This new sensor technology is thin enough to sit directly on a kidney's fibrous layer — called the renal capsule — which surrounds and protects the organ. The device works by continuously monitoring changes to blood flow and temperature. The built-in thermometer can sense increases as minuscule as 0.004 degrees Celsius. Once an irregularity is detected, the sensor, which contains a micro coin cell battery for power, uses Bluetooth to alert a patient or physician via a smartphone or tablet. Any increase typically signals inflammation which is a potential sign of transplant rejection.

After any surgery that involves an organ transplant, the risk of rejection is high. The sensor was developed specifically for kidney transplants but it could also work for other organs, including the liver and lungs. Kidney transplants in the US are on the rise and are usually recommended for people who will not be able to live without dialysis. The American Kidney Fund cites that an acute rejection of a kidney transplant one month after surgery happens in about five to twenty percent of patients that go under.

That’s why it is critical to detect transplant rejection, which occurs when your body's immune system treats the new organ like a foreign object and attacks it. If a healthcare provider detects signs of rejection early enough, medical intervention can preserve the new organ in the new host. Northwestern researchers said that the device detected warning signs of organ rejection three weeks earlier than current monitoring methods. The current “gold standard” for detecting rejection is a biopsy, where a tissue sample is extracted from the transplanted organ and then analyzed in a lab. However, biopsies are invasive and can cause bleeding and increase the risk for infection.

Despite developing an innovative first-of-its-kind product, researchers at Northwestern University still have a long way to go. It still needs to be tested on humans in a clinical setting before it can make any impact in the surgical market. Northwestern’s John A. Rogers, a bioelectronics expert who led the device development, said in a statement that his team is now evaluating ways to recharge the coin cell battery so that it can last a lifetime.

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During development, researchers from Brigham and Women’s Hospital designed the device specifically to help test treatments in patients with brain cancers or gliomas, a type of tumor that originates in the brain or spinal cord. The device is designed to only remain implanted in a patient for about two to three hours while it delivers microdoses of the respective drug that is under observation. It can observe the impact of up to 20 drugs on the market for cancerous tumors, according to the researchers. Once the device is removed (sometime before the surgery ends), the surrounding tissue is returned to the lab for analysis.

In a statement published Wednesday, Pierpaolo Peruzzi, co-principal investigator and assistant professor in the Department of Neurosurgery at Brigham and Women’s Hospital said that knowing the impact of cancer drugs on these tumors is critical. “We need to be able to understand, early on, which drug works best for any given patient,” he said.

During the development process, researchers at the Brigham and Women’s Hospital ran a clinical trial to observe the actual impact of the implant on real patients. The study found that none of the patients in the trial experienced any adverse effects. The researchers were able to collect biological data from the devices, such as what molecular changes happened when each drug was administered. While the study demonstrated that the implant could be easily incorporated into surgical practice, the researchers are still determining how the data it can gather should be used to optimize tumor therapy.

The researchers are now conducting another study that focuses on implanting the device through a minimally invasive procedure 72 hours before their main surgery. Advancements in the cancer treatment space continue to expand, with new iterations of drug cocktails and viruses that can fight cancer cells emerging in the biotech space. Implants like the one developed by the Brigham and Women’s Hospital bring scientists one step closer to better being able to use tools and data to provide more personalized care treatment plans for cancer patients.

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PCSK9 was lowered by as much as 84 percent in the cohorts that received higher infusion rates of the treatment. At those higher treatment doses, Verve scientists said that the reduction of those LDL-C-related proteins lasted 2.5 years in previous studies on primates.

From a clinical standpoint, this gene editing therapy has the potential to disrupt the current standard treatment for high cholesterol. The current go-to’s include prescription statins and PCSK9 inhibitors, but they require strict adherence and can have bad side effects like muscle pain and memory loss.

