PreQuine: Reduce Inefficiencies in Malaria Testing

G6PD deficiency affects anywhere from 5-30% of the population. A deficiency of G6PD can lead to hemolytic anemia. In malaria endemic regions, effective treatments such as primaquine or tafenoquine can induce additional hemolysis which, for patients with a G6PD deficiency, can lead to life threatening complications. In order to decide confidently whether a patient can receive these drugs, G6PD status must be confirmed. G6PD determination previously required travel to a clinic, a venous blood draw, and laboratory analysis which produced substantial amounts of waste, inefficiencies, unnecessary travel, and extended turnaround times. This created a problem aligning with the 2023 Horizon Prize as 1) it generated a significant carbon footprint and 2) it did not meet the patients' needs. IVDS created PreQuine as a point-of-care assay that can determine G6PD status and measure hemoglobin (Hb) in less than 60 seconds with only 10uL of blood from a finger or heel stick sample, using a kit that minimizes waste, i.e. plastic packaging.

PreQuine is a mobile assay with minimal and self-contained consumable supplies that retains a high testing throughput and substantially lowers the requirement for travel, shipping, packaging, and waste. Most notably, the PreQuine system comes with a self-contained blood sample collection and diluent tube which reduces the need for multiple consumables in obtaining and testing blood samples.

This test will significantly reduce the burden on patients and healthcare providers in malaria endemic regions, especially remote regions with limited access to care. Actionable results will drive effective decisions making in terms of treatment strategies (i.e., primaquine or tafenoquine) on a rapid, patient-by-patient basis.

The mission of IVDS is to create scientific solutions to improve the quality of life through timely, accessible, and actionable diagnostic information. We envision a world where individuals can take control of their health with personalized data and insights obtained anytime, anywhere. Thus, we aim to create point-of-care diagnostic platforms in which multiple biomarkers can be detected, measured, and monitored, with a focus on affordability, speed, portability, and remote dissemination of data. With this mission, IVDS has been a pioneer within the space developing a number of point-of-care tests for historically underserved conditions, including phenylketonuria, G6PD deficiency, long-chain fatty acid oxidation disorders, and deficiency of adenosine deaminase 2. Besides our more than 30 years of extensive technical experience, 10 commercial products, over $US7 million in NIH funding, 18 successful Small Business Innovation Research (SBIR) awards, and 6 patents, the true key to IVDS’s continued success is in our relationships with patients and caregivers. We have developed and maintained these key stakeholder relationships over the years in order to hear directly from them about what they need, how we could help, and what steps we need to take along the way. For example, IVDS has frequent team meetings with representatives of patient advocacy groups (The National PKU Alliance, Homocystinuria Network America, and the DADA2 Foundation), clinicians and experts, and patients and caregivers directly before and during the development of our tests. IVDS has three sites for clinical studies using PreQuine Platform scheduled to begin in Q4 2023.

IVDS has an injection molded plastic meter design (I.F. Associates Inc., Allenwood, NJ) with PCBs (TouchPad Electronics, Mukwonago, WI) and LED array with final assembly occurring in-house. Test strips are manufactured in-house in a <25% humidity manufacturing space with a Yasui Seiki Mirwek automated coating system, custom slitter and membrane welder (Azco Corp., Fairfield, NJ), and a semiautomated process for assembling and singulating test strip cassettes. We have a PreQuine platform mobile app that connects with meters via Bluetooth, supports Patient ID entry, walks users through sample collection and directions of use, and reports a calculated Hb level (g/dL) and G6PD activity (U/dL) and calculated U/g Hb based on the received reflectance (%R) values from the meter with a stored test history.

The initial funds from Solve will be used to supplement the ongoing operations of IVDS, such as completion of clinical studies, FDA 510k submission, and marketing of the platform. Furthermore, IVDS seeks the invaluable connections that the MIT Solve network provides. The core values at IVDS include a focus on patient-centric solutions, and this lines up well with the Solve core values such as optimism, inclusive technology, and human-centered solutions. We will benefit greatly from becoming part of the Solve network and, likewise, we anticipate that our goals and experience can be of great value to others within Solve. Specifically, IVDS seeks technical and logistical support for developing a web-based personal health dashboard that consolidates information from the PreQuine platform mobile app to provide informational visualizations, health assessments and/or suggestions, actionable health trend identification at the population level (e.g., to spur governmental action), and supports high impact longitudinal studies over time.

The Founder and President of IVDS, Robert Harper, has dedicated his career to support the quality of life of individuals suffering from serious diseases. Since its inception IVDS has received over $8 million in funding from the NIH (who continue to support our mission) and 18 SBIR grants to develop novel, point-of-care diagnostic tests for rare metabolic disorders and globally challenging conditions. The success of this work is mainly driven by the close relationships IVDS has built with patient advocacy groups and direct communication with patients and their families. IVDS collaborates with experts in public health in globally underserved countries such as Kenya, Mongolia, and Haiti (Bernard Okech, Uniformed Services University of the Health Sciences, Bethesda, MD and Michael von Fricken, George Mason University, Fairfax, Virginia). IVDS also recently received an award form the state of New Jersey for continuation of work to improve maternal health (the NJ CSIT Maternal and Infant Health R&D Grant Program).