Frontline staff in the Central Clinical and Central Processing Laboratories in the division of Clinical Core Laboratory Services (CCLS) made an astute observation that more tubes of blood were being collected from patients than seemed necessary. Analysis pointed to a potential benefit of new laboratory automation equipment and technology. The previous automation line in Central Processing required all tubes loaded in a rack to be the same height and serum aliquoted into cups for testing. The new automation line can accept varying tube sizes/heights and sends tubes directly to the analyzer, which reduces the amount of blood needed for testing. The lab teams seized this opportunity to make a change.

Intent on improving the patient experience, realizing supply efficiencies, and achieving cost savings for the enterprise, the lab teams enlisted the sponsorship of Drs. Nikola Baumann, Darci Block, Matthew Binnicker, Brad Karon, and administrative sponsors Adi Singh and Tim Faber. Together, an operational excellence goal emerged.

The team moved forward with its first pilot involving updating the collection and roll-up of blood volumes for 111 CCLS Rochester tests. A recent go-live on Feb. 20 included 94 test updates. Based on the post-go-live data, the results equate to a 59% decrease in blood volumes collected, which would be 1,071L/283 gallons reduction annually. Considering that the average human body has about 1.3 gallons of blood, the effect of this improvement is immense.

There was a corresponding 41% decrease in SST tubes for this project. That’s 2,891 fewer tubes per week, or $24,076 cost savings per year. No adverse effects to “quantity insufficient” (QNS), redraws, or add-ons have been detected. This not only benefits patient safety and satisfaction because less blood is collected but also conserves blood collection tubes and reduces supply chain demands.

The project evolved quickly into a program. With dedicated support, the team is forming cross-divisional partnerships across the enterprise to bring forward project ideas and pilots, all focused on blood and tube optimization. The benefits? Not only is there potential for greater patient safety and satisfaction and supply conservation, but fewer blood tubes might reduce the potential for manual errors in labeling and sample mix-ups and reduce the load on the overall system. Fewer tubes also have the potential to improve test turnaround time.

This first project is just the beginning and is considered proof of concept. There are four more projects currently getting started in the program.

Special thanks to the efforts of so many, but in particular: Dr. Binnicker, Dr. Baumann, Dr. Block, Dr. Karon, Adi Singh, Tim Faber, Sherry Boedecker, Sam Crosby, Elaine Elliott, Erin Hain, Brenda Hendrix, Sharon Johnson, BJ Krekelberg, Sara Minnich, Ryan Nett, Aaron Stelpflug, Jennifer Storlie, Chris Yoch, the Lab Test Catalog Team (Karen Kloke and Kristina Erath Pike), and the Test Implementation Service Team (Maxwell Cain, Shanna Hanson, Sean King, Melissa Rivera, Ryan Ritzer, and Kimberly Smalley).

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Mayo Clinic medical research websites:

• Research at Mayo Clinic
• Discovery’s Edge
• Mayo Clinic Laboratories
• Center for Individualized Medicine
• Center for Regenerative Biotherapeutics
• Center for the Science of Health Care Delivery
• Mayo Clinic Comprehensive Cancer Center

The post Science Saturday: Blood Tube Optimization Program hails first successful project appeared first on Mayo Clinic News Network.

Mayo Clinic today recognized the debut of a groundbreaking multi-cancer early cancer detection (MCED) test called Galleri™ that can detect more than 50 types of cancers^[1] through a simple blood draw. The Galleri test is intended  to complement U.S. guideline-recommended cancer screenings.

Mayo Clinic Oncologist Minetta Liu, M.D. was involved in the development of the new test.

“Today, many cancers are found too late, leading to poor outcomes,” says Dr. Liu. “The ability to detect cancer early is critical to successful treatment.”

Cancer is expected to become the leading cause of death in the U.S. this year. Currently recommended cancer screening tests only cover five cancer types and screen for a single cancer at a time. In fact, there are no recommended early detection screening tests for other cancers, which account for 71% of cancer deaths.

