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When we go to the doctor, it's safe to say that most of us want to know three things as soon as possible: if we're actually sick, what we're sick with and how to best treat it. Unfortunately, in-office diagnosis isn't either fast nor all that accurate, sometimes leading to people getting prescribed drugs they don't need.
Lumos Diagnostics is a company helps develop and manufacture custom rapid point-of-care (POC) diagnostic solutions to help doctors diagnose viral infections in-office. The company, originally a spinout from Australian technology commercialization company Planet Innovation, merged with RPS Diagnostics in May of last year to launch the FebriDx test, which provides clinicians with an in-office assessment of the body’s immune response to acute respiratory infection (ARI).
The FebriDx test takes only 10 minutes, can be done during an outpatient visit meaning in a general practice, pediatrics, urgent care and retail health, and can identify a "clinically significant acute respiratory infection and differentiate viral from bacterial infection," Sam Lanyon, chairman of the board for Lumos Diagnostics and co-chief executive officer for Planet Innovation, told VatorNews.
"Most clinicians rely on clinical symptoms and signs. Unfortunately, viral and bacterial respiratory infections can be challenging to differentiate because of their overlap in clinical presentation. This often leads to clinicians to prescribe unnecessary antibiotics to reduce their diagnostic uncertainty," he said.
"The diagnostic result provides a key answer to the source of the infection and a clear next step for the healthcare practitioner i.e. prescription of antibiotics or not. Other tests in common use tend to be pathogen specific and therefore look for a specific bacteria or virus (such as rapid Strep or Flu tests). Whilst these pathogen specific tests can be useful, they are better suited as down-stream diagnostic options once the infection is better characterized."
On Wednesday, the company announced that it raised a $15 million U.S. Series A round of funding from Planet Innovation, which will be used to expand internationally.
There are two sides to the Lumos business, Lanyon told me. The first is its pipeline of branded diagnostic tests that target the host immune response, such as the FebriDx test. The company also has a service business to help its customers develop and manufacture their own custom, rapid point-of-care diagnostic solutions, including an electronic reader technology that enables Lumos to digitize lateral flow tests.
"Offering this service enables us to help make point-of-care testing more accessible, directly where it’s really needed," said Lanyon.
In addition to being able to diagnose patients quicker, the FebriDx test is also highly accurate; it has a 97-99 percent negative predicative value in ruling out bacterial infection, meaning that when the test result tells the doctor to not prescribe antibiotics, they can be certain that they are doing the right thing for the patient.
"Acute respiratory infection is the most common reason for both outpatient office visits and antibiotic prescriptions. Up to 80 percent of all antibiotic prescriptions originate from primary care settings and 60 percent of those prescriptions are for acute respiratory infections. Because the FebriDx test identifies a host immune response to a clinically significant infection, clinical management and therapeutic decisions can be targeted to patients with a bacterial infection who will thus benefit from antibiotics," Lanyon explained.
"Antibiotics are ineffective in patients with viral infection. By limiting unnecessary antibiotics, the cost of the antibiotics themselves, the cost of antibiotic-related adverse events including rash, gastrointestinal distress and anaphylaxis as well as secondary infections like C. difficile colitis can be reduced. Moreover, showing the FebriDx test result to patients can often limit unnecessary follow up visits."
Lumos has focused the initial launch of FebriDx in Europe, where the company now has multiple ongoing, country-specific institutional outcome studies. It also has dozens of general practitioners who have participated in its GP Quick Start program, which allows those doctors to formally try the FebriDx test in their office free of charge.
The company will use the new funding to facilitate international expansion of the FebriDx test into other markets with regulatory approval, including Canada, Singapore, Pakistan, and Australia. Lumos also hopes to have FDA trials in the U.S. done this year.
"The need for a rapid test that differentiates viral from bacterial infection is global. Thus, market expansion decisions are largely driven by market size and need, regulatory approval timing and a path towards test reimbursement or government payment," said Lanyon.
The belief driving Lumos is that healthcare will continue to go more in the direction of the consumer, with an emphasis on quality, convenience, personalisation and connectedness.
"Planet Innovation’s goal is to invest in commercially successful solutions which tackle global problems. Lumos Diagnostics not only shares these values, they are demonstrated day-in and day-out through the products and services we provide in healthcare. FebriDx is a great example, it is a game-changing test to help triage patients with bacterial and viral infections which has global significance when considering the impact of pandemics such as Novel Coronavirus," said Lanyon.
"Ultimate success for Lumos is achieving a scale which not only allows the use of the extensive IP portfolio to tackle specific global healthcare problems, but it also allows us to work our commercial partners to help them achieve the same."
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