March 30, 2020 - The FDA has authorized a coronavirus test that the manufacturer says can tell if someone is infected with the virus within 5 minutes.
The test is meant to be used in places like a doctor's
office, emergency room, or urgent care center. The test will provide
results through a platform currently used by many of those locations for
tests like flu and strep, instead of sending the throat or nasal swab
to a lab for analysis.
The FDA's emergency use authorization (EUA), issued on
Friday, does not mean that the FDA has approved the test, but that it is
allowing its use because of the coronavirus outbreak.
In a news release,
Abbott Diagnostics Scarborough in Illinois said the test can tell if a
person has the coronavirus in as little as 5 minutes and tell if someone
doesn't have the virus in 13 minutes.
A shortage of tests has hindered efforts to contain the
virus in the U.S, which leads the world with more than 100,000 cases of
COVID-19. Testing has been focused on priority groups, such as
hospitalized patients and health care professionals with symptoms,
according to CDC guidelines.
Abbott said it will make the tests available to health care
providers next week and work with the government to send the tests to
areas where they're most needed.
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A medical worker screening people for COVID-19 in Jammu and Kashmir (representational image) | Photo: ANI
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New Delhi: With the novel coronavirus going from
‘regional crisis’ to ‘pandemic’ status, researchers and pharmaceutical
giants are scrambling to find a cure.
The World Health
Organization (WHO) has launched global clinical trials to test possible
treatments for COVID-19 across 10 countries as a “solidarity trial”.
Some of the treatments to be tested are drugs already being used for other illnesses like HIV, Ebola and malaria.
Top drugs under trial include anti-malarial medicine chloroquine,
anti-viral drug remdesivir, a combination of HIV drugs lopinavir and
ritonavir, as well as a combination of the latter two drugs infused with
Interferon beta.
The popular anti-parasitic medication which treats malaria has been
around since the 1940s. US President Donald Trump Thursday called it a “game changer”, and proposed its use for COVID-19 cases.
However, American drug regulator, Food and Drug Administration (FDA), said “the agency is currently looking at widespread clinical trials of the drug, but it is not yet approved for that use”.
Biotech investor and doctor Mike Pellini was the first to use chloroquine as a possible cure for coronavirus.
Tech entrepreneur Elon Musk also tweeted that chloroquine was “maybe worth considering” as a potential treatment.
Chloroquine works by increasing the levels
of haem or heme — a substance toxic to the malarial parasite — in the
blood. This kills the parasite and stops the infection from spreading.
According to some earlier studies, “chloroquine has strong antiviral effects on SARS-CoV infection of primate cells”. One study showed
that chloroquine interferes with “terminal glycosylation of the
cellular receptor, angiotensin-converting enzyme 2”, which may
negatively influence the virus-receptor binding and abrogate the
infection.
Chloroquine is widely available in India, and is manufactured by
several local companies including Ipca Laboratories, Alembic
Pharmaceutricals and Cadila Pharmaceuticals.
If the drug works as a cure for the novel coronavirus, scaling up production won’t be difficult.
Foreign drug makers like Abbott, Bayer and Leo Pharmaceuticals also sell this drug in India.
Another drug in the spotlight is remdesivir — an anti-viral developed
by drugmaker Gilead, which specialises in manufacturing anti-HIV drugs. According to the WHO, remdesivir may have the best shot at treating COVID-19.
Remdesivir is an investigational broad-spectrum anti-viral drug,
which was developed to fight the Ebola virus. It is currently undergoing
clinical trials on coronavirus patients in China. WHO expects the trial
data to be available within weeks, according to media reports.
At a press briefing
in Beijing, WHO assistant director-general Bruce Aylward said: “There
is only one drug right now that we think may have real efficacy, and
that’s remdesivir.”
It was previously tested on humans with the Ebola virus disease, and has shown promise
in animal models for treating Middle East Respiratory Syndrome (MERS)
and Severe Acute Respiratory Syndrome (SARS), which are caused by other
coronaviruses. Also read:Govt sets up science and tech core team to coordinate efforts against coronavirus
Japanese flu pill favipiravir
According to a report in The Guardian
which, in turn, quoted a Japanese media report, “medical authorities in
China have said a drug used in Japan to treat new strains of influenza
appeared to be effective in coronavirus patients”.