Researchers used the Galleri test in the Circulating Cell-free Genome Atlas (CCGA) Study, a prospective, observational, longitudinal study designed to characterize the landscape of genomic cancer signals in the blood of people with and without cancer. In the study, the Galleri test demonstrated the ability to detect more than 50 types of cancers — over 45 of which have no recommended screening tests today — with a low false-positive rate of less than 1%.

According to Dr. Liu, when a cancer signal is detected, the Galleri test can identify where in the body the cancer is located with high accuracy — a critical component to help enable health care providers to direct diagnostic next steps and care.

“We are grateful to Mayo Clinic for its dedication to advancing new technologies for early cancer detection and for playing a pivotal role in the development of Galleri,” says Dr. Josh Ofman, chief medical officer and head of external affairs at GRAIL.“A simple blood test capable of detecting more than 50 cancers is a ground-breaking advancement and could have a tremendous human and economic benefit.”

Initial results from the interventional PATHFINDER Study, which involved the return of Galleri test results to providers to communicate to participants, were presented today at the 2021 American Society of Clinical Oncology Annual Meeting. They demonstrate Galleri’s performance in the clinical setting was consistent with findings from previous observational studies, underscoring the potential real-world ability of Galleri to find deadly cancers earlier.

The Galleri test is for those at an elevated risk of cancer, such as adults age 50 or older and is available by prescription only.

Dr. Liu is the co-director of the Genomics in Action Program within the Mayo Clinic Center for Individualized Medicine, research chair of the Department of Oncology, and a consultant in the Department of Laboratory Medicine and Pathology. Dr. Liu conducts patient-oriented research focused on developing clinically relevant molecular markers to allow for the most accurate prediction of treatment benefit and patient outcomes in solid tumor malignancies. She also researches multi-cancer early cancer detection through blood assays and develops novel therapeutics to improve survival in early-stage and metastatic breast cancer.

^[1] Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV, Liu MC, Oxnard GR, Klein EA, Smith D, Richards D, Yeatman TJ. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020;31(6):745-59.

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Watch: The Mayo Clinic Minute

Journalists: Broadcast-quality video (:56) is in the downloads. Read the script.

Ouch. That needle can sting. But your blood holds clues about your health.

“For routine blood tests, generally, we do what we call a complete blood count,” says Dr. Pruthi.

A CBC. Dr. Pruthi says a CBC measures components in your blood. Your bone marrow is like a blood factory. It produces red cells, white cells and platelets. If, during a blood test, the levels of these components are too high or too low, your doctor may order further testing to find out why.

“Sometimes patients may have minimum or no symptoms, and the first sign is abnormalities on your complete blood count,” says Dr. Pruthi.

So a CBC is a screening test.

“Which, in conjunction with the patients history and physical exam, will lead to a diagnosis if there are abnormalities,” says Dr. Pruthi.

Yes, that needle might pinch, but Dr. Pruthi says it’s important to talk to your health care provider about getting a complete blood count at regular intervals.

The post Mayo Clinic Minute: Blood test basics appeared first on Mayo Clinic News Network.

ROCHESTER, Minn. — A simple blood test could improve treatment for more than 1 in 6 stage 2 colon cancer patients, suggests new Mayo Clinic research. The researchers also discovered that many patients who could benefit from the test likely aren’t receiving it. The findings were published in the Journal of Gastrointestinal Surgery.

Using data from the National Cancer Database for 40,844 patients, Mayo Clinic physicians and scientists teamed up to look at benefits of a blood test that measures the protein called carcinoembryonic antigen, or CEA, in stage 2 colon cancer. Carcinoembryonic antigen can be found in higher levels in people with certain cancers, especially colon cancer.

The researchers found that knowing these blood test results prior to treatment could have changed the classification for 17 percent of stage 2 colon cancer patients from average risk to high risk. That change could have altered treatment options, including whether to use chemotherapy.

“The decision to give a patient chemotherapy after surgery is not a light one, and physicians must weigh the risks and benefits,” says senior author Kellie Mathis, M.D., a Mayo Clinic colon and rectal surgeon. “We are currently using the blood test to help make these difficult decisions, and we suggest other physicians do the same.”

