Lab/diagnostics
The year’s news about lab and diagnostics
The year 2019 has been full of lab- and diagnostics-related news. Some developments point to a future far away – others right at hand. In either case, they offer points of conversation to share with customers.
Artificial intelligence and the lab
AI was one of the biggest stories of the year. For example, in July, Paige, a New York-based pathology company, announced that a study had found that its computational decision-support systems can help clinicians diagnose and treat cancer. That same month, Geisinger and its Steele Institute for Health Innovation announced it would collaborate with Medial EarlySign (Tel Aviv, Israel) to implement machine learning technology to identify individuals at risk for a range of chronic and high-burden diseases, such as significant lower gastrointestinal disorders. Meanwhile, researchers in a study funded by the National Institutes of Health said they demonstrated the effectiveness of using algorithms that analyze electronic health records to help physicians identify patients at risk for HIV who may benefit from preexposure prophylaxis.
But will AI ever make it to the physician’s office? “My impression is that it COULD help in identifying ‘best practice’ treatment for complicated diseases, such as most cancers and also the expanding array of lipid markers,” says lab expert and Repertoire contributor Jim Poggi. “I imagine a day where, as a first step, the physician enters a presumptive diagnosis or set of symptoms and the expert AI system suggests a more refined diagnosis and offers a suite of tests to confirm it. Then, either the outside lab or the POL performs these tests and inputs the results, and the output confirms the diagnosis and suggests best practice course of treatment, assuming one exists.”
Diagnostic errors
A study published in the journal Diagnosis in March found that diagnostic errors remain the most common, most catastrophic, and most costly of serious medical errors in closed malpractice claims. Researchers examined over 55,000 closed claims and 11,600 diagnostic error cases, and found that the Big Three diseases – vascular events, infections and cancers – accounted for 74.1 percent of high-severity cases (22.8 percent vascular events, 13.5 percent infections and 37.8 percent cancers). The most frequent disease in each category, respectively, was stroke, sepsis and lung cancer.
Meanwhile, ECRI Institute identified “diagnostic stewardship and test result management using EHRs” as one of its Top Ten Patient Safety Concerns of 2019. “When diagnoses and test results are not properly communicated or followed up, the potential exists to cause serious patient harm or death,” writes ECRI in its annual report. “Providers have begun relying on the electronic health record to help with clinical decision support, to track test results, and to flag issues. However, the EHR is only part of the solution.
“To help ‘close the loop,’ providers must not only fully utilize an EHR designed to meet their practices’ unique needs, but also recognize the importance of clear communication, both among caregivers and between caregivers and patients.”
Sexually transmitted infections
The U.S. Food and Drug Administration in May cleared for marketing two new tests to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause, respectively, chlamydia and gonorrhea, through diagnostic testing of extragenital specimens. The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum. These tests were previously only cleared for testing urine, vaginal and endocervical samples.
Meanwhile, in June, SpeeDx Pty. Ltd. (Sydney, Australia) announced that the FDA granted Breakthrough Device designation for ResistancePlus GC, expediting the path towards FDA clearance. The test is said to be the first commercially available molecular test providing information on ciprofloxacin susceptibility and resistance in the treatment of N. gonorrhea. Results from the test can be used to guide treatment decisions for gonorrhea infections, giving doctors and patients the option of using ciprofloxacin instead of ceftriaxone, one of the last remaining antibiotics available for multi-drug resistant infections.
The rate of sexually transmitted infections is steadily increasing, with an estimated 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea in the U.S. in 2017 alone, according to the Centers for Disease Control and Prevention.
Patient’s breath to detect cancer?
Mayo Clinic Laboratories reported in March that it would team up with Breath Diagnostics (Tustin, California) to develop clinical diagnostic tests that use patient breath samples to identify individual biomarkers that can predict a spectrum of diseases. (Biomarkers are measurable substances that help in predicting the severity of a disease or infection, according to Mayo.) The first collaboration will focus on a test that detects lung cancer using patients’ exhaled breath. The test will be used to characterize indeterminate pulmonary nodules and monitor for potential cancer recurrence after surgery.
“A CT scan can only identify the presence of suspicious pulmonary nodules, and many patients require repeated follow-up CT and PET scans or other invasive follow-up procedures like needle biopsies,” said Brian Ennis, president and CEO of Breath Diagnostics. “Our technology is noninvasive and will be a lower cost alternative.”
HIV testing
The vast majority (about 80 percent) of new HIV infections in the U.S. in 2016 were transmitted from the nearly 40 percent of people with HIV who either did not know they had HIV, or who received a diagnosis but were not receiving HIV care, the CDC reported in March.
The findings of the CDC report include:
- The nearly 15 percent of people with HIV whose infections are undiagnosed account for almost 40 percent of all HIV transmissions.
- The roughly 23 percent of people with HIV whose infections are diagnosed, but who are not receiving HIV care, account for 43 percent of all HIV transmissions.
- The 11 percent of people with HIV who are receiving care, but are not virally suppressed, account for 20 percent of all HIV transmissions.
When taken as directed, antiretroviral therapy reduces the amount of HIV in the body to a very low level – also known as viral suppression, says CDC. Studies indicate that people who are virally suppressed can protect their own health and have effectively no risk of transmitting HIV to others through sex, as long as they stay virally suppressed.
Unnecessary blood tests
Hospitals can decrease the frequency of unnecessary blood tests by educating resident physicians – that is, making them cost-conscious and aware of the indications for ordering routine labs, researchers reported in January in the Postgraduate Medical Journal. But frequent reminders are needed to sustain the educational benefit. The researchers were testing guidelines of “Choosing Wisely” (www.choosingwisely.org), an initiative of the ABIM Foundation that seeks to identify and advance a national dialogue on unnecessary medical tests, treatments and procedures.
An eight-week initiative aimed at reducing unnecessary blood tests was implemented in three internal medicine resident inpatient services. The initiative included a 30-minute educational session, reminders prior to rotation and midrotation, and posters in work areas that displayed lab pricing. Residents were encouraged to justify the purpose of ordering tests in their daily progress notes. Attending physicians were made aware of the initiative.
There were 293 patient records reviewed in the preintervention period and 419 in the postintervention period. The two groups were similar in terms of age and gender. Median blood test count (complete blood count/basic metabolic profile/comprehensive metabolic profile) decreased from four to two tests per patient per day after the intervention. The median length of hospital stay decreased from 4.9 to 3.9 days. A decreased percentage of people requiring transfusions was also noted – 6.1% in 2016, 2.9% in 2017).