Blood Test Offers New Hope for Early Cancer Detection

Jack Welter didn’t feel any illness when he opted for a new blood test designed to detect multiple types of cancer. But nearing 60, he figured, why not? It seemed like a reasonable choice.

To his astonishment, the results were positive. After several follow-up tests, doctors diagnosed him with throat cancer. Now, at 61 and based in Elkhart, Indiana, he has completed radiation and chemotherapy and is cancer-free.

“Without that test, I definitely would have had cancer, but it might not have shown up for another year or more,” Welter reflected, sharing his excitement about becoming a grandparent soon. “Early detection is crucial for success.”

In recent years, the Galleri blood test and similar tests have gained traction among doctors as tools for spotting cancers that might otherwise remain hidden until symptoms arise. Now, Rush University System for Health is rolling out Galleri widely, aiming to catch cancer early when it’s more manageable.

This test hasn’t yet received FDA approval and isn’t typically covered by health insurance, with Rush charging around $749 for those who pay out of pocket. Some local health providers have shown hesitation in offering it broadly due to these concerns.

But Dr. Lisa Stempel, director of the high-risk cancer screening program at Rush, emphasized the test’s potential benefits, stating, “The aim of all screening is early detection when treatment options are available.” She noted that one in three individuals will face cancer in their lifetime, making the ability to identify multiple types at early stages particularly compelling.

The test picks up DNA shed by cancer cells in the bloodstream and can indicate the presence of over 50 types of cancer, potentially pinpointing their locations in the body.

A positive test result, however, doesn’t equate to a cancer diagnosis. Patients with positive results must undergo further testing, like CT or PET scans, to confirm any issues.

According to a study by Grail, the company behind the Galleri test, there’s a 43% likelihood that a positive result indicates cancer. The false-positive rate stands at 0.5%, meaning about one in 200 tests might yield a positive result for someone who doesn’t have cancer.

This test is accessible only through a prescription and is suggested annually for higher-risk individuals, including those aged 50 and above. Rush is also offering it to younger adults with specific risk factors, such as a family cancer history, smoking, diabetes, or obesity.

If a patient receives a positive result but no cancer is located, Grail offers a follow-up test free of charge. This was the case for Welter, whose first test indicated cancer somewhere between his chest and head; however, traditional tests found nothing. A second Galleri test, taken several months later, also yielded positive results, leading to the eventual cancer diagnosis.

“The cancer was so small initially that it was hard for the doctors to locate,” Welter explained. He has been consulting with Rush about his experiences as they train to offer the test more widely. He mentioned he hasn’t received any compensation for his input.

“It’s impressive that the test could detect something like that,” Welter stated.

Despite such success stories, not all healthcare systems are fully on board. Some providers in the Chicago area have expressed concerns about the test’s readiness for widespread use.

Northwestern Medicine is not currently offering the Galleri test systematically, stating that “the technology isn’t sensitive and specific enough for us to use as a screening tool at this time.”

Feighanne Hathaway, a genetic counselor at UChicago Medicine, shares several concerns. She worries about the out-of-pocket costs creating disparities in healthcare and believes the test may not be as effective for early-stage cancers compared to later stages. A study indicated that only 48% of confirmed cancers detected by Galleri were at stages 1 or 2.

She also noted the risk that some individuals might forgo standard screenings like mammograms or colonoscopies following a negative test result. Both Rush and Grail caution that this test is not intended to replace routine screening methods.

Primarily, she’s worried about the test not getting FDA approval, stating, “I like the concept, but I don’t think we’re at that point yet.”

According to Rush, over 380,000 individuals have taken part in Galleri studies, including a recent trial in the UK involving 140,000 participants. Grail is also sponsoring a clinical trial aiming to enroll an additional 50,000 Medicare recipients to explore whether Galleri can enhance early detection and reduce late-stage cancer diagnoses.

Though lacking FDA approval, Grail has received the breakthrough device designation to expedite the review process for potentially life-saving technology. They anticipate submitting information for premarket approval next year.

“For the first time, we have breakthrough technology that can identify cancers in people who exhibit no symptoms or suspicion, and identify more cancers beyond the five currently screened for,” explained Dr. Joshua Ofman, president of Grail. “Detecting cancer early is the best path to treatment.”

This sentiment resonates with many patients. Peter Crowell, 65, from Bucktown, was among the first at Rush to undergo testing after discussing it with his doctor. With a family history of cancer, he felt proactive action was essential.

“It’s something I’m willing to invest in, even if I wish insurance would cover it,” Crowell noted, planning to use a flexible spending account for the $749 fee.

“Discovering any markers would make it worthwhile,” he added.

Maggie Hornung, a nurse practitioner at Rush, also completed her own test recently, noting it takes about three to four weeks for results. She was eager to participate both as a provider and a patient, influenced by family cancer histories and her work with high-risk patients.

“In my view, $749 is a small price to pay compared to potential outcomes,” Hornung concluded.