Lumos Diagnostics Limited receives US-FDA Clearance for FebriDx POC Test
Australia:
On 3 July 2023, Lumos Diagnostics Limited have announced that they have
received approval for FebriDx POC test to identify bacterial acute respiratory
infection. The test entails the use of an immunoassay on a finger prick blood
specimen to offer concurrent, qualitative assessment of increased amounts of
C-reactive protein (CRP) and myxovirus resistance protein A (MxA). FebriDx POC
test utilizes an innovative dual biomarker technology to quickly determine
whether an infection is caused by a virus or bacteria. The approval permits
FebriDx to be marketed in the United States for utilization by medical
practitioners as a tool in identifying acute respiratory infection. Moreover,
it is intended to be used in conjunction with clinical indications and
symptoms, along with other clinical and laboratory discoveries. FebriDx is
currently authorized in the UK, Europe, Canada, UAE, Brazil, Turkey, Pakistan,
Singapore, Malaysia, and Australia.
The
improper and redundant prescribing of antibiotics is acknowledged as a
significant contributing factor to the increasing worldwide emergence of
antimicrobial resistant (AMR) strains of bacterial pathogens. In 2021, US
healthcare professionals practicing in non-hospital settings wrote 211 million
antibiotic prescriptions, accounting for 636 prescriptions per 1,000
individuals. Although acute respiratory infections are mostly caused by
viruses, they are the most frequent reason for prescribing antibiotics, and
around 40% of these prescriptions are considered unnecessary. To conquer this
issue Lumos Diagnostics filed a new 510(k) submission for FebriDx POC test to
the FDA in earlier 2023. On 3rd July FDA concluded its evaluation
and determined that FebriDx test has shown significant similarity to the
reference device mentioned in this application.
According to the CEO of Lumos Diagnostics Limited, “We are delighted to finally secure clearance to market
our FebriDx rapid, point–of–care test in the US as we continue to believe it
has an important role to play in antibiotic stewardship. It is a credit to the
Regulatory team at Lumos that we have been able to deliver this outcome from
our new 510(k) application significantly ahead of our initial expectations.
With this clearance in hand, we anticipate securing our first commercial orders
in the US before the end of calendar year 2023. In the meantime, we are
continuing to work with distribution partners and potential licensees, as well
as establish our own focused sales effort, as we prepare to launch FebriDx in
the US.”
According to TechSci
Research, The combination of innovative strategies and new product launches have
consistently emerged as remarkable approaches to achieve technological
advancements in the global healthcare system. Point-of-care testing (POCT) is a
rapidly expanding diagnostic tool that offers a swift test outcome for
immediate clinical decisions. However, clearance of FebriDx POC test have
upgraded the portfolio of Lumos Diagnostics Limited which specializes in rapid
and cost-effective point-of-care diagnostic testing technologies. Moreover, the
company excels in developing and marketing innovative Lumos-branded POC tests
that focus on infectious and inflammatory ailments. The clinical performance of
the FebriDx examination has been assessed in two ongoing multicenter clinical
trials in the United States. Consequently, the FebriDx test exhibited a notable
level of accuracy in diagnosing patients with clinically significant bacterial
and viral acute respiratory infections.