Zhejiang University

GA, UNITED STATES, July 3, 2026 / EINPresswire.com / -- Biliary atresia (BA), a rare but serious liver disease in infants, can move quickly from subtle newborn signs to irreversible liver injury. Early treatment with Kasai portoenterostomy (KP) offers the best chance of delaying or avoiding liver transplantation, yet many infants are still diagnosed after the most favorable treatment window has passed. A newly described clinical strategy aims to shorten this delay by pairing two practical steps: direct or conjugated bilirubin (DB/Bc) measurements and a feeding abdominal ultrasound exam. Together, the approach could help clinicians identify infants who need urgent evaluation while reducing unnecessary invasive testing in those less likely to have BA. BA is difficult to detect because early jaundice can resemble common newborn conditions, and pale stools may not appear immediately. The disease is thought to begin before birth, when the extrahepatic bile ducts do not form properly. After birth, bile builds up in the liver, driving progressive injury and increasing the likelihood of liver transplantation. Studies have shown that infants treated before 30–45 days of life tend to have better long-term outcomes, but diagnosis is often delayed beyond 60 days. Due to these challenges, there is a need for deeper research into faster, simpler, and more equitable diagnostic workflows for early BA detection. Researchers from Texas Children's Hospital and Baylor College of Medicine, with collaborators from Stanford University School of Medicine, published a review on March 16, 2026, in World Journal of Pediatric Surgery. The article describes a streamlined pathway developed at a Texas pediatric center to accelerate BA diagnosis by combining DB/Bc testing, interpretation through BiliScreen.org, and a feeding ultrasound approach focused on key biliary imaging signs. The first step uses DB/Bc measurements in the newborn nursery and early outpatient visits. The review highlights evidence that DB/Bc levels can be elevated in the first 24–48 hours of life in infants with BA, before clear clinical signs or other liver injury markers emerge. Primary care providers (PCPs) are also guided to test DB/Bc levels at 2–4 weeks when infants have persistent jaundice, pale stools, or a previous high DB/Bc result, consistent with American Academy of Pediatrics (AAP) guidance. The second step is a feeding abdominal ultrasound exam for infants with high DB/Bc levels. Instead of requiring fasting, the infant feeds before or during imaging, which can make the duct at the hilum (DaH) easier to visualize. The exam also measures maximum echogenicity (MxE) near the right portal vein. In the proposed workflow, an MxE greater than 4.0 mm or an absent DaH raises concern for BA and may prompt definitive evaluation, while other findings may support continued outpatient assessment. The authors said the strategy is designed to make early BA evaluation more actionable for the full care team, from nursery providers and PCPs to radiologists, hepatologists, and surgeons. They said the aim is not to replace specialists' judgment, but to give clinicians clearer signals at the moment when time matters most. By sharing the pathway, they hope other centers will provide feedback, test the approach in different practice settings, and adapt useful parts into their own workflows. The potential implications are broad. Universal newborn DB/Bc screening could reduce delays and may also help address disparities in diagnosis by identifying risk before visual signs are missed or misread. The feeding ultrasound approach could make follow-up evaluation less burdensome by avoiding fasting and potentially reducing reliance on tests that require anesthesia or invasive procedures. For families, earlier detection could mean faster treatment decisions and a better chance of preserving the native liver. Future studies will need to evaluate implementation, cost-effectiveness, and performance across multiple centers and healthcare systems. References DOI 10.1136/wjps-2025-001142 Original Source URL https://doi-org.sutd.idm.oclc.org/10.1136/wjps-2025-001142 Funding information Work shared in this review was funded by the NIH National Institute of Diabetes and Digestive and Kidney Diseases (K23DK109207), the American Association for the Study of Liver Diseases, the American Liver Foundation, and Biliary Atresia Research and Education, Inc (BARE). The work is also supported through generous philanthropic contributions from families affected by biliary atresia and from Robert and Annie Graham. About World Journal of Pediatric Surgery World Journal of Pediatric Surgery (WJPS), founded in 2018, is the open-access, peer-reviewed journal in pediatric surgery area. Sponsored by Zhejiang University and Children's Hospital Zhejiang University School of Medicine, and published by BMJ Group. WJPS aims to be a leading international platform for advances in pediatric surgical research and practice. Indexed in PubMed, ESCI, Scopus, CAS, DOAJ, and CSCD, WJPS achieved the latest Impact Factor (IF) of 1.3/Q3 and an estimate 2025 IF of 2.0. Lucy Wang BioDesign Research email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

SHANGHAI, June 30, 2026 /PRNewswire/ -- Tsingke Biotech recently hosted the Oligonucleotide Drug Salon at the Hilton Shanghai Zhangjiang, bringing together experts from academia, biopharmaceutical companies, investment firms, and industry service organizations to discuss technological innovation, CMC development, delivery technologies, regulatory strategies, and commercialization pathways in the rapidly evolving field of oligonucleotide therapeutics. Continue Reading Industry experts, researchers, and biopharmaceutical professionals gather at the Tsingke Biotech Oligonucleotide Drug Salon in Shanghai to discuss the future of oligonucleotide therapeutics. As momentum in the global nucleic acid medicine sector continues to build, advances in chemistry, delivery systems, manufacturing, and clinical research are broadening the therapeutic applications of these modalities. The event provided a platform for stakeholders across the value chain to exchange perspectives on emerging trends and explore opportunities for collaboration and industry growth. Advancing Industry Collaboration Opening the event, Shijin Ma, CEO of Tsingke Biotech, noted that China's small nucleic acid industry is entering a new stage of development, evolving from technology adoption toward innovation-driven growth. "Open collaboration has become increasingly important as the industry advances," said Ma. "Progress in nucleic acid therapeutics depends on coordinated innovation across the value chain—from nucleic acid synthesis and delivery technologies to CMC development and regulatory advancement. Through this forum, we hope to encourage meaningful dialogue and strengthen connections across the industry." Expert Perspectives on Technology, Development, and Regulation The scientific program featured presentations covering key aspects of small nucleic acid drug development. Dr. Jun Bai, Head of the Nucleic Acid Research Department at Haichang Biotech, reviewed the evolution of siRNA therapeutics from sequence design and chemical modification to delivery platform development. He highlighted recent advances in GalNAc conjugates, antibody-oligonucleotide conjugates (AOCs), dual-targeting strategies, adipose tissue targeting, and kidney-directed delivery approaches. Professor Qixian Chen, Chief Scientist of Tsingke Biotech and Professor at the Yangtze River Delta Intelligent Green Innovation Center of Zhejiang University, shared research progress in nucleic acid delivery technologies. His presentation focused on approaches designed to overcome intracellular delivery barriers and improve delivery beyond the liver, including applications in central nervous system and tumor-targeted therapies. Providing a regulatory perspective, Dr. Yaning Wang, Founder and CEO of Shanghai Ruiningkang Bio , former Director of the Clinical Quantitative Pharmacology Review Division at the U.S. Food and Drug Administration (FDA), and Chief Scientific Advisor to Tsingke Biotech, analyzed representative FDA approval cases and discussed scientific evidence generation, surrogate endpoint selection, and key considerations in regulatory decision-making for nucleic acid therapeutics. Dr. Chengjiang Zhao, Co-founder of Youjia (Hangzhou) Biomedical Technology, examined critical CMC considerations from candidate selection through IND submission. Drawing on project experience, he highlighted the importance of strategic planning across process development, analytical methods, formulation development, quality studies, and toxicology batch manufacturing. Representing the host organization, Dr. Xichao Chen, Head of Small Nucleic Acid Technology at Tsingke Biotech, introduced the company's integrated oligonucleotide drug development platform, outlining capabilities spanning sequence design, modification optimization, process development, and CMC studies. Industry Leaders Discuss the Road Ahead The event concluded with a roundtable discussion that brought together perspectives from across scientific innovation, CMC development, regulatory review, capital markets, and industry collaboration. Participants agreed that as the sector continues to mature, long-term competitiveness will depend not only on individual technological breakthroughs, but also on the ability to integrate scientific innovation, manufacturing capabilities, regulatory expertise, and broader ecosystem resources. Supporting the Full Lifecycle of Small Nucleic Acid Drug Development As one of the early participants in China's nucleic acid industry, Tsingke Biotech has focused on building foundational technologies and industrial capabilities to advance nucleic acid-based therapeutics. Leveraging proprietary nucleic acid synthesis equipment, core raw material technologies, and integrated manufacturing platforms, the company provides services spanning both research-grade and GMP-grade production. These capabilities support programs from early discovery through process development and commercialization. Tsingke Biotech's service portfolio includes: Nucleic Acid Synthesis and Modification Platform: Customized development of siRNA, ASO, and other modified oligonucleotides, including 2'-OMe, 2'-F, phosphorothioate (PS), and GalNAc conjugation technologies. Small Nucleic Acid Drug CDMO Platform: Services covering hit screening, lead optimization, process development, analytical testing, and IND-enabling studies. Analytical Testing Platform: Quality research and analytical support for both development and regulatory submission. The company is also exploring the application of artificial intelligence in nucleic acid drug development, including sequence design, candidate screening, and process optimization, with the goal of improving efficiency and accelerating development timelines. Looking Ahead The global field of small nucleic acid therapeutics continues to expand, driven by progress in basic research, clinical development, and manufacturing technologies that are enabling wider adoption of this modality. Tsingke Biotech remains committed to collaborating with academic institutions, innovative biopharmaceutical companies, and industry partners to advance technological innovation and accelerate the development of new therapies for patients worldwide. About Tsingke Biotech Tsingke Biotech is a leading innovator in synthetic biology, with a mission to build "the world's great gene factory." Combining proprietary reagents, consumables, and synthesis equipment with AI-driven molecular manufacturing technologies, Tsingke Biotech provides efficient and high-quality gene synthesis services. Its work supports industries ranging from biopharma to agriculture, food, and environmental sciences. For news and updates, follow Tsingke Biotech on LinkedIn. Media contact: Mandy Qiu [email protected] +86-13470470511 21% more press release views with Request a Demo

On June 8, at the American Diabetes Association meeting, Adaptyx Biosciences put up data the field has chased for ten years and never produced: the first continuous, multi-day readings of free cortisol pulled from a sensor sitting in the fluid just under the skin. The Stanford spinout walked off with the 2026 ADA Innovation Challenge . Investors had already placed their bets. Level Zero Health is putting hormones on a microneedle patch for $6.9 million. London's Sava Technologies raised €16.6 million on a line that tells you exactly how this market is being pitched: "glucose is only the beginning." The promise is that cortisol will do for stress and sleep what continuous glucose monitoring did for diabetes. It skips the part that matters, which is that cortisol is a far nastier thing to measure than glucose, in almost every way that breaks a sensor. Why cortisol monitoring is one million times harder than glucose tracking Let's start with how much of it there is. Glucose floods the body, running in the millimolar range and barely thinning out between blood and the interstitial fluid a sensor sits in, which is why a glucometer can be slightly sloppy and still land right. Free cortisol, the fraction that actually crosses into cells and does anything, moves in the low nanomolar range , somewhere between ten thousand and a million times more dilute. If glucose is sugar you can taste in your coffee, free cortisol is a few grains of something dropped in a bathtub, and the sensor has to read it correctly while sitting in that bathtub. Glucose also came with a free gift. A cheap, durable enzyme, glucose oxidase, eats glucose and hands back an electrical signal, and it has been the engine inside every glucometer since 1967. Cortisol has no such enzyme. Nobody sells cortisol oxidase, and nobody will invent one for a patch. So instead of letting chemistry do the counting, a cortisol sensor has to physically catch the whole intact molecule and recognize its shape, and that is where the engineering gets expensive. Catching it is the part everyone can already do - a hospital ELISA grabs cortisol with an antibody and reads it cleanly and has for decades. The trouble is that those tests fire once, like a mousetrap. They bind the target, give one number, and the surface is spent. A device meant to follow cortisol across a night of sleep needs the opposite, something that grabs the molecule, reports it, lets it go, resets, and repeats that thousands of times over several days without anyone refilling a reagent. That reset is the whole problem, and where most of the real science of the last few years has gone. How DNA aptamer sensors solved the continuous cortisol problem The frontrunner solution is a strand of DNA. An electrochemical aptamer is a short piece of DNA anchored to a gold electrode and tipped with a marker that shuttles electrons, usually methylene blue. Cortisol lands on it, and the strand folds, swinging the marker toward the electrode so the current climbs. Cortisol drifts off, the strand relaxes, the current settles back. Nothing is consumed, so the same electrode answers over and over. Adaptyx calls its version a molecular switch, licensed from the Stanford labs of H. Tom Soh and Joseph DeSimone and built on a $14 million seed round last October, and it runs sixteen at once, eight reading cortisol against eight controls. Then the body fights back. Drop one of these electrodes into living tissue, and proteins start settling onto the gold within minutes, like grease creeping across a camera lens, and the baseline wanders ten to thirty percent in an hour until the signal is buried under the gunk. The repair that made continuous sensing usable came from Kevin Plaxco's lab : add a second marker at a different voltage that feels only the fouling, then subtract it out. Drift drops under 2%. It works, and it is worth being clear about what it is, a correction propping up a measurement that is not stable on its own. A second camp throws out the biology entirely. Molecularly imprinted polymers cast a hard synthetic cavity in the exact shape of cortisol, a lock with no key returned, which fouls less and lasts longer but is slow to reset. A Zhejiang University group built a sweat version in 2025 that hit a 0.36 nanomolar detection limit across eight reuse cycles, real numbers that arrive with a tax: it needs iontophoresis, a small current that pushes a drug into the skin to force sweat out, which means more electronics, more power, and more to break on the patch. Interstitial fluid vs. sweat: Which cortisol sensor approach will win? The fluid a company chooses decides its future. Adaptyx and Level Zero push microneedles through the skin into interstitial fluid, which shadows free blood cortisol closely and lands them squarely in regulated-device territory. The sweat crowd stays on top of the skin, noninvasive, easier to sell, and pays in noise. John Rogers's group at Northwestern published a genuinely clever design in Nature Sensors this year that turns paper test strips into time-stamped sweat readings and tracks serum at 0.94, but each zone fires once. Lined up, that is a string of snapshots, and calling it continuous is a stretch. Down at the consumer end, the language gets looser than the data. EnLiSense sells Corti, a passive-sweat cortisol and melatonin band, and to its credit, calls it a general wellness device with no FDA clearance, backed by an October study showing better than 0.92 agreement with saliva across 43 people. Clair Health , fresh off an $11.6 million round in June, does not measure a hormone at all. It infers cortisol from heart rate, skin temperature, and similar signals through a machine-learning model, the same move Oura uses to guess menstrual-cycle phase. That can be a perfectly good product. It is not cortisol sensing, and the gap stops being a technicality the instant anyone makes a medical claim. That medical claim is the entire ballgame, and FDA has already tipped its hand. A cortisol test is Class II under 21 CFR 862.1205 , but every cleared predicate is a bench immunoassay, so a continuous on-body device has nothing to call itself equivalent to and almost certainly enters through De Novo, the same door Dexcom's G6 used in 2018 to create the integrated-CGM category. FDA approval: The real barrier to continuous cortisol devices That route is the map worth copying, special controls and all, down to the over-the-counter clearances Stelo and Abbott's Lingo collected in 2024. What will not work is hiding behind the word wellness. Last July, FDA sent WHOOP a warning letter over a blood-pressure feature and threw out the wellness framing flatly, ruling that estimating someone's blood pressure cannot be walked back from diagnosing hypertension, whatever the marketing says. A band that murmurs about your stress has room to operate.  That warning letter was recently resolved. The moment it mentions Addison's disease, Cushing's, or when to take a hydrocortisone dose, it is a medical device and gets treated like one. Cushing's syndrome is less about a single high reading than a rhythm that has broken, the overnight low that should arrive and does not, which a one-shot saliva or urine test tends to miss, as a March 2026 review in JCEM spells out. People on hydrocortisone for Addison's or congenital adrenal hyperplasia are largely blind, and published pharmacology shows some of them sitting uncovered for nearly half a day while the labs their doctor orders come back normal. Intensive care is the same gap from the other side, where sepsis guidance tells clinicians not to trust a single spot cortisol in a critically ill patient, which is precisely the hole a continuous line could fill. So, the need is real, and the proof is not. Adaptyx says its readings showed concordance with mass-spec blood draws, and concordance is carrying a lot of unpaid weight there, because the company has not shown a correlation coefficient, a sample size, or a Bland-Altman plot behind it. Sweat sensors still agree with blood only loosely at rest, and worse the moment someone moves or panics. Not one continuous cortisol device holds any FDA clearance, which makes this pre-commercial, and the billion-dollar market figures already circulating are worth nothing until a product exists to pin them to. The only honest benchmark sitting next to it is CGM, a US market one, a 2025 report puts on track for $8.4 billion by 2033 , built over roughly twenty years on the backs of tens of millions of diabetic patients. Here is the part Adaptyx and the labs around it have earned- they cleared the one bar that demanded new science, proving a reusable sensor can track a hormone present at a few billionths of a mole through an ordinary day on a real body. That was the hard problem, and it is solved. Everything left is the unglamorous work that buries most device companies, the long haul from a sensor that works to a cleared product that a hospital will pay for. Cortisol may well become the next thing worth watching around the clock.