurisdictions in the United States have published their draft pricing for Triage Plus. While Novitas priced Triage Plus at US$1,587.69, due to its agreements with multiple MACs, the price provided by MolDX3 is the de facto median price, because MolDX pricing is used in 28 of the 50 states. The draft pricing for MolDX was US$1,018.44, and subject to public comments that are due by 28 June 2025, and some possible adjustment based on those comments, CMS is expected to make that price effective on 1 January 2026.
Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput4. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline.
Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon as the analytical validation (AV) and clinical validation (CV) studies have been published. The AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE study5, has already been submitted for publication.
Pacific Edge Chief Executive Dr Peter Meintjes said: 'We are very pleased that both MolDX and Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of US$1,018.44 and US$1,587.69 respectively. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk.
'The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics6 are used in our existing budget impact model7 we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most.'
Notes:
1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.
2 Cxbladder Triage Plus has CPT Code 0420U and has not yet completed the administrative name change from Cxbladder Detect+.
3 MolDX is a coverage and reimbursement program run by the Palmetto MAC that provides unique test registrations and technical assessments for molecular diagnostics products to which other MACs can subscribe. The majority of MACs have elected to do so, but Novitas and National Government Services do not.
4 Half year to 30 September 2024.
5 Detection and Risk stratification In Veterans presenting with hematuria: Savage S.J., et al (2025) The Prognostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting.
6 Lotan Y, Raman JD, Konety B, Daneshmand S, Schroeck F, Shariat SF, Black P, de Lange M, Asroff S, Goldfischer E, Efros M, Chong KT, Huang E, Chua HL, Wu QH, Yeow S, Lau W, Yong J, Eng M. Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. J Urol. 2022 Dec 30:101097 JU0000000000003126.
7 Tyson MD, Abouassaly R, Durant A, Smith AB, Seemann K, Shoskes DA. Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Pract. 2024 Jan;11(1):54-60. doi: 10.1097/UPJ.0000000000000489. Epub 2023 Nov 1. PMID: 37914255.
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NZ Herald
7 days ago
- NZ Herald
Embryo screening start-up Orchid Health raises ethical questions
Orchid, Siddiqui said in a tweet, is ushering in 'a generation that gets to be genetically blessed and avoid disease'. Right now, at US$2500 per embryo-screening on top of the average US$20,000 for a single cycle of IVF, Siddiqui's social network in Silicon Valley and other tech hubs is an ideal target market. These are the data-obsessed biohackers who buy smart rings and consume boutique services like annual full-body MRIs. They are comfortable with a brave new world of probabilistic, data-driven medical decision-making, and can afford the extra costs to give their children a genetic edge. Siddiqui, who intends to have four children using her own Orchid-screened embryos, advocates a bolder idea gaining ground in the tech world: that increasingly available and sophisticated fertility technologies will supplant sex as a preferred method of reproduction for everyone. SO INCREDIBLY PROUD to share 2 HUGE updates: 1) The first baby was born using @OrchidInc technology — and he's super cute 🥰 2) I tested my own embryos with Orchid — we got SO much information & l feel confident now 🚀 This is the future of how babies will be born! — Noor Siddiqui (@noor_siddiqui_) April 22, 2024 'Sex is for fun, and embryo screening is for babies,' Siddiqui said in a video she shared on X. Soon, she suggests, it will be unremarkable for hopeful couples to choose their embryos by spreadsheet, as her current clients do, weighing, say, a propensity for heart disease that is 1.7 times the risk of the general population against a 2.7 score for schizophrenia. Zilis, the mother of four of Musk's at least 14 children, has been an Orchid client, according to two people close to the company, speaking on the condition of anonymity to describe private conversations. They said at least one of Musk and Zilis' offspring is an Orchid baby. Siddiqui declined to comment on that assertion, which was first reported by the Information, a tech industry news site, last summer. Musk and Zilis did not respond to requests for comment. Orchid represents a slice of a broader cultural movement in which powerful people in Washington and Silicon Valley are pushing the importance of producing offspring. Vice-President JD Vance, Musk and Siddiqui's early benefactor, the conservative billionaire investor Peter Thiel, have all repeatedly argued that falling birthrates threaten the future of industrialised nations and that people should have more children to counteract the decline – a viewpoint known as pronatalism. Julie Kang and Roshan George of San Francisco had Orchid undertake polygenic screening of 12 of their embryos; their baby, Astra Meridian, was born this spring. Photo / The Washington Post, Camille Cohen This growing movement, which is far from a monolith and has fierce debates within it, is