Bioluminescent Molecular Diagnostics Platform Enables Rapid On-Site Pathogen Detection

Every year, an estimated 600,000 people die from malaria, with over 95% of those deaths occurring in sub-Saharan Africa. In these regions, diagnostics are often lacking, and patients may be treated without accurate knowledge of their condition. This leads to unnecessary antibiotic use, heightening the risk of antibiotic resistance and worsening patient outcomes. Existing methods either rely on sensitive but laboratory-dependent PCR technology or on simple, low-cost antigen tests that lack accuracy. Now, researchers have developed a new test that combines the sensitivity of PCR with the simplicity and speed of rapid tests, enabling accurate pathogen detection even outside the lab environment.

The new diagnostic solution was developed by Spotlight Dx (Bunnik, Netherlands), a startup founded by researchers from Eindhoven University of Technology (Eindhoven, Netherlands), along with collaborators. The platform, initially conceived during the COVID-19 pandemic, leverages CRISPR-Cas9 technology to detect DNA from pathogens with high specificity. The Cas9 proteins are linked to luciferase enzymes, which emit light when the target DNA is identified. This bioluminescent signal can be read by a simple device, such as a smartphone camera, eliminating the need for complex lab equipment. Unlike traditional PCR, the system uses a DNA amplification method that works at a constant low temperature, making it faster and more field-friendly. The test was first validated during the COVID-19 pandemic, and the results published in ACS Central Science showed comparable accuracy to PCR but with a significantly faster turnaround.

Since then, the test has been applied on a small scale to samples of patients with sexually transmitted infections and is now being prepared for field validation in Uganda, focusing on malaria. The technology has demonstrated promise in distinguishing between infections that exhibit similar symptoms but require different treatments. The startup has also applied the test on a small scale to samples from patients with the common STIs, gonorrhea and chlamydia. They developed color-variant readouts, such as blue light for chlamydia and green for gonorrhea, to facilitate simultaneous detection of multiple infections. The team is also working on establishing local manufacturing capacity in countries with the greatest need to ensure accessibility and sustainability. Spotlight Dx has forged partnerships with universities and research centers in Uganda, Rwanda, and Burkina Faso, aiming to establish validation studies and build diagnostic capacity locally. The next steps include scaling production, validating the malaria test in real-world settings, and expanding the test's applications to cover more pathogens across various healthcare systems.

“Our test is right in the sweet spot between the two,” said Spotlight Dx co-founder Harm van der Veer. “It focuses on DNA, is almost as sensitive as PCR, but is faster and much easier to use—even outside the lab. In principle, a simple smartphone camera is all you need to read the light emitted by the test.”

“We are starting with the development and production of the test kits in the Netherlands, but ultimately want to move production to the countries where the need is greatest. This will ensure that the technology remains accessible, affordable, and sustainable—even without foreign aid,” added van der Veer.

Related Links:
Spotlight Dx
Eindhoven University of Technology