Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing
As former FDA commissioner Scott Gottlieb, MD, explained on Face the Nation, “this kind of technology is a real game changer … it’s a very rapid test that could be used in a doctor’s office. