While COVID has most certainly been top-of-mind for companies working to combat infectious disease, we must not forget the other microbes out there that are still cause for concern.

Tuberculosis (TB) is a prime example. Most have heard of this disease, but probably in the context of their history classes. You might be surprised to hear, then, that tuberculosis caused an estimated 1.5 million deaths in 2020, making it second only to COVID as the leading cause of death due to an infectious agent.

And this wasn’t just a one-off trend in 2020, mind you. Tuberculosis has been a leading cause of death for many, many years prior, switching spots back and forth with HIV as the #1 infectious disease killer.

If these statistics surprised you, you’re not alone. While TB isn’t considered a cause for major concern in developed nations, in underprivileged nations this disease runs amuck.

There are many reasons for this. First, the bacterium that causes TB disease, Mycobacterium tuberculosis, is one hardy little bugger. The bacteria are unique in that they have a very thick, waxy cell wall, which makes it harder for an antibiotic to pass through. Even more frustrating, the bacteria rallies our immune system in such a way that it becomes surrounded and further protected in the lungs by our own cells and other materials in a structure called a granuloma.

This means that we need to hit full throttle with an antibiotic cocktail to treat the disease, with these antibiotics having less-than-desirable side effects and requiring long treatment times.  For those in less privileged countries, these factors alone make compliance a major issue, but the COVID pandemic has only compounded the difficulties in receiving TB treatment.

The other major factor, and one that Ellume and QIAGEN are actively working to combat, is accessibility to sensitive, accurate testing. If the COVID-19 pandemic has taught us anything, it’s the importance of accessible, quick, and easy testing to mitigate disease spread. The “gold standard” in TB testing is a QuantiFERON test, which measures levels of interferon-gamma, a cytokine that plays a major role in the immune response against TB, in the patient’s blood.

The challenge in many low-resource, high-burden countries is the lack of access to such diagnostic tests due to limited support infrastructure, including few large centralized laboratories.  This lack of access dramatically impacts progress towards the World Health Organization (WHO) goal to end TB by 2030.

This is where the Ellume / QIAGEN partnership comes into play.

In 2019, Ellume announced its global partnership with QIAGEN to make testing more accessible by developing a new version of the QuantiFERON test, called QIAreach™ QFT. This technology, which is about half the size of a laptop and battery-operated, combines Ellume’s ultrasensitive digital detection technology with a complete testing workflow that can test up to eight samples simultaneously. Further, it can detect active infections as well as latent infections before progression to illness and further spread.  This early detection can allow for the correct measures and treatments to be applied and increase the effectiveness of TB programs.

Being able to detect latent infections is especially important, as TB bacteria are like a ticking timebomb that can be set off by other infections, such as HIV, or other factors such as becoming immunocompromised.  The sooner one can test and intervene, the better.

Of course, development and optimization of QIAreach™ QFT took a bit of a backseat when COVID made its grand debut just a year later, but the teams continued onward.  It helps that QIAGEN has a subsidiary location in Germantown, Maryland, just a short drive down I-270 from the new Frederick-manufacturing base being established for Ellume.  This past January marked a major milestone as the companies were thrilled to announce that the product received approval to launch to more than 100 countries with limited infrastructure.

So what are the next steps for Ellume and QIAGEN?

“Now it’s about the QIAGEN team using its global commercial reach to deploy these units into the areas in the world that need them, and we’re looking to increase our manufacturing operations in the coming months to support them,” said Jeff Boyle, President of Ellume USA, in an interview with BioBuzz. “We’re also looking forward to continuing to grow our partnership with QIAGEN, a leader in the diagnostics space, as well as continuing to build the capacity of our U.S.-based manufacturing of Ellume’s OTC Home COVID tests in our partnership with the Department of Defense.”