Meets most of The World Health Organization’s ASSURED criteria for remote testing: 1
- Deliverable to end users
Future Growth in Molecular Diagnostic Testing is Outside the Traditional Laboratory:
Three major changes in the healthcare field:2
(1) reduction in inpatient admissions that is driving the growth of bedless or mini-hospitals;
(2) provision of first-tier outpatient care in walk-in clinics such as CVS MinuteClinic®
(3) the transfer of some inpatient care to patients’ homes, partly as a cost-reduction strategy.
- Enables more rapid clinical decision making in the process of diagnosis, (rule-in or rule-out), treatment choice and monitoring, and prognosis, as well as operational decision making and resource utilization.
Clinics & Urgent Care Centers
- Improve patient care with real-time treatment recommendations.
67,000 Pharmacies in US 3
Almost half (33,000) are located within drug stores, grocery stores, hospitals, department stores, medical clinics, surgery clinics, universities, nursing homes, prisons, and other facilities.
Currently, more than 10,000 pharmacies nationwide are registered as CLIA-waived laboratories.4
Shifting the many tests and treatments for minor acute illness to the community pharmacy would relieve the burden on primary care providers.
“The results could be groundbreaking: increased patient and provider satisfaction. Patients get fast, affordable, on-demand diagnostics that traditional care models don’t offer. Physicians enjoy reduced burden, while pharmacists enjoy an expanded role.5
Walgreens, CVS, Walmart, and Rite Aid account for nearly 23,000 Pharmacies
CVS-Aetna merger: “Part of CVS’ advantage is the frequency at which patients use its services…Today, CVS engages 1 in every 3 Americans.”6
CVS’ 1,100 MinuteClinic® concept is underutilized… but CVS will be “increasing their use and expanding their scope of practice by adding new services for the treatment of chronic disease.”7
CVS’ MinuteClinic® will become community healthcare hubs where pharmacists would manage patients’ care and counsel them between primary care visits. 8
These walk-in clinics will serve as development labs for a much higher degree of automation in primary care than is currently available.9
Rite Aid merger with Albertsons now has a total of more than 4,300 pharmacies.10
Southeastern Grocers Partner with eTrueNorth to Launch CLIA-waived Laboratory Testing in 253 Local Pharmacies.11
The future looks bright for widespread adoption of infectious disease (remote testing) in pharmacies and other alternative testing sites in the future.12
- Use in Translational Research for assay development
- Build on Basic Scientific Research
- Clinical Research using validated assay
- Assay development
- Provide information for safety and effectiveness for use with a corresponding drug or biological product
- Deployable molecular diagnostic device
- Results comparable to laboratory-based molecular diagnostic technology