giving a huge boost to a fertility industry already experiencing heightened demand. In February, the Trump White House issued an executive order pushing for expanded access to IVF. And while the loudest voices arguing that people should have more babies are on the right, there's broader political support for increasing access to fertility treatments: a new California law, set to go into effect next July, mandates that all large insurers cover IVF and other fertility services. In Silicon Valley, innovations that could make these services more affordable and accessible are coming, some of them backed by people concerned with population decline. Thiel has funded the egg-freezing robotics start-up TMRW, launched a US$200 million fund to bring fertility services to Asia and bankrolled a family planning app connected to a right-wing magazine. The investor, who is gay, has recently become a father to four children through IVF and surrogacy, according to people familiar with his family choices, who spoke on the condition of anonymity to describe personal relationships. Thiel declined, through a spokesperson, to comment. Siddiqui, who has already created 16 of her own embryos and plans to do more IVF rounds, says her company has an important role to play in advancing people's ability to have more children. She told the Post that being able to have a healthy child should be considered a basic human right, and she has hosted a podcast episode on Fighting the Fertility Crisis, a discussion about the causes of population decline. The extensive genetic screening Orchid provides, she said, can help more people have babies – by improving the IVF success rate and allaying parents' fears about future babies' health risks. 'I think everyone who wants to have a baby should be able to have one,' she said, adding that IVF and genetic testing should be made available and affordable for everyone. But Orchid doesn't just help people have children; it helps them shape their future children in dramatically new ways. And that has sparked controversy. Some critics see its polygenic scoring as veering towards a contemporary form of eugenics, enabling a world in which the rich leap even further ahead with super intelligence and superior health starting from birth. Orchid founder Noor Siddiqui says "everyone who wants to have a baby should be able to have one". Photo / Washington Post Musk, who has funded a population research institute at the University of Texas, wants to produce offspring with genes for superior intelligence, Zilis told one of Musk's biographers. The two people close to the company said Siddiqui has provided intelligence screenings in the past to couples on an ad hoc basis – including, one of them said, to Zilis and Musk. Orchid declined to comment on that and vociferously rejected any association with eugenics. Siddiqui said Orchid helps prospective parents who would otherwise fear having children because of potential genetic disorders. IVF was controversial when it began in the 1970s, she said; protesters showed up with 'pitchforks' at the offices of the scientists pioneering the breakthrough and tried 'to put them in jail' for playing God. If they had prevailed, she added, '12 million people wouldn't exist today'. Orchid screens for intellectual disability but does not provide intelligence predictions, Siddiqui said. A growing number of start-ups do, however. One of them is the Thiel-funded start-up Nucleus; another is Heliospect Genomics, the research arm of Herasight, an executive of which is a bioethicist who advocates 'liberal eugenics' – casting that term as applying not to governmental efforts to weed out undesirable births but instead to parents' use of emerging biological tools to enhance their children's prospects. Until last month, Orchid's website featured advice from that bioethicist, Jonathan Anomaly, on overcoming scepticism about its service. 'We intentionally alter our environments, breed crops so that they're more nutritious and easier to harvest, and we've invented lightning rods and vaccines to make us less likely to die from natural disasters,' he wrote. 'I find the playing God objection a bit tiresome.' Orchid removed the page after the Post asked about it. Anomaly said he now prefers the term 'genetic enhancement' to 'eugenics'. Delian Asparouhov, a partner at Thiel's Founders Fund who has invested in Nucleus, made a similar argument. 'When you choose your married partner, you're using a form of eugenics,' he said. 'When your kids are older, you invest in tutors and great schools. What's the harm in using a tool that allows you to amplify that type of effect?' 'Russian roulette' or a jet to the future? In the United States, there are virtually no restrictions on the types of genetic predictions companies can offer, and no external vetting of their proprietary scoring methods. Orchid and a handful of other start-ups offering polygenic risk scores are barrelling forward in this largely unregulated milieu. The first Orchid baby was born in late 2023, and Orchid is now in 100 IVF clinics in the US – more than twice as many as a year ago. (The company won't say how many babies have been born using its service.) Nucleus launched its screenings, which test embryos for more than 900 heritable traits and conditions, last month. Yet several genetic scientists told the Post they doubt Orchid's core claim: that it can accurately sequence an entire human genome from just five cells collected from an early-stage embryo, enabling it to see many more single- and multiple-gene-derived disorders than other methods have. Experts have struggled to extract accurate genetic information from small embryonic samples, said Svetlana Yatsenko, a Stanford University pathology professor who specialises in clinical and research genetics. Genetic tests that use saliva or blood samples typically collect hundreds of thousands of cells. For its vastly smaller samples, Orchid uses a process called amplification, which creates copies of the DNA retrieved from the embryo. That process, Yatsenko said, can introduce major inaccuracies. 'You're making many, many mistakes in the amplification,' she said, rendering it problematic to declare any embryo free of a particular disease, or positive for one. 'It's basically Russian roulette.' George Church, a genomic sequencing pioneer at Harvard University and an Orchid investor, harbours no such doubts. Questioning the advancement that enables Orchid to sequence the full genome from such a small sample – enabling long-term health predictions and near-term defect detections in an embryo – is 'like asking how much faster is a jet than walking,' Church said. Relying on a small number of cells is not the technology's only shortcoming, other experts said. Numerous fertility doctors and scientists also told the Post they have serious reservations about screening embryos through polygenic risk scoring, the technique that allows Orchid and other companies to predict future disease by tying clusters of hundreds or even thousands of genes to disease outcomes and in some cases to other traits, such as intelligence and height. The vast majority of diseases that afflict humans are associated with many different genes rather than a single gene. These algorithmic scoring methods are increasingly accepted by scientific and medical experts because they have shown promise in predicting the occurrence in a general population of a growing number of common ailments, including coronary artery disease, type 2 diabetes, inflammatory bowel disease and breast cancer. Researchers and clinicians hope that such complex genetic predictions will come to significantly enhance the quality of medical care. But the genetic code reflects only propensities: much is still unknown about how constellations of genes and gene variants interact with an individual's environment and with one another to contribute to the likelihood of any individual getting a disease in life. And for traits such as intelligence, polygenic scoring has almost negligible predictive capacity – just a handful of IQ points. Critics say such scoring could compel couples who have struggled with fertility issues to discard perfectly good and hard-won embryos based on inaccurate or incomplete information. A 2024 paper raised concerns that the scores could encourage couples to unnecessarily incur the cost and physical burden of additional rounds of IVF. Or parents might select against an unwanted trait, such as schizophrenia, without understanding how they may be screening out desired traits associated with the same genes, such as creativity. 'Maybe we don't want to screen those people out of our society,' said Lior Pachter, a computational biologist specialising in genomics at the California Institute of Technology. Embryos are tested for viability in IVF labs. Photo / Getty Images In response to questions from The Post, an Orchid spokeswoman, Tara Harandi-Zadeh, said the company explicitly counsels patients not to throw away embryos. Company executives also downplayed the value of Orchid's polygenic scores, which one described in an interview as merely an 'add-on' benefit of the full-genome sequencing the company provides. The primary benefit of its service, she said, is the ability to detect many more single-gene-derived diseases and non-hereditary mutations than a standard genetic test conducted in an IVF clinic. 'Hundreds of serious monogenic diseases – each with well-established genetic causes – can now be detected before implantation,' Harandi-Zadeh said in a statement. 'These aren't vague risks or statistical associations; they're clear, causal mutations that lead to profound outcomes: seizures, organ failure, inability to walk or speak, early death. These are missed without comprehensive whole genome embryo screening.' Orchid's marketing materials and Siddiqui's own descriptions have repeatedly showcased polygenic disease screening, however. 'The parents and their physician get much more information' from polygenic scoring, Siddiqui said in a 2023 video. 'They get information about neurodevelopmental disorders, birth defects, pediatric hereditary cancers, complex conditions, meaning conditions where it's not just a single gene, but dozens, hundreds, to millions of genes that contribute risk.' Three-month-old Astra Meridian plays at home with her parents, Julie Kang and Roshan George, who used Orchid for a full genome screening of 12 embryos and selected one that didn't have a hearing-loss gene they both carried. Photo / The Washington Post, Camille Cohen The American College of Medical Genetics and Genomics calls the benefits of screening embryos for polygenic risks 'unproven' and warns that such tests 'should not be offered' by clinicians. A pioneer of polygenic risk scores, Harvard epidemiology professor Peter Kraft, has criticised Orchid, saying on X that 'the science doesn't add up' and that 'waving a magic wand and changing some of these variants at birth may not do anything at all'. Still, many of those same experts say the scientific evidence supporting the validity of polygenic scoring methods is only getting better and already making its way into clinical use for adults. Consumer attitudes are liable to change, too. Asparouhov, the investor, said he was still critical of embryo selection based on polygenic scores. 