CRISPR, while seemingly miraculous, is a long way from replacing daily medications though. According to Nature, two of the 10 participants in the study suffered from a “cardiovascular event” that coincided with the infusion. Verve says one was not related to the treatment at all and the second was “potentially related to treatment due to proximity to dosing.” The use of a gene-editing technology will always carry some risk because the edits could occur elsewhere in the genome.

Before a single infusion therapy for high cholesterol can reach consumers, the FDA mandates that the treatment will need to be studied for up to 15 years. Verve recently received FDA clearance for an Investigational New Drug Application for VERVE-101, meaning that the company can begin to conduct trials in the US. The current trials in New Zealand and the United Kingdom will look for willing clinical trial participants to expand the study.

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Conventionally, sleep studies require patients to be hooked up to a number of sensors and devices. In labs and in at-home studies, sensors can be attached to a patient’s scalp, temples, chest and lungs with wires. A patient may also wear a nasal cannula, chest belt and pulse oximeter which can connect to a portable monitor. “As you can imagine, trying to sleep with all of this machinery can be challenging,” Traverso told Engadget.

This trial, which used a capsule made by Celero Systems —A start-up led by MIT and Harvard researchers— marks the first time ingestible sensor technology was tested in humans. Aside from the start-up and MIT, the research was spearheaded by experts at West Virginia University and other hospital affiliates.

The capsule contains two small batteries and a wireless antenna that transmits data. The ingestible sensor, which is the size of a vitamin capsule, traveled through the gastrointestinal tract, and collected signals from the device while it was in the stomach. The participants stayed at a sleep lab overnight while the device recorded respiration, heart rate, temperature and gastric motility. The sensor was also able to detect sleep apnea in one of the patients during the trial. The findings suggest that the ingestible was able to measure health metrics on par with medical-grade diagnostic equipment at the sleep center. Traditionally, patients that need to get diagnosed with specific sleep disorders are required to stay overnight at a sleep lab, where they get hooked onto an array of sensors and devices. Ingestible sensor technology eliminates the need for that.

Importantly, MIT says there were no adverse effects reported due to capsule ingestion. The capsule typically passes through a patient within a day or so, though that short internal shelf life may also limit how effective it could be as a monitoring device. Traverso told Engadget that he aims to have Celetro, which he co-founded, eventually contain a mechanism that will allow the capsule to sit in a patient’s stomach for a week.

Dr. Ali Rezai, the executive chair of the West Virginia University Rockefeller Neuroscience Institute, said that there is a huge potential for creating a new pathway through this device that will help providers identify when a patient is overdosing according to their vitals. In the future, researchers even anticipate that devices could incorporate drugs internally: overdose reversal agents, such as nalmefene, could be slowly administered if a sensor records that a person’s breathing rate slowed or stopped. More data from the studies will be made available in the coming months.

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Casgevy, which also received the greenlight from regulators in the UK for another blood disorder called beta thalassemia, works by being administered in a single-infusion of genetically modified stem cells to a patient. Clinical study participants that took Casgevy were free from symptoms associated with sickle cell disease, like periodic episodes of extreme pain due to blocked blood flow through vessels, for up to a year.

CRISPR, which modifies precise regions of a human’s DNA strands, was once thought to be a far off scientific innovation. Human cells were first modified using CRISPR in clinical trials in China back in 2016. Less than a decade later, these landmark approvals have set the stage for future nods by regulators for other CRISPR-based therapies that can treat things like HIV, cancers and high blood pressure. “Gene therapy holds the promise of delivering more targeted and effective treatments,” Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research said in a recent press release.

CRISPR-based gene editing can be designed as a therapeutic for a number of diseases. A scientist can either delete, disrupt or insert segments of DNA to treat conditions by either targeting specific genes or engineering new cell therapies. The editing process can occur ex vivo (outside the body), in the same way Casgevy does, or in vivo (inside the body). Using CRISPR, sickle cell patients’ blood stem cells are modified in a lab before they are re-infused via a single-dose infusion as part of a hematopoietic transplant.

