Sarepta says will continue to ship Elevidys to ambulant population
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Chicago Tribune
a day ago
- Chicago Tribune
Rush now offers a blood test to help detect more than 50 types of cancer, as other health systems remain wary
Jack Welter didn't feel sick when he agreed to take a new blood test that looks for multiple types of cancer. But, approaching 60, he thought it couldn't hurt. To his surprise, the test came back positive. Welter then underwent multiple rounds of follow-up tests, and ultimately, doctors found cancer in his throat. The now 61-year-old Elkhart, Indiana, resident endured radiation and chemotherapy in 2023 and is now cancer-free. 'Without that test, I still would have had (cancer), obviously, but it might not have appeared for another year or more,' said Welter, who is expecting his first grandchild. 'Early detection is the key to success.' In recent years, the blood test, called Galleri, and others like it, have been gaining momentum among doctors who use them to help detect cancers that otherwise might go unnoticed until patients become ill. Now, at least one local health system, Rush University System for Health, has decided to start offering Galleri to patients widely in hopes of finding cancer early, when it's easier to treat. The test has not yet been approved by the U.S. Food and Drug Administration and is not covered by most health insurance plans. At Rush, it will cost most people $749 out-of-pocket. Providers at other local health systems have expressed wariness about offering the test broadly at this point, given those concerns and others. But Rush leaders felt it was important to move forward with the test, given its potential life-changing benefits for patients and because of its performance in clinical trials, said Dr. Lisa Stempel, director of the high-risk cancer screening program at Rush. 'The goal of all screening is to find cancer early when we can treat it,' said Stempel, who noted that 1 in 3 people will get cancer in their lifetimes. 'It's such a simple test in the fact that it can find so many cancers and the fact that it can find it in early stages is what's extremely exciting to me.' The test works by identifying DNA in the bloodstream that's shed by cancer cells. It can detect a cancer signal shared by more than 50 types of cancer, and it can also reveal roughly where in the body the cancer might be. A positive result is not the same as a diagnosis. If a patient gets a positive result, the patient must undergo additional testing, such as CT scans or PET scans, to help assess if they really have cancer. There's a 43% chance that a positive test result will be cancer, according to a study from Grail, the company that makes the Galleri test. The test has a false positive rate of 0.5% among patients who don't have cancer, meaning about 1 out of every 200 people who take the test and don't have cancer might still get a positive result. The test is only available by prescription, and it's recommended annually by Grail for people at higher risk of cancer, such as those ages 50 and older. Rush is also offering it to younger adults with risk factors such as a family history of cancer, smoking, diabetes or obesity. If a patient gets a positive result but doctors can't find any cancer, Grail offers a second test to the patient free of charge. That's what happened to Welter, the Indiana patient who had throat cancer. The first time he took the test, it came back positive for cancer somewhere between his chest and head, he said. But more traditional follow-up tests didn't turn up any cancer. He then took a second, free Galleri test about six months later and, again, it was positive. He underwent more testing, and the second time around, doctors found the cancer. 'At that point in time it was so small they really couldn't pinpoint it,' Welter said of doctors' efforts to find the cancer after his first Galleri test. Welter has been speaking to doctors at Rush about his experience in recent months as part of their training to offer the tests to patients widely. Welter said he hasn't been paid by Grail nor Rush. 'To me it's amazing the test could actually find something like that,' Welter said. Not everyone, however, is as gung-ho about the test. Though health systems in other parts of the U.S. are also offering Galleri, some Chicago-area health systems and providers say they don't believe the test is ready for prime time. Northwestern Medicine is not systematically offering the Galleri test at this point, with a spokesperson saying, 'The technology isn't sufficiently sensitive and specific enough for us to use this as a screening tool at this time.' Feighanne Hathaway, a genetic counselor at UChicago Medicine, said she also has a number of concerns. For one, she worries that the out-of-pocket cost creates more disparities in health care. She also worries that the test may be less adept at picking up signals for early-stage cancers than later stage ones, raising questions about its usefulness and value. A Grail study found that 48% of confirmed cancers detected by Galleri were stages 1 or 2, and that adding Galleri to standard-of-care screening about doubled the number of cancers detected. Hathaway also fears that if a patient gets a negative test result, they may think they can forgo screenings such as mammograms and colonoscopies. Rush and Grail caution that the test is not meant to replace routine screenings. Largely, though, she's concerned that the test is not yet approved by the FDA. Hathaway said she likes the idea of the test, but, 'I just don't think we're there yet.' 'I think more research needs to be done before we start offering it,' Hathaway said. So far, more than 380,000 people are or already have participated in studies of Galleri, according to Rush. That includes a recently completed trial with 140,000 participants in the United Kingdom. The company is also sponsoring a clinical trial that's now seeking to enroll an additional 50,000 Medicare beneficiaries to test whether Galleri can help find cancer early and decrease the number of late-stage cancer diagnoses. Though Galleri is not approved by the FDA, Grail said it has been granted breakthrough device designation by the agency, which is meant to speed up development and review of devices that can more effectively treat or diagnose life-threatening and debilitating conditions. The company expects to finish submitting information to the FDA next year for premarket approval. 'Now, for the first time we've got breakthrough technology that can find cancer in adults who have no idea they have cancer, they have no symptoms, there's no suspicion of cancer, and we can look for more than those five cancers,' said Dr. Joshua Ofman, president of Grail, referring to the cancers that now have recommended screening tools, such as mammograms for breast cancer and colonoscopies for colorectal cancer. 'We can look for all the other cancers that are taking people's lives, because when you can find cancer early that is your best chance to cure it,' Ofman. Many patients feel the same way. Peter Crowell, 65 of Bucktown, was among the first group of Rush patients to sign up this month to be tested. After his primary care doctor mentioned it, Crowell made an appointment to get his blood drawn. 'He asked me if I was interested, given my history, so I said, 'Yeah,'' Crowell said, noting he has a family history of cancer. 'It's just something I think I'd rather be proactive about.' Of course, Crowell wishes insurance would pay for it, but he's willing to shell out the $749 for the test. He said he'll likely pay for it using a flexible spending account. 'If I can find out if I have any of those markers, then it will be worth it,' Crowell said. Maggie Hornung, a nurse practitioner at Rush, recently had her blood drawn for the test. It takes about three to four weeks to get results. 'I obviously was excited as a provider to start offering this and working on this but as a patient I absolutely wanted to proceed,' said Hornung, 58. She wanted to take the test because she's had family members with cancer, and because of what she's seen in her work with patients in the high-risk breast cancer clinic at Rush. 'To me, $749 is a small cost compared to what things could be,' Hornung said.
Business Insider
2 days ago
- Business Insider
FDA investigating death of child who received Sarepta's Elevidys
The U.S. FDA is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta (SRPT) Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The FDA has requested and received voluntary suspension of product distribution as it investigates the safety concerns. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