'Right now it's a false choice,' he said. 'But in the future, it's the trust fund.' 'A license to do things' The availability and power of consumer genetic tests have exploded in the past six to 10 years, powered by far cheaper human genome sequencing and large public and private biobanks that store genetic data from hundreds of thousands of volunteers. Researchers have used that data to explore connections between genes and population-wide disease outcomes, in what are known as genome-wide association studies, or GWAS. An influential 2018 paper in the peer-reviewed journal Nature Genetics showed that groups of genes could be analysed to identify people at significantly increased risk for five common ailments, including coronary artery disease, type 2 diabetes and breast cancer. That paper and others opened up the possibility for clinicians to give people specific medical advice and treatments based on their genetic propensity. Siddiqui founded Orchid the following year. She had moved to Silicon Valley from Northern Virginia after winning, in 2012, a $100,000 grant from Thiel for aspiring entrepreneurs willing to ditch college to pursue a business idea. Forgoing a university education was anathema to her Pakistani immigrant parents, she has said, so she applied in secret as a high school senior. Siddiqui's parents eventually came around, and she credits her mother with being the impetus for Orchid. When Siddiqui was a child, her mother developed retinitis pigmentosa, an eye disease caused by a rare genetic mutation. Siddiqui became acutely aware that some people were 'genetically privileged' – while others were not, like her mum, who was functionally blind. 'For people who haven't had that type of tragedy hit them or their family, it's really hard for them to relate,' she said. In a later stint at Stanford, where she completed degrees in computer science, Siddiqui became fascinated by the way data science was transforming biology, creating new potential applications for reproduction. She also became steeped in a close-knit milieu of self-described builders who looked up to Thiel. Her husband is a cybersecurity entrepreneur she met while a Thiel fellow; a friend, Laura Deming, who was in Siddiqui's Thiel Fellowship class, has been working on age-reversing technologies since she was a teenager. One of Siddiqui's early investors, billionaire Brian Armstrong, the right-leaning CEO of the cryptocurrency exchange Coinbase, said he invested after seeing a tweet about a class she was teaching at Stanford, called 'Frontiers of Reproductive Technology'. He has tweeted that preimplantation genetic testing is part of a 'Gattaca stack' – a reference to a 1997 dystopian science fiction film – of emerging innovations that will 'accelerate civilisational progress'. Had she not come to Silicon Valley at an early age, Siddiqui said, she would never have had the confidence to start a company. 'Everyone here took me incredibly seriously as a 17-, 18-year-old, working on medical start-ups,' she said in an interview next to San Francisco's Ferry Building. 'It's just a place where everyone has a licence to do things.' Noor Siddiqui at 18 in her home in Clifton, Virginia, in 2012, after she won a Thiel Fellowship enabling her to pursue a project of her own design before going to college. Photo / The Washington Post, Ricky Carioti Securing early funding from Armstrong, ethereum founder Vitalik Buterin, bitcoin and genetics entrepreneur Balaji Srinivasan, 23&me founder Anne Wojcicki, and others, Siddiqui got to work combing through scientific literature to build the company's proprietary polygenic scoring methods. In 2022, Orchid had what it describes as its big breakthrough: an innovation that enabled it to sequence all 3 billion base pairs of the human genome from as few as five embryonic cells. But the paper laying out that breakthrough, published last year in the peer-reviewed journal F&S Reports, is fundamentally flawed, according to Stanford's Yatsenko and Aleks Rajkovic, chief genomics officer at the University of California at San Francisco Health Center for Clinical Genetics and Genomics. It excluded results that didn't fit its thesis, Yatsenko said, and both scientists said that by using Orchid's own lab to check those results, its authors didn't adhere to ideal scientific practice. Orchid said that the paper's findings had been verified by independent labs and that there were 'zero discrepancies' in the results. Todd Lencz, the leader of a federally funded research project examining polygenic embryo screening, said the science isn't clear enough for use in a clinic. Subtle differences among different companies' algorithms 'can produce strikingly different results in clinical contexts,' said Lencz, a professor at Hofstra University's Zucker School of Medicine. 