The blood test has been around for decades but is not broadly used across the country. It was recorded in 54 percent of cases meeting other relevant criteria for the study. While in some cases the test may not have been entered in the database, many other patients may not be getting it.

“There is no good reason for a physician to omit this blood test, and more work needs to be done to ensure that all patients receive it,” Dr. Mathis says.

When patients get the blood test, the authors point out it is often done after surgery to monitor the cancer’s development. Greater, and earlier, consideration of protein level may be warranted, the researchers say.

Colorectal cancer is the fourth most common cancer in the U.S. and the second deadliest.

There are four primary stages of colon cancer. Generally, with stage 2, the cancer hasn’t spread to nearby lymph nodes or distant organs but has grown into or through the wall of the colon. Some stage 2 patients fare worse than some stage 3 patients, who usually benefit most from chemotherapy. But the research team believes this blood test can help determine which stage 2 patients are at a higher risk and therefore could benefit from therapy.

The researchers also discovered that, for stage 2 patients who had surgery but not chemotherapy, the five-year survival rate was 66 percent for those with elevated protein levels and 76 percent for those without elevated levels. And for patients with elevated protein levels, those who had chemotherapy and surgery fared better than those who only had surgery.

“If a patient with a new diagnosis of stage 2 colon cancer has an elevated carcinoembryonic antigen level, physicians should consider chemotherapy in addition to surgery,” says Dr. Mathis.

To perform the patient-centered research, physicians in the Mayo Clinic Division of Colon and Rectal Surgery collaborated with scientists in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

The lead author is Blake Spindler, M.D., a resident in the Mayo Clinic School of Graduate Medical Education. The other authors are John Bergquist, M.D., and Cornelius Thiels, D.O., both residents in the Mayo Clinic School of Graduate Medical Education, and Elizabeth Habermann, Ph.D., Scott Kelley, M.D., and David W. Larson, M.D., all from Mayo Clinic.

The study was funded by the Mayo Clinic Department of Surgery, the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery and the Mayo Clinic Clinician-Investigator Training Program.

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit mayoclinic.org/about-mayo-clinic or newsnetwork.mayoclinic.org.

MEDIA CONTACT
Adam Harringa, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

The post Underused cancer test could improve treatment for thousands, Mayo Clinic study finds appeared first on Mayo Clinic News Network.

"We were very pleased to see those results," says Dr. David Ahlquist, a Mayo Clinic gastroenterologist who previously worked with Exact Sciences to develop a colon cancer test called Cologuard. "This new test approach that targets novel DNA markers had a sensitivity of 96 percent for lung cancer detection at 94 percent specificity."

Doctors say further research is needed, but the test shows promise for becoming a valuable new tool in the fight against lung cancer, the No. 1 cancer killer in the U.S.

"We know we can save lives if we find it early enough," says Dr. David Midthun, a Mayo Clinic pulmonologist. "And, potentially, we could find it even earlier with a blood test than with a CT scan."

In this Mayo Clinic Radio Health Minute, Drs. Ahlquist and Midthun explain how the test works and why it has the potential to change the way you’re screened for lung cancer.

To listen, click the link below.

Blood-based lung cancer test shows promise

The post Blood-based lung cancer test shows promise: Mayo Clinic Radio Health Minute appeared first on Mayo Clinic News Network.

"We were very pleased to see those results," says Dr. David Ahlquist, a Mayo Clinic gastroenterologist who previously worked with Exact Sciences to develop a colon cancer test called Cologuard. "This new test approach that targets novel DNA markers had a sensitivity of 96 percent for lung cancer detection at 94 percent specificity."

Doctors say further research is needed, but the test shows promise for becoming a valuable new tool in the fight against lung cancer, the No. 1 cancer killer in the U.S.

"We know we can save lives if we find it early enough," says Dr. David Midthun, a Mayo Clinic pulmonologist. "And, potentially, we could find it even earlier with a blood test than with a CT scan."

In this Mayo Clinic Minute, Drs. Ahlquist and Midthun explain how the test works and why it has the potential to change the way you’re screened for lung cancer. Jeff Olsen reports.