Neville Sanjana, a core faculty member at the New York Genome Center and associate professor in the Department of Biology at New York University, runs the Sanjana lab, which develops gene therapies for complex diseases like autism and cancer. “One of the really fundamental characteristics of CRISPR is its programmability,” Sanjana told Engadget. While working at the Zhang lab at the Broad Institute of MIT and Harvard, Sanjana says he helped design the “guide RNA” that became the blueprint for Vertex’s Casgevy. “CRISPR screens can be powerful tools for understanding any disease or genetic trait,” Sanjana said. Right now, he said biomedical folks are focused on applying CRISPR-based therapies for really serious inheritable diseases.

While it does “set a precedent” to have these first CRISPR-based gene therapies out there, it could also mean that regulators and the general public will regard future innovations in the space as “less novel,” Katie Hasson, a researcher with the Center for Genetics and Society (CGS) told Engadget. The CGS is a public interest and social justice organization that is focused on making sure gene editing is developed and distributed for good. Hasson explained, it doesn’t mean that because one got approved that all other innovative therapies to come after it will not get as much scrutiny.

Beyond therapeutics, gene editing has very broad applications for the discovery and understanding of diseases. Scientists can use CRISPR to explore the origins of things like cancer and pave paths for therapeutics and incurable diagnoses, but that’s not all there is to it. Scientists still need to conduct “considerable experimental research” when it comes to bringing an actual therapeutic to fruition, Sanjana said. “When we focus on therapeutic activity at a particular site in the genome, we need to make sure that there will not be any unintended consequences in other parts of the genome.”

Still, the spotlight will always shine a brighter light on the flashy developments of CRISPR from a therapeutic standpoint. Currently, a new gene editing method is being developed to target specific cells in a process called “cancer shredding“ for difficult-to-treat brain cancer. Scientists have even discovered a pathway to engineer bacteria to discover tumorous cells. However, there are barriers to using CRISPR in clinical practice due to the lack of “safe delivery systems to target the tissues and cells.”

“Maybe by curing one disease, you might give them a different disease — especially if you think of cancer. We call that a secondary malignancy,” Sanjana said. While there is strong reason for concern, one cure creating a pathway for other diseases or cancers is not unique to CRISPR. For example, CAR T cell therapy, which uses an entirely different approach to cell-based gene therapy and is not reflective of CRISPR, is a lifesaving cancer treatment that the FDA discovered can, in certain situations, cause cancer.

“We definitely don’t want any unintended consequences. There are bits of the genome that if you edit them by mistake, it’s probably no big deal but then there are other genes that are vitally important,” Sanjana said. Direct assessment of “off-target effects” or events in which a gene edit incorrectly edits another point on a DNA strand in vivo is challenging.

The FDA recommends that after a clinical trials’ period of investigatory study looking at the efficacy of a gene editing-based therapy, there needs to be a 15-year long term follow up after product administration. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that the agency’s approval of Casgevy follows “rigorous evaluations of the scientific and clinical data.” Right now, researchers are focused on improving the precision and accuracy of gene editing and having the proper follow up is absolutely well merited, Sanjana explained. “The process right now is a careful one.”

Hasson believes that the 15-year recommendation is a good start. “I know that there is a big problem overall with pharmaceutical companies actually following through and doing those long term post-market studies.”

That’s where new approaches come into play. Base editing, a CRISPR-derived genome editing method that makes targeted changes to DNA sequences, has been around since 2016. Drugs that use base editing have already made headway in the scientific community. Verve Therapeutics developed a gene edited therapy that can lower cholesterol in patients with a single infusion. At higher doses, Verve said the treatment has the potential to reduce proteins associated with bad cholesterol for 2.5 years. Base editing, like CRISPR, has many potential applications for treatment and discovery. For example, base editing could repair a gene mutation that causes childhood blindness. Researchers at Weill Cornell Medicine also found base editing could help understand what genetic changes influence a patient’s response to cancer therapies.

