Press release

Lumos Diagnostics and RPS Diagnostics Merge to Create Full Service Development Company and Support International Commercialization of FebriDx

Sponsored by Businesswire

, a California-based full-service point-of-care (POC)
diagnostic development company and previous spinoff from Australia-based Planet
and RPS
, a Florida-based commercial diagnostic developer,
manufacturer, and marketer of POC diagnostic tests, announced today that
they have merged. The combined company will be called Lumos Diagnostics.

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FebriDx Test (Photo: Business Wire)

FebriDx Test (Photo: Business Wire)

Lumos Diagnostics’ initial focus is on the international launch of the
FebriDx® test, a rapid, in-office POC test that incorporates a built-in
safety lancet to obtain a fingerstick blood sample, rotating blood
collection and transfer system, and integrated push-button buffer
activation, to provide clinicians with a rapid assessment of the body’s
immune response to an acute respiratory infection (ARI). The single use
test identifies patients within 10 minutes that have a clinically
significant underlying infection and aids in the differentiation of
viral and bacterial ARIs through the simultaneous detection of both
Myxovirus resistance protein A (MxA) and C-reactive protein (CRP)
directly from peripheral whole blood. MxA is an intracellular protein
that becomes elevated in the presence of acute viral infection and CRP
is an acute-phase inflammatory protein that is elevated in the presence
of clinically significant infection.

Sam Lanyon, chairman of the board for Lumos Diagnostics states, “We have
evaluated many technologies over the years, and believe that combining
RPS Diagnostics’ novel biomarker technology and commercial experience
together with Lumos Diagnostics’ reader-based platform results in a
highly strategic and synergistic union that will support a robust
pipeline and commercial success.”

ARI are often highly contagious and result in more than half of all
antibiotics that are prescribed for outpatient primary and urgent care
visits. ARIs may be associated with nonspecific flu-like symptoms,
including fever, sore throat, cough, nasal congestion, and fatigue.
Bacterial infections pose the highest risk of morbidity and are the only
infections that benefit from antibiotic treatment. Diagnostic
uncertainty from overlapping ARI symptoms and signs combined with
patient or parent pressures for antibiotic prescriptions lead to more
than 50% of all unnecessary antibiotic prescriptions. Rapid single
pathogen tests, such as for Strep A and Influenza, cannot differentiate
colonization from true infection and are indicated for only specific
respiratory conditions, accounting for about 15% and 25% of patient
visits, respectively; whereas the majority of the patients have other
viral infections, bacterial infections, or a microbiologically
unconfirmed respiratory illness.

Clinical performance from two prospective multi-center U.S. clinical
trials demonstrate the FebriDx test’s high accuracy and 97-99% negative
predictive value to exclude a bacterial infection. Moreover, in a small
United Kingdom outcome study, FebriDx was shown to alter clinical
management decisions in 48% of patients tested and reduced unnecessary
antibiotic prescriptions by 80%. By enabling a rapid diagnosis at the
initial office visit, the FebriDx test may help to limit the amount of
unnecessary antibiotic prescriptions that can lead to avoidable adverse
reactions and antibiotic resistance, resulting in lower costs.

Robert Sambursky, MD, the president and chief executive officer of RPS
Diagnostics, who will continue in the same role for the joint Lumos
Diagnostics entity states, “Using FebriDx to help triage outpatient ARI
is a game changer because successful antibiotic stewardship requires the
clinician to first rule out a clinically significant bacterial
infection. In addition, access to novel Lumos Diagnostics reader
technology will facilitate next generation digital enhancements which
will accelerate speed to results, allow for quantitation, and enhance
objectivity of our branded product lines.”

Lumos Diagnostics

Lumos Diagnostics provides rapid, cost effective, and complete
point-of-care (POC) diagnostic test solutions that utilize proprietary
digital reader platforms to help healthcare professionals more
accurately diagnose and manage diseases and medical conditions. Lumos
provides assay development and manufacturing services for customized POC
tests as well as directly develops, manufactures, and will commercialize
a suite of Lumos-branded POC tests. Conditions targeted by Lumos tests
include infectious and inflammatory diseases with unmet diagnostic
needs, including fever, biological threats, and infectious disease,
resulting in less unnecessary treatments with associated adverse events,
reduced spread of disease, and more effective antibiotic stewardship

The FebriDx test has received Health Canada approval, Saudi FDA
clearance, Singapore Health Sciences Authority registration, and is CE
marked for sale in Europe. At this time, the FebriDx test has not
received U.S. Food and Drug Administration (FDA) clearance and is not
commercially available in the United States. For more information on
Lumos Diagnostics, visit,
and for more information on FebriDx, visit