The reports said doctors in Japan are using the drug in clinical
studies on COVID-19 patients with mild to moderate symptoms. However,
the drug has not shown great results on patients with severe symptoms.
The reports quoted Zhang Xinmin, an official in China’s science and
technology ministry, as saying: “Favipiravir, developed by a subsidiary
of Fujifilm with brand name Avigan, had produced encouraging outcomes in
clinical trials in Wuhan and Shenzhen involving 340 patients.
“It has a high degree of safety and is clearly effective in treatment,” Xinmin said.
The use of favipiravir showed definite improvements in lung condition
in 91 per cent of the patients treated with it, compared to 62 per cent
of those treated without the drug. Also read:One coronavirus patient infects 1.7 people in India, much lower than in China, Italy: Study
Plasma therapy
The US FDA is currently evaluating
therapies such as convalescent plasma and hyperimmune globulin. These
are antibody-rich blood products are taken from the blood donated by
people who have recovered from COVID-19. Research is going on to check
if these products “could shorten the length, or lessen the severity, of
the illness”.
Japanese drugmaker Takeda Pharmaceutical is also developing a therapy against the coronavirus using blood plasma. Bloombergreported
that with its background in manufacturing immunoglobulin-based products
approved by top regulating bodies across the globe, including the US
FDA, “the Japanese pharmaceutical company could have an edge because the
treatment involves a process that already has approval from
regulators”.
However, Takeda has not yet tested the therapy on any COVID-19 patients. Also read:No new cases in China to clean Venice waters — the latest on COVID-19
Combination of HIV drugs
Several patients across the globe have reported benefits from
treatment with a combination of HIV drugs — lopinavir and ritonavir.
Lopinavir, which acts against the viral 3CL protease, has modest
anti-viral activity against SARS-CoV-2 (the novel coronavirus),
according to an study published in The New England Journal of Medicine (NEJM).
“Together with ritonavir, which increases drug bioavailability, it is
in clinical trials, along with the immunomodulator interferon beta-1b,
for the treatment of Middle East Respiratory Syndrome (MERS),” the
article stated.
In India, the Union health ministry has also recommended the use of
anti-HIV drug combinations for high-risk groups of patients, but there
is no current evidence from randomised controlled trials to recommend a
specific treatment.
However, according to another study published in the NEJM,
these drugs have failed to cure COVID-19. A clinical trial in Beijing
tested the lopinavir-ritonavir combination on people who were severely
ill, but the outcomes of 94 people who received them were no different
from 100 patients who received standard care, the study stated. However,
it drew an open-ended conclusion.
“In hospitalised adult patients with severe COVID-19, no benefit was
observed with lopinavir-ritonavir treatment beyond standard care. Future
trials in patients with severe illness may help to confirm or exclude
the possibility of a treatment benefit,” the study said.
The kits developed by the Pune-based firm are claimed to be
completely made in India. “The kits will eliminate the requirement of
two tests — screening and confirmatory testing. Rather, it will give the
results within two-and-a-half hours of loading the samples on the
machine,” Mylab Discovery managing director Hasmukh Rawal told ThePrint.
Dr Gautam Wankhede, director of medical affairs at Mylab, said,
“Since the test is based on the sensitive PCR technology, even early
stage infection can be detected with our kits. Per day, over 10,000
tests can be done and capacity can be increased.”
Mylab, in 2019, was recognised as India’s first FDA-approved
molecular diagnostics company for the RT-PCR-based kits for testing HIV,
Hepatitis B and C.
“With our expertise in the field of molecular diagnostics, the cost
of testing will be much lesser with our kits in comparison to the
foreign made kits. Their price of testing per sample is more than twice
our price,” Wankhede said, without disclosing the price.
Mylab is the first company in Asia and second in the world to
manufacture ID-NAT kits, which check blood samples to reduce risk of
transfusion-transmitted infections in recipients. Also Read: Why doctors in Italy are letting some coronavirus patients die to save others
Trivitron can produce 7.5 lakh kits every day
Trivitron Healthcare also calls its diagnostic test kits for COVID-19 the country’s first indigenous kit.
“The kit can be used in all five sample types recommended by ICMR and
WHO. The costs are still being worked out. We have allocated Rs 4 to 5
crore emergency funds to upgrade our R&D infrastructure for
launching hand sanitisers and COVID-19 kits,” Dr G.S.K. Velu, Chairman
& Managing Director, Trivitron Healthcare Group, told ThePrint.
