Diagnostic Technologies

Noncommunicable Diseases Portfolio

Disease overview

While the impact of infectious diseases understandably attracts significant attention and funding from the global health community, noncommunicable diseases (NCDs) such as diabetes, cancer, heart disease, and HPV are also responsible for significant morbidity in the developing world. As the effects of major infectious diseases are incrementally reduced, NCDs will inevitably become more prominent global health problems. Even today, 60% of all deaths worldwide are due to chronic disease, primarily in low- and middle-income countries.

In 2011, for example, there were 366 million people living with diabetes, and this number is estimated to grow to 552 million by 2030. The majority of these people live in low- and middle-income settings, and 50% of those worldwide are unaware of their disease status. The world faces a rapidly growing population of both diagnosed and undiagnosed diabetics in low-resource settings (LRS).

Portfolio goals

The Diagnostic Program’s NCD portfolio has projects in diabetes, gestational diabetes mellitus (GDM) screening and monitoring technologies, preeclampsia, and breast cancer and kidney function assays. In addition, the Diagnostics Program has established cross-program partnerships with PATH’s Reproductive Health and HIV/TB Global Programs relating to sustainable diabetes care delivery and tuberculosis (TB) /diabetes cross-screening activities.

Areas of focus

Technologies for diabetes screening and diagnosis

Currently, LRS appropriate tools for screening and diagnosis are lacking or limited, including most risk-scoring systems. For example, many approaches require fasting. Better tools for actionable diagnosis are needed and will play a vital role, if preventative treatment solutions appropriate for LRS are also made available. Contributions in this area will be incremental as existing methods for screening do exist; however, given the scale of the problem, even an incremental improvement would have tremendous impact.

Diabetes treatment efficacy monitoring

Assays for glucose monitoring and treatment management assays are required for any insulin treatment and are also useful in other treatment and prevention efforts. The expense of daily blood glucose monitoring and the cost and limitations of existing treatment monitoring tools are key bottlenecks for treatment.

Meanwhile, clinicians face an information barrier due to the limitations of current technologies for monitoring treatment efficacy. Many diabetics in low-resource settings can only access health care infrequently, yet available diagnostics provide only a snapshot of glucose control and fail to record clinically relevant trends.

Evaluation of new/emerging diabetes screening technologies

PATH will develop specific proposals for evaluations of LRS-compatible diabetes technologies. PATH has recently been awarded funding from the Medtronic Foundation to establish a Center for Diabetes Technology in Low-Resource Settings; these funds will be a critical catalyst for this work.

Development of rapid test for GDM screening using glycated albumin

A new marker, glycated albumin, has been identified that could allow non-fasting, low-cost screening for GDM in antenatal care settings. Current work at PATH aims to develop a rapid test for this marker. Further work will clarify that the test will be sufficiently accurate and predictive to be used without an instrument. After a round of internal funding, this project was recently awarded a Saving Lives at Birth grant from the United States Agency for International Development.

Development of a device for glycemic control monitoring

The goal of this project is to develop a low-cost, point-of-care device that can be used for diabetes screening as well as glycemic control monitoring in a wide range of clinical settings. It would measure several parameters (including blood glucose, A1c, glycated albumin, and potentially other markers) correlated to hyperglycemia at different timescales and glycemic variability) and also provide redundancy by providing multiple indicators of glycemic control to identify patients for whom A1c screening is ineffective.

Regional and co-morbidity-specific diabetes risk scores

Diabetes risk scores generally combine biometric measurements such as a weight, waist circumference, and a body mass index rating) measurements with a number of health history questions and are a low-cost, effective predictor of diabetes risk. Historically, many different diabetes risk scores have been developed, but these have not been evaluated for LRS populations. PATH aims to analyze existing risk scoring mechanisms and adapt them to the identified needs of LRS populations.

Breast cancer diagnostics and screening

Two projects related to breast cancer in low-resource settings are under way. The first involves the detection of specific hormone receptors in breast cancer patients to determine eligibility for treatment with tamoxifen and the other to identify appropriate lower-cost biopsy techniques for the diagnosis of palpable breast masses.

Tuberculosis/diabetes cross screening

An initiative assessing the suitability of novel point-of-care devices to screen for diabetes among people with TB and for TB among people with diabetes is under way. Diabetes triples the risk of developing TB, and rates of TB are disproportionately higher in people with diabetes. PATH is conducting this study in partnership with the Mexican Ministry of Health and will also aim to identify risk factors in both populations.