Base editors use CRISPR to bring another functional element to a specific place in the genome. “But it doesn’t matter whether it’s CRISPR cutting or base editing… any time you’re modifying DNA…you would want to know what the off target effects are and you can bet that the FDA wants to know that too. You’re going to need to collect data using standard models like cell culture, or animal models to show there are zero or near zero off-target impacts,” Sanjana said.

CRISPR-based therapies already show high therapeutic potential for conditions beyond sickle cell disease. From blood based treatments, to edited allogeneic immune cells for cancers, there are a number of human clinical trials underway or expected to start next year. Trials for gene-edited therapies that target certain cells for cancer and autoimmune diseases are expected to begin in 2024.

It won’t be until 2025 before we get a better understanding of how Excision BioTherapeutics’ CRISPR-based therapy works to treat HIV. The application of gene editing as a therapeutic for Alzhiemer’s is still in the early stages, with mice at the forefront of research. Similarly, University College London researchers proved that CRISPR has promise as a potential therapeutic for treatment-resistant forms of childhood epilepsy. In a recent study, a gene edited therapy developed in the lab was shown to reduce seizures in mice.

But the clinical process of getting CRISPR to safely and effectively work as it’s intended isn’t the only hurdle. The pricing of CRISPR and related therapies in general will be a huge barrier to access. The Innovative Genomics Institute (IGI), a research group that hopes to advance ethical use of these gene editing in medicine, estimates that the average CRISPR-based therapy can cost between $500,000 and $2 million per patient. The IGI has built out an “Affordability Task Force” to tackle the issue of expanding access to these novel therapies. Vertex’s sickle cell treatment costs a cool $2.2 million per treatment, before hospital costs. David Altshuler, the chief scientific officer at Vertex, told MIT Tech Review that wants to innovate the delivery of the therapeutic and make it more accessible to patients. “I think the goal will be achieved sooner by finding another modality, like a pill that can be distributed much more effectively,” Altshuler said.

“Access is a huge issue and it’s a huge equity issue,” the CGS’ Hasson told Engadget. “I think we would also like to look at equity here even more broadly. It’s not just about who gets access to the medication once it comes on the market but really how can we prioritize equity in the research that’s leading to these treatments.” The US already does a poor job of providing equitable healthcare access as it is, Hasson explained, which is why it’s important for organizations like CGS to pose roundtable discussions about implementing guardrails that value ethical considerations. “If you support people having access to healthcare, it should encompass these cutting edge treatments as well.”

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The call to challenge the status quo was controversial from the start — it not only was going to impact thousands of studies and experiments, but many scientists argued that computer models were nowhere near ready to replace animals as test subjects. In a letter written by a group of public health officials, the experts urged the EPA’s head Michael Regan to reconsider the ban because computational models, in their opinion, were “not yet developed to the point” where they could be relied on for risk assessments.

In order for the new ban to have taken effect, the EPA said there needed to be “scientific confidence” that non-animal models could soundly replace critters like mice and rabbits in labs. Despite the 2035 deadline being put on ice, however, an EPA spokesperson told Science that it would still explore alternatives to animal testing.

The ambitious plan is not entirely a lost cause, though. While the EPA hasn’t made any official statements about how it plans to work toward its original goal, now without a deadline, some studies have shown promise that computational models might effectively reflect the toxicology of certain chemicals during testing. In some instances, these studies suggest, they can even outperform lab rats.

3D developments like technical organoids are also popping up on the research front by way of stem cells that allow duped livers to be tested and evaluated during research as a human liver would. Labs are currently working on ways to more effectively develop realistic organs using 3D printers. But it might be a while before 3D printing can consistently be used to assist biologists and pharmacologists for research and drug testing.

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The current standard PDAC screening criteria catches about 10 percent of cases in patients examined by professionals. In comparison, MIT’s PRISM was able to identify PDAC cases 35 percent of the time.

