Developer Of First US OTC COVID-19 Antigen Test Plans 'Digital Diagnostics For Multitude Of Infectious Diseases'

Source : 'HBW Insight'

Earlier this year the Biden administration made a big bet on small Australian test maker Ellume Ltd. by giving it $231m to build a plant in the US to mass produce its OTC at-home antigen tests.

The test received an emergency use authorization (EUA) from the Food and Drug Administration in December and is touted as a key tool in the government’s arsenal to screen the population for the SARS-CoV-2 virus as it tries to reopen the economy.()

Ellume CEO Sean Parsons recently answered questions from Informa Pharma's Medtech Insight via email about next steps for the Ellume COVID-19 Home Test, and the firm more broadly:

What is Ellume doing to prepare for when the national public health emergency is over, and the EUA for the test comes to an end?

Sean Parsons: These are two great questions, ones that we expect to come up much more as vaccinations rise and case levels fall.
If the case load decreases, as we hope it will heading into summer, we expect that the most important use cases for the Ellume test will be for regular, proactive screening and testing when feeling ill. The choice to get tested when you are experiencing flu-like symptoms will be crucial over the coming months and could mean the difference between a waning crisis and a resurgence in the fall. 
We also expect to see hotspots emerge throughout the summer and into the fall and winter.
Ellume designed the test with digital connectivity in mind so that public health authorities can receive positive results in real time and contain the spread. This ability to capture and share information with authorities was one of the reasons why Ellume received the first EUA for a fully at-home COVID-19 [antigen] test.

Ellume CEO Sean Parsons: "We expect to see hotspots emerge throughout the summer and into the fall and winter."Ellume

 How did you come up with the idea for the test and how do you see it evolving?

Parsons: In the broader sense, Ellume does not aim to be an exclusive COVID-19 solution provider, but a leader in digital diagnostics for a multitude of infectious diseases. In fact, the Ellume COVID-19 Home Test stemmed from Ellume’s earlier work designing an at-home test for influenza.
When the pandemic hit early last year, Ellume paused its work in influenza and applied its core technology to the emerging pathogen, where the need was greatest.
Since its inception, Ellume has invested in the longer term need to better prepare for the increasing number of future pandemics. Its commitment to this long term vision is illustrated by its recent contract with the US Department of Defense to build its first US manufacturing facility in the US.
Accurate, accessible diagnostic solutions are a crucial tool in the fight against infectious diseases – not only to better empower patients but to help lift the burden from strained public health systems.
Ellume was prescient in predicting this need, and believed that consumers would benefit from having more control and understanding around their own health.
We’ve seen this trend start to play out over the past year. As in many industries, the pandemic has accelerated innovation within the healthcare industry, as well as consumer behavior. The past year has seen the rise of telehealth and improved options for remote patient-physician interaction, as well as greater consumer literacy around the value of digital diagnostics. This is one of the major behavioral changes Ellume expects to come out of the pandemic – a greater demand for over-the-counter diagnostics tools. After the current crisis fades, we expect a continued expectation for this level of access and control over one’s health.

Are you looking to get your test cleared for the US market after the EUA runs out?

Parsons: In terms of regulatory status, the company is confident following further post-authorization studies, that it will secure full FDA clearance for the Ellume COVID-19 Home Test when the initial EUA is terminated.  
Ellume’s core technology was developed over the course of a decade, combining a groundbreaking digital assay with next-generation optoelectronic detection software to create highly accurate and affordable digital diagnostics. This unique technology enables the high sensitivity and specificity seen within its COVID-19 Home Test. 
In fact, the test demonstrated an overall sensitivity of 95% (positive percent agreement) and specificity of 97% (negative percent agreement) when compared to an emergency use-authorized RT-PCR laboratory test. In individuals presenting with COVID-19 symptoms, the Ellume COVID-19 Home Test demonstrated a sensitivity of 96% and specificity of 100%, and in asymptomatic individuals, the test demonstrated a sensitivity of 91% and specificity of 96%.

What other applications is the company looking to use this technology for and is it preparing premarket applications to the FDA for those?

Parsons: Ellume applies the same core technology from within its COVID-19 Home Test across its other diagnostic products. This technology can be scaled across a number of pathogens, including tuberculosis and influenza, and can be adapted to new pathogens that may arise in the future.
It is in the process of preparing pre-market applications to the FDA for a number of products, including an at-home, over-the-counter influenza test and two new COVID-19 tests for use by clinicians at the point-of-care. One is for the detection of antibodies to COVID-19 to demonstrate past infection and the other is a COVID-19 antigen test for current infections.“Once completed and running at full capacity, the [US] facility will be able to produce up to 19 million tests per month and bring Ellume’s total production close to 1 million tests per day. In the future, this facility will help the US prepare for, and react quickly to, future threats from infectious disease.”   Additionally, the QIAreach QuantiFERON-TB product pairs Ellume’s ultra-sensitive technology with a complete testing workflow designed for cost-efficiency and ease of use. In partnership with QIAGEN, this product is focused on detection of tuberculosis in field settings for public health use, and has the ability to perform eight tests simultaneously, with early positive results in as few as three minutes. Prior to the onset of COVID-19, tuberculosis was the number one infectious disease killer globally, causing 1.4 million deaths in 2019.

Is Ellume facing any supply chain issues with producing enough tests, and if one day there is another pandemic and supply chain problems, is the company thinking about how to address that?

Parsons: There continues to be a global supply chain challenge in the medtech and health care industries that every manufacturer is facing, and our supply chain is no exception. While the maximum production capacity of Ellume’s existing Australian facility is about 200,000 tests per day, we are currently ramping up to this number as our supply chain restraints are resolved. 
We have worked very closely with our network to mitigate the challenges of delays in the supply chain and are now in a strong position to accelerate our manufacturing ramp-up. Early on in the pandemic, we worked alongside the US government to help diversify our supply chain and bring on new vendors in the anticipation of delays. Today, the Defense Production Act is being leveraged to allow greater access to important materials. 
Ellume recently signed a contract with the US government to supply 8.5 million COVID-19 Home Tests, and invest in our first US-based manufacturing facility, which will enable us to further increase our production capacity and better prepare for future pandemic scenarios.
Once completed and running at full capacity, the facility will be able to produce up to 19 million tests per month and bring Ellume’s total production close to 1 million tests per day. In the future, this facility will help the US prepare for, and react quickly to, future threats from infectious disease. We know that the lack of early, accessible, rapid testing exacerbated the spread of the COVID-19 pandemic, and it is our goal to help people, communities and governments better tackle infectious disease in the future.

By Ferdous Al-Faruque