A Journey of Innovation and Vision – The Mawi Story of Resilience

A Journey of Innovation and Vision – The Mawi Story of Resilience

Mawi was founded with one major goal: to simplify sample collection, transportation, and storage while making the process as painless as possible, especially for babies and the elderly. The collected samples are not only designed for ambient-temperature transport but also built to withstand a wide range of temperature changes during transit.

When iSWAB-DNA was introduced in 2014, our objective was to leverage existing collection technology—The swab—while significantly improving its functionality. Our colleagues informed us that breaking the swab head into the tube for lab processing posed two major operational challenges:

• Sample processing with automation
• DNA quality: fragmented and low yields, often requiring re-sampling

In response, we developed the swab-free sample collection technology we call iSWAB®. This innovation stabilized the sample at the point of collection by mechanically removing the sample of the swab head into a proprietary stabilizing buffer. This feature allowed collected material from multiple swabs to be combined within the same tube to concentrate the sample highly if needed. After collection, the swabs are discarded rather than sent back. The collected samples would arrive at the lab swab-free, simplifying processing. Initially, we focused on human DNA collection for direct-PCR applications for STR profiling, which do not require extraction or genotyping. However, we anticipated the evolving landscape of genotyping by microarray and the rise of more complex, comprehensive genetic assays utilizing next-generation sequencing. As a result, we added two critical features to keep pace with advances in genomics:

• High-quality, high molecular weight, double-stranded genomic DNA
• Significant reduction of bacterial DNA contamination

These features not only enhance human DNA sequencing coverage but also make the technology ideal for both short- and long-read sequencing technologies.

One of the core principles at Mawi is, “If we can’t make something better, we don’t touch it.” We applied this principle to advance iSWAB technology for other molecular biology needs. One key question that surfaced was: How can we maximize the recovery of multiple analytes from a single sample or subject while making the process as painless as possible?

Our first attempt was with iSWAB-Microbiome, designed to stabilize both microbial DNA and RNA from the same sample at the point of collection while at the same time preserving microbial representation from highly abundant to low-abundance organisms, including viruses. The technology was rigorously tested during the COVID-19 pandemic across multiple microbiome cohorts, including gut, skin, oral, and vaginal, in addition to soil and water. The pandemic resulted in shortages of viral RNA extraction reagents and swabs. Recognizing this, we optimized our microbial DNA and RNA stabilization formulation to eliminate the need for microbial DNA/RNA

extraction, addressing shortages and significantly improving sample-to-result turnaround times. The result was the launch of iSWAB-Microbiome-EL and its FDA 510(k)-cleared counterpart, iSWAB-RC-EL (EL for Extraction-Less); throughout the pandemic, these products were field-tested on millions of patients worldwide for collection of COVID-19 and other infectious disease samples.

We introduced new swabs with a novel fiber-free head concept to tackle swab shortages. Our NextSwab (6-inch) and BioWand (3-inch) are fully molded polypropylene swabs designed for comfort and scalability. The design of each swab head features inner channels that capture and retain samples, which can be fully released upon contact with the stabilizing buffer inside the tube. This innovation enables swab-free sample delivery and can be easily scaled to meet surges in need or demand.

Continuing our mission to maximize outcomes while minimizing discomfort, we developed iSWAB-Cells, a noninvasive sample collection system for OMICS applications. iSWAB-Cells enables researchers to capture intact cells, genomic DNA, RNA, and cellular protein markers from the same sample. This tool has proven invaluable for researchers at the Mayo Clinic studying cardiomyopathy.

Recognizing that not all answers can be obtained from the swab-based collection, we turned to blood samples —blood holds significant clues to health and wellness. HemaSure-OMICs were specifically designed to stabilize gDNA, RNA, cfDNA, and plasma protein markers from whole blood at ambient temperature. This technology has been instrumental in the early detection of kidney transplant rejection, reducing the required blood volume from 15 mL to just 6 mL. HemaSure-OMICs have also been extensively utilized for HIV surveillance and viral load testing in Africa, further expanding their utility. It is available in vacuum-filled tubes for 3, 6, and 9 mL with a newly introduced HemaSure-BD for blood drop collection option for at-home or field-based whole blood collection.

At Mawi, innovation is ongoing, driven by the outstanding support of our fellow researchers and their invaluable feedback. Our current focus is on helping communities with unreliable power grid infrastructure gain access to healthcare through efficient and robust human, animal, and environmental sample collection.