'There's no gold-standard consensus about which method is best.' Orchid countered that slight differences in algorithms' results are no argument for preventing people from benefiting from the best scientific knowledge available. Another big issue facing Orchid and other start-ups is that polygenic scores can be up to half as accurate, according to some researchers, for some people with non-European ancestry. The primary pools of genetic data available to researchers come from European and American sources, especially the UK Biobank, a large database in the United Kingdom that includes the genetic data of a half-million people. Siddiqui told The Post that Orchid is well aware of the potential for bias, noting that she is South Asian and her husband has Middle Eastern ancestry. She said the company uses standard statistical methods to correct for limitations in the scores. In some circumstances, she said, Orchid does not offer any score. The data used to create risk scores draws on the genetics of people who are now adults and often elderly, and it's unclear how much the risks faced by people now in their 70s apply to babies being born today, said Patrick Turley, a statistical-genetics researcher at the University of Southern California. Environmental factors that affect the genes of present-day embryos in-vitro, such as microplastics and endocrine-disrupting chemicals, are different from environmental factors many years ago, he added. And lifestyle and behaviour, which also impact genes and life outcomes, are different today than for generations past. 'It's hard to make projections about how well [polygenic scores] are going to predict in the future when the world's a different place,' Turley said, while emphasising that genetic embryo selection could benefit certain couples, such as those who are carriers of rare diseases. Orchid said research has shown that genetic predispositions are 'remarkably stable' across decades. 'Genetic signal doesn't vanish just because the world changes,' spokeswoman Harandi-Zadeh said. Pachter, the Caltech computational biologist, has called Orchid's offerings 'amoral nonsense' and said conveying genetic information in numerical scores gives a certain 'class of people' the illusion of more control than they really have, and validates the feeling that 'one's own genome must be special'. Orchid rejected Pachter's criticism, too. 'It's easy to moralise from an ivory tower when your child isn't the one who might be born with a fatal disease,' Harandi-Zadeh said. 'This isn't about 'some illusion of control.' It's about giving families the ability to prevent real suffering based on the most accurate information modern science can provide.' Seeking 'peace of mind' Roshan George, a start-up executive in San Francisco, said that when he and his wife, Julie Kang, used Orchid last year, the company's genetic counsellors gave detailed explanations about the probabilities of different predictions, emphasising that 'nothing is 100 percent certain'. The couple sought out Orchid after learning, during a standard parental genetic screening process at their IVF clinic, that both were carriers of a rare genetic mutation that causes irreversible hearing loss soon after the child is born. Julie Kang and Roshan George with their 3-month-old baby, Astra Meridian, in their home in San Francisco in late May. Photo / The Washington Post, Camille Cohen The couple's main concern was whether they were passing the hearing loss variant on to their embryo. Though they probably could have found out by screening the embryos at an IVF clinic through standard processes, which amplify a snippet of the genome, George sought out full genome screening for 'a more complete picture' and 'peace of mind,' he said. George and Kang produced 12 embryos and used Orchid to screen all of them – a cost of $30,000 on top of IVF. Six were viable. Two had the hearing loss gene variant. Another two were carriers, which meant they could pass the gene on to their children but wouldn't be affected themselves. And two, called embryos JK3 and 6-JK in Orchid's report, were unaffected. The couple pored over their spreadsheets, debating which of the two to select. One embryo had a 1.5% lifetime risk of bipolar disorder, about half that of the general population. But its type 2 diabetes risk – 29% – was slightly above average, about 1.2 times that of a typical person. Another had a slightly higher risk of obesity. Given his and Kang's ethnicities – South and East Asian, respectively – George took the predictions with 'a grain of salt'. After weighing all the other factors, the polygenic scoring became 'the tiebreaker,' George said. Kang gave birth in March; so far, their daughter, Astra Meridian, has perfect hearing. Julie Kang and Roshan George play with their baby in their home in San Francisco. Photo / The Washington Post, Camille Cohen The family's experience is likely to be a window into the future, scientists said, in which an abundance of data offers families improved odds for healthy children and fraught reproductive choices. If families seek that information, the medical industry shouldn't be 'paternalistic' and deny them, UCSF's Rajkovic said, but companies have to be careful not to promise more certainty than science can deliver. Orchid's offerings are 'not ready for prime time,' according to Rajkovic. But the premise the company is pursuing – better odds for healthy babies – is 'commendable in terms of pushing the barriers,' he said. 'Because genetic disease can be devastating.' Nitasha Tiku contributed to this report.
RNZ News
21-07-2025
- RNZ News
Is there confusion over the role of 'physician associates'?
An investigation ordered by the UK government into physician associates there has found they shouldn't diagnose and treat untriaged patients. It also recommends changing their name to "assistant" rather than associate to stop them being confused with doctors. Four months ago the Health Minister, Simeon Brown, gave the go ahead for Physician Associates to become part of the regulated health workforce here. At the moment the PA's working here are trained in the UK or the US and work under the licence of a supervising doctor. The New Zealand Resident Doctors' Association has backed the two main findings of the UK report, but the New Zealand Physicians Associate Society says the situation in the UK isn't applicable here. Kathryn is joined by Deborah Powell the National Secretary of the Resident Doctors Association and Lisa deWolfe the regulation chair of the New Zealand Physician Associate Society. To embed this content on your own webpage, cut and paste the following: See terms of use.
RNZ News
18-07-2025
- RNZ News
Trump diagnosed with chronic venous insufficiency following leg swelling
By Betsy Klein , CNN US President Donald Trump has been diagnosed with chronic venous insufficiency. File photo. Photo: Andrew Caballero-Reynolds / AFP US President Donald Trump was examined for swelling in his legs and has been diagnosed with chronic venous insufficiency, the White House announced Thursday. Trump, 79, underwent a "comprehensive examination, including diagnostic vascular studies" with the White House Medical Unit, press secretary Karoline Leavitt said, reading a note from the president's physician, Capt Sean Barbabella. Barbabella's letter, which was later released by the White House, states that "bilateral lower extremity venous Doppler ultrasounds were performed and revealed chronic venous insufficiency, a benign and common condition, particularly in individuals over the age of 70." The examination came after Trump had "noted mild swelling in his lower legs" over recent weeks, Leavitt said. "Importantly, there was no evidence of deep vein thrombosis (DVT) or arterial disease", and Trump's lab testing was all "within normal limits," according to the letter. Trump also underwent an echocardiogram. "No signs of heart failure, renal impairment, or systemic illness were identified," Barbabella wrote. Chronic venous insufficiency is a condition in which valves inside certain veins don't work the way they should, which can allow blood to pool or collect in the veins. About 150,000 people are diagnosed with it each year, and the risk goes up with age. Symptoms can include swelling in the lower legs or ankles, aching or cramping in the legs, varicose veins, and pain or skin changes. Treatment may involve medication or, in later stages, medical procedures. A woman wears Donald Trump leggings on 19 January 2025 in Washington, DC. Photo: Christopher Furlong / Getty Images / AFP "It's basically not alarming information, and it's not surprising," Dr Jeremy Faust, an assistant professor of emergency medicine at Harvard Medical School, told CNN. "This is a pretty normal part of aging, and especially for someone in the overweight to obese category, which is where the president has always been. "But the bigger concern … is that symptoms like this do need to be evaluated for more serious conditions, and that is what happened." Chronic venous insufficiency can be related to conditions like increased pressure from the heart or sleep apnea, cardiologist Dr Bernard Ashby told CNN. "Even though he's diagnosed with a benign condition, venous insufficiency, by itself, doesn't necessarily mean it's benign. The question is, what's causing the venous insufficiency? "And so I would want to know whether or not he has any evidence of, again, increased pressures in the heart or increased pressures in the lungs, which can be contributing to that, and if so, what is the primary cause of that?" Trump's doctors were "covering all their bases" by screening him for heart failure, increased pressure and other conditions, he said. Age, obesity and inactivity can all lead to the condition. "If a person is older, a person is overweight, a person is not engaging in regular physical activity or exercise, if a person is sitting or standing for prolonged amounts of time, you can get chronic venous insufficiency," Dr Chris Pernell told CNN. "And while it is not life-threatening, it can be debilitating," she added. Leavitt later added that the president was experiencing "no discomfort." The press secretary also addressed bruising that has appeared on the back of the president's hand, which she attributed to his "frequent handshaking," plus his use of aspirin. "This is consistent with minor soft tissue irritation from frequent handshaking and the use of aspirin, which is taken as part of a standard cardiovascular prevention regimen," Barbabella's letter said. The letter concludes that "President Trump remains in excellent health." Trump will become the nation's oldest president during his second term. -CNN
