NetworkNewsWire
Editorial Coverage: As surging rates of infection ripple across
the United States and other parts of the world, many are waking up
to a new reality: the beast is not fading away.
Governments are ramping up precautions as cases of the
current global health crisis rise to new heights in parts of
the US and around the world—potentially wiping out two months of
progress. There were 34,700 cases reported July 7, bringing the US
close to its late-April peak of 36,400 new cases in one day,
according to a count
kept by Johns Hopkins University. Worldwide, more than 10
million people have been infected and over half a million have died
from the current crisis. In the US, there are over 2.7 million
confirmed cases and 128,496 reported deaths. More than 25
million Americans have been tested for the virus, fueling an
ever-increasing demand for efficacy and mass-production in testing
capabilities. According to infectious disease experts, there will
be recurring outbreaks without more robust testing, contact
tracing, and quarantine services across the country.
LexaGene Holdings, Inc. (TSX.V: LXG) (OTCQB:
LXXGF) (LXG
Profile), Co-Diagnostics Inc. (NASDAQ:
CODX), and Abbot
Laboratories (NYSE: ABT) are working
to create fast and accurate tests, while drugmakers Moderna (NASDAQ:
MRNA) and Novavax
Inc. (NASDAQ: NVAX) are focused on
delivering a plausible vaccine to the wanting market.
Click here to view the
custom infographic of the LexaGene Holdings Inc. (TSXV:
LXG) editorial.
Testing and Tracing Essential for Reopening
The daily number of new cases in the US continues to
rise, causing several states to slow down reopening plans. The
US has now conducted more tests than any other country, but it’s
evident that ongoing testing and contact tracing is essential. The
FDA has issued Emergency Use Authorization (EUA) to 157 potential
tests, including 132 molecular tests, 24 antibody tests, and one
antigen test, and continues to evaluate more potential candidates.
Biotech company LexaGene (TSX.V: LXG) (OTCQB:
LXXGF) (LXG
Profile) is currently moving
through the EUA process to get its MiQLab pathogen detection
device added to that list.
LexaGene’s MiQLab genetic analyzer is capable
of quickly and accurately detecting multiple pathogens, including
the presence of the SARS-CoV-2 N-gene RNA, in contrived respiratory
samples. Unlike most of the other testing solutions being used,
which only look for signs of the current virus and have a
significant false-negative rate, LexeGene’s analyzer screens for
multiple pathogens at once, including the current virus, influenza,
adenovirus, RSV, metapneumovirus, and seasonal coronavirus.
LexaGene has automated the entire workflow in an instrument
designed to be placed at the point-of-need. It takes less than one
minute of hands-on time to initiate sample processing for walk-away
testing.
Technology Delivers Critical Feedback
In May, LexaGene placed its
pre-commercial instrument into the Dartmouth-Hitchcock Medical
Center (DHMC) Laboratory for Clinical Genomics and Advanced
Technology. According to a recent update from the company, the
technology has detected numerous positive samples from those tested
to date.
“From the samples tested to date, we have detected numerous
positive COVID-19 samples as well as negative samples, which are
equally important,” said LexaGene founder and CEO Dr. Jack Regan.
“In contrast to many technologies that only provide a ‘yes’ or ‘no’
answer as to whether the virus was detected, LexaGene’s technology
provides quantitative data on how much virus is detected.”
“By quantifying the amount of virus present, we can help
clinicians determine if a patient is possibly early in the
infection cycle, late in the infection cycle, or if their immune
system successfully contained the growth of the virus. In the
hospital study, we have detected COVID-19 positive samples that are
more than 25,000-fold different in the amount of detected virus.
Quickly identifying individuals with such high viral loads is
especially important for disease containment,” he added.
Potential Vaccine Could Be Available by Early
2021
Although vaccine-makers have been making progress in their
developments, recent guidance from the US Food and Drug
Administration (FDA) suggests that full approval on any given
treatment likely won’t happen until early 2021. The FDA’s guidance, which
was published on July 7, said any vaccine candidate would need to
prove at least 50% more effective than a placebo to earn approval
and that merely showing immune response data would not be enough.
This waiting period for reliable treatment has created an urgent
demand for fast and accurate testing to monitor the spread and help
economies return to normal life.
However, as more experimental vaccines move into Phase 3 trials,
the prospect of a plausible vaccine reaching the market by early
2021 increases. According to White House Coronavirus Task Force
member and Director of the National Institutes of Allergy and
Infectious Diseases, Dr. Anthony Fauci, the safety and
effectiveness of a vaccine for COVID-19 should be known
by “early winter,” with 200 hundred million doses available for
use in the US by early 2021.
Vaccine Hopes Bloom, Testing Demands Abound
Co-Diagnostics
Inc. (NASDAQ: CODX) was issued an EUA in
April for its Logix Smart COVID-19 kit, which is used for the
qualitative detection of nucleic acid from SARS-CoV-2 in lower
respiratory tract fluids and upper respiratory tract fluids from
individuals who are suspected to have COVID-19. The
company closed the first
quarter of 2020 with $1.5 million in revenue due to demand for
its Logix Smart COVID-19 test kits and saw gross margins of 71.5%
on sales on the tests.
Abbott Labs
(NYSE: ABT), which has received EUA for four of its
COVID-19 tests, has continued to ramp up
production to meet the growing demand for fast and accurate
tests. The company’s ID NOW test, which came under scrutiny after
receiving a public
warning from the FDA regarding possible accuracy concerns, has
been praised by the White House, researchers, and clinicians and
drugstore chains because it delivers positive results in as little
as five minutes and negative results in 13 minutes. New data
from an urgent care clinic study revealed promising test results.
Although the results are encouraging, they still fall slightly
below the FDA’s testing
policy, which requires at least 95% of positive samples. Abbott
has shipped almost 4.5 million of its rapid ID NOW tests to all 50
states, Washington DC, Puerto Rico, and the Pacific Islands.
Moderna
(NASDAQ: MRNA), which has been leading the COVID-19
vaccine race with its potential vaccine candidate, was expected to
begin a phase 3 trial with 30,000 participants. However, the
company has reportedly
delayed the start date, possibly by a few weeks, as it makes
changes to the trial plan. According to the report, protocol
changes are common and the company will likely begin the trial this
month.
After publication, Moderna CEO Stéphane Bancel
told CNBC
that the company has been working closely with the National
Institutes of Health and the Trump Administration’s Operation Warp
Speed (OWS) and still intends to start the trial in July.
Meanwhile, late-stage biotech company Novavax Inc.
(NASDAQ: NVAX) is moving ahead with plans to advance its
potential vaccine candidate with new additions to its leadership
team and $200 million in
new funds via a preferred private placement. In May, Novavax
enrolled the
first participants in the Phase 1/2 clinical trial of its
possible vaccine candidate, NVX‑CoV2373, and expects to deliver
preliminary immunogenicity and safety results from the Phase 1
portion of the trial in July.
With several late-stage trials taking place, Fauci is optimistic
a successful vaccine will emerge by the end of the year and hopes
to see more than one winner in the vaccine race. In the meantime,
rapid and accurate tests are necessary for any hope of
reopening.
For further information on LexaGene (TSX.V:
LXG) (OTCQB: LXXGF) please visit LexaGene.
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