Did laboratory testing ever hold a higher profile among the public than it did in late winter with COVID-19? Maybe not. But despite the focus on COVID-19, other lab-related news of interest to Repertoire readers and their customers continued to unfold.
Blood biopsies, molecular diagnostics and artificial intelligence are just some of the technologies shaping the future of diagnostics. Some have found their way into the physician’s office; others will follow. In either case, here are some recent developments for sales reps to keep in mind on their calls.
Can’t. Stop. Testing.
Ask your physician customers: “How often do you find yourself ordering follow-up tests or even procedures following incidental findings, that is, findings unrelated to the primary objective of the screening or diagnostic test?”
Now ask, “How many of those follow-up tests fail to turn up anything of clinical importance to the patient – or worse, cause some kind of harm to the patient from a physical, financial or emotional perspective?”
According to a study published in October 2019 by JAMA Network, the answer is “Many.”
Among 376 practicing U.S. internists in a nationally representative survey study, most reported that they had experienced or initiated so-called “cascades” after incidental findings that failed to lead to clinically important and intervenable outcomes yet caused harm to patients and themselves.
Such cascades commonly included telephone calls with patients (21.7% reported them at least weekly), new noninvasive tests (16.1% at least weekly), and repeated tests (14.7% at least weekly). In addition, most physicians had experienced a cascade for their patient that led to a new invasive test (77.2%), emergency department visit (54.8%), or hospitalization (50.6%).
Physicians reported cascades caused their patients psychological harm (68.4%), physical harm (15.6%) and financial burden (57.5%), and caused the physicians wasted time and effort (69.1%), frustration (52.5%), and anxiety (45.4%). When asked about their most recent cascade, 33.7% of the respondents said the test revealing the incidental finding may not have been clinically appropriate. During their most recent cascade, physicians reported that guidelines for follow-up testing were not followed (8.1%) or did not exist to their knowledge (53.2%).
What does the future hold? Although only 19.9% of physicians reported that they ordered follow-up testing because their patient asked for it, the researchers expect patients to have a bigger role in testing in the future as they gain increased access to laboratory and radiology results through electronic portals.
And the solution?
Almost 63% of the physicians believed that accessible guidelines on how to manage incidental findings would help limit the negative consequences of cascades, 48.1% said patient and clinician education on potential harms from unnecessary medical care would help, 44.6% identified decision aids (i.e., shared decision-making tools for physician and patient), and 42% chose malpractice reform. (Of the almost one-fifth of responding physicians who reported personal experience of a medical malpractice lawsuit, 11.4% said they had been sued for failing to follow up on an incidental finding.) Much fewer thought that patient cost-sharing (18.1%) or value-based payment models (16.2%) would help.
The researchers believe the results of their study highlight the importance of patient engagement, including talking to patients about the possibility of incidental findings and potential courses of action even before ordering a test.
Colorectal cancer and younger individuals
The burden of colorectal cancer is swiftly shifting to younger individuals. In fact, half of all new diagnoses are in people 66 or younger, according to Colorectal Cancer Statistics 2020, a publication of the American Cancer Society. Put another way, the median age of diagnosis has dropped from age 72 in 2001-2002 to age 66 during 2015-2016.
Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in both men and women in the United States. Rapid declines in CRC incidence occurred in people 50 and older during the 2000s, largely because of increased screening with colonoscopy, which can prevent cancer by removing premalignant polyps.
“Timely diagnosis among young patients remains critical while we await answers to why CRC incidence is rising in young and middle-aged adults,” Rebecca Siegel, MPH, lead author of the report, was quoted as saying.
The ‘Kidney Profile’
More than 30 million Americans are estimated to be living with chronic kidney disease, but only about 3.6 million are aware they have it, according to the American Society for Clinical Pathology (ASCP). Now, ASCP, the National Kidney Foundation and a group of laboratory providers and clinical laboratory societies have announced a new collaboration intended to make it easier for primary care physicians to determine if an at-risk patient has kidney disease.
The organizations have recommended a new test profile – a so-called “Kidney Profile” for CKD assessment and diagnosis. The profile follows evidence-based clinical practice guidelines, which recommend two tests for CKD assessment: the estimated glomerular filtration rate (eGFR), which assesses kidney function; and urine albumin-creatinine ratio (ACR), which assesses kidney damage. Both are used to test for and diagnose CKD in primary care settings.
Laboratories adopting the “Kidney Profile” will simplify ordering of the tests needed to detect and diagnose CKD by pairing them together under one heading on the laboratory requisition form or electronic health record order. Such streamlining of CKD test ordering could help to eliminate the need to search for each test separately and increase the ease of monitoring results. The “Kidney Profile” also makes it easier for people at risk for CKD to better understand and track their health.
Your odds of ischemic stroke
In the future, with just one blood draw, providers may be able to identify people at a particularly high risk of ischemic stroke, the most common kind of stroke, reports Cardiovascular Business News. By knowing their “genetic risk score,” patients can manage their risk factors earlier and more effectively, according to researchers from the Baker Heart and Diabetes Institute in Australia and the University of Cambridge in the U.K., who reported their findings in “Nature Communications.” The teams employed machine learning to integrate stroke-related genetic data from a variety of research projects, then tested the model in a population of 420,000 individuals enrolled in the UK Biobank. Using the score, they could detect the roughly one in 400 individuals at a threefold risk of ischemic stroke, which occurs when a vessel supplying blood to the brain is obstructed.
Sidebar:
The zig and zag of COVID-19 testing
Crazy times in the final month of winter
After a botched early attempt by the Centers for Disease Control and Prevention to produce and disseminate testing COVID-19 kits early this year, the agency regained its balance and corrected the problem. In February, the U.S. Food and Drug Administration issued guidance to accelerate the availability of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers during what the Secretary of Health and Human Services called a “public health emergency.” In mid-March the FDA said it would allow individual states to authorize the use of laboratory-developed tests by qualified in-state labs without applying with the FDA for an “Emergency Use Authorization,” or EUA.
Diagnostics companies and reference labs responded rapidly with tests to be performed in high-complexity CLIA labs. They include:
- Hologic: Panther Fusion SARS-COV-2 Assay.
- Laboratory Corporation of America (LabCorp): COVID-19 RT-PCR test.
- Roche: cobas SARS-CoV-2 test.
- Qiagen: QIAstat-Dx Respiratory 2019-nCoV Panel
- Thermo Fisher Scientific: Applied Biosystems TaqPath Assay
- Quidel Corp: Lyra® SARS-CoV-2 Assay.
- Abbott Molecular: RealTime SARS-CoV-2 assay
- Quest Diagnostics: SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR
In late March, two companies – EverlyWell and Nurx – announced the availability of at-home COVID-19 diagnostic tests. And on March 21, the FDA granted “emergency use authorization” to Cepheid for the first point-of-care coronavirus test … just as questions were being raised about the value of testing the public as a strategy to contain the outbreak!