“The standard turnaround time is normally 2-3 days, but Trivitron is
trying to reduce (the time) to 3-5 hours for generating results.”
“The kits by our joint venture company in China, Labsystems
Diagnostics Shandong, are approved and sold there. China and we are
planning to use that expertise and components to make them in India,” he
said.
The company is waiting for approvals from the National Institute of
Virology for validation protocols and positive samples. “In the next two
to three weeks, as long as we complete our validation in
government-approved institutions, 500 to 750,000 test kits can be
produced per day.”
Roche says its kit will give results in 3 hrs
Roche, Swiss diagnostic and pharma giant, has received emergency use
authorisation from the United States’ regulator Food and Drug
Administration (FDA) for its SARS-CoV-2 test.
“Roche Diagnostics India is keen to partner with the Government’s
efforts in their drive to manage the COVID-19 infection situation. We
have the potential to offer 3 types of test kits that can be used to
screen and further diagnose COVID-19 infections on our existing systems
that run other infectious disease panels. These systems are installed
across India’s 15 major cities,” Dr Shravan Subramanyam, Managing
Director, India and Neighbouring Markets, Roche Diagnostics India
Private Limited, told ThePrint in an email.
According to the company’s media release, the test kits — Roche’s
cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2
Test — “provide test results in three and a half hours”.
The company also claims it provides up to 96 results in about three
hours and a total of 384 results for the cobas 6800 System technology
whereas 960 results are produced for the cobas 8800 System in eight
hours.
11 hours ago - U.S. DEPARTMENT of STATE — BUREAU of CONSULAR AFFAIRS ... State.Gov > U.S. Visas News > Update on H and J Visas for Medical ...
Last Updated: March 26, 2020
We encourage medical professionals seeking to work in the
United States on a work or exchange visitor, particularly those working
to treat or mitigate the effects of COVID-19, to reach out to the
nearest embassy or consulate to request a visa appointment.
Patients given the medicine in Shenzhen turned negative in a median of four days
Photograph: John Minchillo/AP
Medical authorities in China have said a drug used in Japan to treat new strains of influenza appeared to be effective in coronavirus patients, Japanese media said on Wednesday.
Zhang Xinmin, an official at China’s science and technology ministry,
said favipiravir, developed by a subsidiary of Fujifilm, had produced
encouraging outcomes in clinical trials in Wuhan and Shenzhen involving
340 patients.
“It has a high degree of safety and is clearly effective in treatment,” Zhang told reporters on Tuesday.
Patients who were given the medicine in Shenzhen turned negative for
the virus after a median of four days after becoming positive, compared
with a median of 11 days for those who were not treated with the drug,
public broadcaster NHK said.
In addition, X-rays confirmed improvements in lung condition in about
91% of the patients who were treated with favipiravir, compared to 62%
or those without the drug.
Coronavirus: the week explained - our expert correspondents put a week’s worth developments in context in one email newsletter
Fujifilm Toyama Chemical, which developed the drug – also known as Avigan – in 2014, has declined to comment on the claims.
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in the firm surged on Wednesday following Zhang’s comments, closing the
morning up 14.7% at 5,207 yen, having briefly hit their daily limit
high of 5,238 yen. Doctors in Japan
are using the same drug in clinical studies on coronavirus patients
with mild to moderate symptoms, hoping it will prevent the virus from
multiplying in patients. But a Japanese health ministry source suggested the drug was not as
effective in people with more severe symptoms. “We’ve given Avigan to 70
to 80 people, but it doesn’t seem to work that well when the virus has
already multiplied,” the source told the Mainichi Shimbun.
The same limitations had been identified in studies involving
coronavirus patients using a combination of the HIV antiretrovirals
lopinavir and ritonavir, the source added.
In 2016, the Japanese government supplied favipiravir as an emergency aid to counter the Ebola virus outbreak in Guinea.
Favipiravir would need government approval for full-scale use on
Covid-19 patients, since it was originally intended to treat flu.
A health official told the Mainichi the drug could be approved as
early as May. “But if the results of clinical research are delayed,
approval could also be delayed.”
March 30, 2020 - The FDA has authorized a coronavirus test that the manufacturer says can tell if someone is infected with the virus within 5 minutes.
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