While using AI in the field of diagnostics is not an entirely new feat, MIT’s PRISM stands out because of how it was developed. The neural network was programmed based on access to diverse sets of real electronic health records from health institutions across the US. It was fed the data of over 5 million patient’s electronic health records, which researchers from the team said “surpassed the scale” of information fed to an AI model in this particular area of research. “The model uses routine clinical and lab data to make its predictions, and the diversity of the US population is a significant advancement over other PDAC models, which are usually confined to specific geographic regions like a few healthcare centers in the US,” Kai Jia, MIT CSAIL PhD senior author of the paper said.

MIT’s PRISM project started over six years ago. The motivation behind developing an algorithm that can detect PDAC early has a lot to do with the fact that most patients get diagnosed in the later stages of the cancer’s development — specifically about eighty percent are diagnosed far too late.

The AI works by analyzing patient demographics, previous diagnoses, current and previous medications in care plans and lab results. Collectively, the model works to predict the probability of cancer by analyzing electronic health record data in tandem with things like a patient’s age and certain risk factors evident in their lifestyle. Still, PRISM is still only able to help diagnose as many patients at the rate the AI can reach the masses. At the moment, the technology is bound to MIT labs and select patients in the US. The logistical challenge of scaling the AI will involve feeding the algorithm more diverse data sets and perhaps even global health profiles to increase accessibility.

Nonetheless, this isn't MIT’s first stab at developing an AI model that can predict cancer risk. It notably developed a way to train models how to predict the risk of breast cancer among women using mammogram records. In that line of research, MIT experts confirmed, the more diverse the data sets, the better the AI gets at diagnosing cancers across diverse races and populations. The continued development of AI models that can predict cancer probability will not only improve outcomes for patients if malignancy is identified earlier, it will also lessen the workload of overworked medical professionals. The market for AI in diagnostics is so ripe for change that it is piquing the interest of big tech commercial companies like IBM, which attempted to create an AI program that can detect breast cancer a year in advance.

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One in two older women who have experienced menopause gets osteoporosis (the disease that comes after prolonged and untreated osteopenia), which is characterized by porous bones that can easily fracture. The Osteoboost belt is designed to prevent bone density from reaching that stage through early intervention. It works by mechanically stimulating the strength of the bones in the hips and spine of a wearer and prevents the further progression of bone density disintegration. The blueprint for the technology comes from NASA research that was investigating ways to prevent bone density from weakening in astronauts that work in mostly zero gravity environments where deterioration becomes a concern.

The belt should be worn for 30 minutes every day or at least five times a week for it to fully take effect. It delivers a gentle vibration that makes it easy to be worn pretty much anywhere or at any time, such as during dog walks or while washing dishes. During clinical trials, CT scans showed that following the integration of the belt into a patient’s care plan, bone density visually improved over time. In a study backed by the NIH, women aged 50 to 60 lost 3.4 percent of their bone density by the end of 12 months without any intervention, while patients who wore the belt lost only 0.5 percent of their bone strength.

Current standards of care for preventing osteoporosis during the osteopenia stage are mostly lifestyle suggestions that can be hard to adhere to, such as a well-balanced and calcium-rich diet, frequent weight-bearing exercises and reducing the risk of falls. “Although lifestyle interventions such as exercise and diet are beneficial to bone, the effect is small. The Osteoboost shows promise in slowing the loss of bone density and strength and may fill the treatment gap,” Laura Bilek, a researcher who has studied the belt’s effectiveness said.

Osteoboost is still not yet available for sale, but you can sign up to get notified when the device is released. A company representative said they will begin shipping later this year and will accept pre-orders in the next few months. While the price is also still not disclosed, the representative told Engadget that the belt will be “affordable and accessible to the millions of patients who need it.” To get the device, you will need a prescription from your doctor — so pricing may vary depending on insurers and co-pays. Bone Health Technology said it is currently in talks with insurers regarding coverage for the medical device. While the price projection could have drastically changed, three years ago the CEO Laura Yecies told NS Medical Devices she believed the device could debut for about $800.

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