An essential tool in precision medicine is companion diagnostics, which are medical devices used to assess critical information about the safety and effectiveness of corresponding drugs or biologic products. However, most conventional companion diagnostics are limited by their inability to test multiple genes or assess a broad range of genomic changes that can inform disease identification and care decisions.
Three systematic reviews and 1 randomized controlled trial about the clinical utility of screening for asymptomatic bacteriuria versus no screening in people who are pregnant and are not at risk for bacteriuria were identified.
No literature about the clinical utility of screening for asymptomatic bacteriuria with different screening approaches or algorithms in people who are pregnant and are not at high risk for bacteriuria was identified.
Six evidence-based guidelines about the use of screening for asymptomatic bacteriuria in people who are pregnant and are not at high risk for bacteriuria were identified.
This Horizon Scan summarizes the available information regarding the emerging technology of liquid biopsy–based multi-cancer early detection tests for cancer screening. This scan focuses specifically on the Galleri (GRAIL Inc.) and CancerSEEK (Exact Sciences) tests, which are further along in the development cycle and are being assessed in different international clinical studies.
No relevant literature was identified regarding the diagnostic test accuracy, clinical utility, and cost-effectiveness of serum folate testing in people with suspected folate deficiency.
Additionally, no evidence-based guidelines were identified regarding the use of serum folate testing in people with suspected folate deficiency.
Findings from 3 diagnostic accuracy studies indicate that individual tests are insufficient to diagnose vitamin B12 deficiency, and a testing strategy that uses homocysteine and methylmalonic acid should be used in individuals suspected or at risk of vitamin B12 deficiency. This is supported by a health technology assessment that concluded that the current evidence does not provide enough information to determine the most appropriate test, or combination of tests to use in these patients.
The patient populations varied in the primary studies included in the systematic reviews and in the primary studies identified in this review, which may impact the generalizability of the results.
Reference standards and cut-off values (i.e., thresholds) used to diagnose vitamin B12 deficiency varied in the primary studies. Presentation of units (e.g., pg/mL, pmol/L) also varied, making it difficult to compare results across studies.
No studies were identified that evaluated the clinical utility of vitamin B12 testing in people with suspected vitamin B12 deficiency.
No studies were identified that evaluated the cost-effectiveness of vitamin B12 testing in people with suspected vitamin B12 deficiency.
No evidence-based guidelines were identified regarding the use of vitamin B12 testing in people with suspected vitamin B12 deficiency.
One evidence-based guideline was identified regarding maximum blood draws for pediatric patients.
One health technology assessment and 6 non-randomized studies were identified regarding the diagnostic test accuracy of transcutaneous bilirubin screening compared with serum bilirubin testing for well newborns in hospital. One health technology assessment and 1 randomized controlled trial were identified regarding the clinical effectiveness of transcutaneous bilirubin for well newborns in hospital. One health technology assessment and 1 economic evaluation were identified regarding the cost-effectiveness of transcutaneous bilirubin screening for well newborns in hospital. One evidence-based guideline was identified regarding transcutaneous bilirubin screening for well newborns in hospital.
An update to a 2020 CADTH Rapid Review was conducted to capture new literature published since 2019 examining the effectiveness of drug treatment informed by genetic testing compared to usual care for adults with depression. Eleven studies were identified: 1 systematic review, 1 health technology assessment, 4 randomized controlled trials reported in 5 publications, 1 non-randomized study, 1 cohort study with historical control, and 2 uncontrolled before-and-after studies. Similar to the conclusions of the 2020 CADTH report, the effectiveness of gene testing for treating depression was unclear. In patients with depression, some studies showed that there were improvements in the clinical effectiveness outcomes in those who received gene testing and other studies showed that there was no difference in outcomes between those who received gene testing and those who did not. No studies showed that gene testing resulted in worse outcomes compared to those who did not receive gene testing. In the current report, the were several limitations across studies such as poor design, inclusion of subjectively measured outcomes, small sample sizes, and a focus on hospital settings all of which may not be generalizable to other populations.
This Horizon Scan summarizes the available information regarding the use of self-sampling devices for HPV testing as part of cervical cancer screening programs.
HPV testing for primary cervical cancer screening is not currently a part of any Canadian screening programs. However, several provinces are in the process of implementation and some pilot testing.
Self-sampling is generally as accurate as clinician-collected sampling for HPV testing.
Self-sampling devices for HPV testing could likely be used to increase participation in cervical cancer screening programs.
There is a lack of evidence on the clinical utility of the interferon gamma release assay for identifying latent tuberculosis infection in rural and remote settings. In remote Indigenous communities with known history of bacillus Calmette-Guérin vaccination, more positive tests results were reported with the tuberculin skin test than with the interferon gamma release assay.