The U.S. government is investing a total of $ 248.7 million in seven biotech companies that perform next-generation coronavirus testing, the National Institutes of Health (NIH) announced Friday.
Contracts are awarded through the RADx program, announced in April, after the Trump administration and U.S. health agencies were pledged for shortcomings and inadequate testing.
The U.S. is now testing more than 800,000 people a day – but concerns about accuracy remain, including revelations that the widespread Abbott test used by the White House could return false negatives.
With the number of cases in the South and West increasing and new hotspots emerging, laboratory diagnostics are in high demand, and experts say the US needs to run as many as 10 million tests per day to adequately track the pandemic.
The NIH promised that tests approved or under development at Mesa Biotech, Quidel, Ginkgo Bioworks, Talis Biomedical, Helix OpCo, Fluidigm, and Mammoth Biosciences would help expand and accelerate testing in the U.S. to provide accurate test results cheaply.
Each of the seven tests has gone through a ‘Shark Tank’ style development and assessment process and the investment will go towards scaling up the new tests.
In a press release on Friday, the NIH said that, in addition to Mesa and Quidel’s tests, funding will be used to scale up the other new diagnostics so that they can run up to “ millions of tests per week as early as September 2020, ” said collectively Dr. Francis Collins.
By September, Dr. Collins said the companies furthest in their development processes should each be able to run 50,000 tests per day, and 100,000 tests per day by 2021.
The NIH is investing nearly $ 250 million in seven new coronavirus tests, including Quidel’s Sofia platform, a point-of-care diagnosis
Currently, the vast majority of coronavirus tests used in the US are molecular tests that isolate and amplify pieces of genetic material or enzymes specific to SARS-CoV-2.
These types of tests are the “gold standard” of diagnostics, but they are not perfect and most of them have to be sent to laboratories for analysis, leading to longer waiting times for results or delays.
NIH’s RADx (Rapid Acceleration of Diagnostics) program was launched in April to encourage and accelerate companies to innovate new tests for COVID-19.
It is one of many White House initiatives aimed at using the private sector to tackle the coronavirus pandemic.
More than 600 companies signed up to participate, and 100 were selected to go through a week-long ‘shark tank’ process, 31 went on to a second iteration of a month, and seven were now chosen to scale up.
Three of the tests are point-of-care diagnostics, meaning they can provide results in the same clinic where a patient has been mopped, rather than being sent to a lab for analysis.
The other four are laboratory diagnostics, but use different technologies – called platforms in the diagnostic world – to test for coronavirus.
THE NEW NIH FUNDED TESTS THAT WILL DELIVER RESULTS ON THE SITE
Like most diagnostics already in use, Mesas test for traces of viral DNA in a sample taken from a patient’s nose or throat.
But Mesa’s advantage is its directness and portability.
The entire test is in a portable device with disposable cartridges. It provides results in 30 minutes.
Mesa’s test received FDA approval for emergency use in March, but can scale the tests with the NIH’s investment.
Mesa’s Accula test uses a disposable cartridge and promises on-site results within 30 minutes
The San Diego-based company has also already received FDA approval for its point-of-care test.
Rather than looking for pieces of viral RNA, Quidel’s is an antigen test that searches SARS-CoV-2 through elements of the virus that are on its surface. These are chemically easier to find.
That makes the test relatively faster, but antigen tests have a higher chance of false negatives.
The NIH noted that tests that are slightly less accurate may be more useful in situations such as company reopenings where the problem is less to identify a patient who needs immediate treatment, but more to detect a potential outbreak.
Quidel already has thousands of Sofia analyzers across the United States. Specifically, the Department of Health and Human Services (HHS) has specified that the Quidel test is a good test for nursing homes, where inexpensive, regular testing and rapid outbreak detection are life and death.
The test produces results in just 15 minutes.
Like Mesa’s, the Talis test is a pattern-based test that identifies viral RNA in situ, but with a different technology.
The company says the test produces results within 30 minutes.
U.S. labs are overwhelmed by both coronavirus cases and the demand for testing in places like Florida, where hundreds of cars lined up for drive-thru testing earlier this month
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The Boston-based company makes a lab test, but one that uses automation to speed up the process.
The Ginkgo machine can run thousands of samples at once, thanks to the way the genes of the virus sequence.
It can reverse results in one to two days. It expects to be able to run 50,000 tests per day in September, rising to 100,000 per day by the end of the year.
Like GinkGo, Helix can process thousands of samples simultaneously on its machines.
The test will be specifically sent to public health departments, large companies and healthcare systems in dire need of high-capacity testing.
Fluidigm’s test uses ‘microfluid’ technology that makes the analysis process simpler and faster than that of a standard PCR (polymerase chain reaction) test.
It is not yet clear exactly how many tests a day, Fluidigm’s technology will be able to run, but the NIH estimates it could do tens to hundreds of thousands a day by fall.
While it also makes a lab test, Mammoth’s is unique in the group.
The relatively young company was the first and remains the only test approved by the FDA for using CRISPR – the biochemical tool that allows scientists to manipulate genes – to detect coronavirus.
The CRISPR tool is designed to “find and replace” defective genes, but Mammoth has redesigned it to find coronavirus genes in patient samples.
CRISPR does this with remarkable speed and accuracy, surpassing the CDC’s test.
Mammoth promises that once production is ramped up, the technology will lead to a ‘multiple’ increase in the number of tests that can be done in laboratories.