Watch: The Mayo Clinic Minute

Hear more from the doctors:

• Dr. Midthun discusses the prevalence of lung cancer in the U.S.
• Dr. Ahlquist explains the findings of the lung cancer blood test study.
• Dr. David Midthun discusses what the prototype lung cancer blood test means for the future.
• Dr. David Midthun explains how a blood-based lung cancer test could reduce concern and additional procedures.

Journalists: Broadcast-quality video is in the downloads. Read the Mayo Clinic Minute script (1:00).

The post Mayo Clinic Minute: Blood-based lung cancer test shows promise appeared first on Mayo Clinic News Network.

The researchers' findings will be presented on April 21 in a poster presentation at the AACR Annual Meeting 2015 in Philadelphia by John Kisiel, M.D., a gastroenterologist at Mayo Clinic.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

Journalists: Sound bites with Dr. Kisiel are available in the downloads.
https://youtu.be/DbDHEpZWteQ
“What’s exciting about our discovery is that it allows us to stop thinking about screening organs and start thinking about screening people,” says Dr. Kisiel. “As far as we are aware, this is the first series of experiments that has ever shown this concept.” He and his colleagues studied cancer-free patients as well as patients with cancers of the colon or pancreas. By collecting and identifying methylated DNA in a blood test, they were able to identify the presence and origin of the cancerous cells with about 80 percent accuracy. “We think, based on the data we have, that a blood test could work in the future,” Dr. Kisiel says.

Researchers double-checked their results by examining methylated DNA in tissue samples, identifying the origin of tumors with greater than 90 percent accuracy. “Our work in tissue shows that we have fairly high precision,” says Dr. Kisiel, “but you can’t do a screening test in tissue, because you can’t biopsy all these tissues at once as part of a screening test. That would not be practical.”

The organ-by-organ search for cancer is precisely what Dr. Kisiel and colleagues hope to make unnecessary. While biopsies of organs have saved lives from common malignancies such as breast or prostate cancer, “we can’t screen for the less common cancers because the risk of false-positive diagnoses is too high,” says Dr. Kisiel. Doctors would unnecessarily worry patients and spend too much time and expense chasing cancers that may not exist. As a result, he says, “a cancer like pancreatic cancer, although it’s almost uniformly lethal, is not screened for at all in the general population, mainly because it’s rare.”

Finding and correctly identifying distinctive methylated DNA from the cancers in a blood or stool sample may change all that. “DNA methylation may be a way to fingerprint not only the tissues themselves, but also the different types of cancer that might arise in those tissues,” Dr. Kisiel says.

“We hope that in the future patients might be able to submit a blood specimen and then we can analyze that blood specimen for the presence and absence of cancer markers. And if they are present we hope to be able to determine the anatomic location of the tumor, or the organ from which it originates,” he says.

Dr. Kisiel’s research applied specifically to the gastrointestinal tract. “We’ve not yet tested this concept in cancers throughout the entire body, but that is the next step,” he says.

Under the best of circumstances, comprehensive cancer screening by blood or stool sample won’t be ready any time soon. “Patients shouldn’t be waiting for this to come to their physician’s office,” says Dr. Kisiel. “They should be working with their doctors to get screening tests that are currently available.”

About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit http://mayocl.in/1ohJTMS, or https://newsnetwork.mayoclinic.org/.

The post Mayo Clinic Researchers Identify Methylated DNA Markers That May One Day Lead To Noninvasive Whole Body Cancer Screening appeared first on Mayo Clinic News Network.

Mayo Clinic pharmacologist and co-author Eugenia Trushina, Ph.D., says, "We want to use these biomarkers to diagnose Alzheimer’s disease before symptoms appear — which can be decades before people start exhibiting memory loss. The earlier we can detect the disease, the better treatment options we will be able to offer."

The study was recently published online in the journal PLOS ONE.

Read entire news release: Alzheimer's Blood Test

Journalists: Sound bites with Dr. Trushina are available in the downloads

The post New Mayo Clinic Approach Could Lead to Blood Test to Diagnose Alzheimer’s appeared first on Mayo Clinic News Network.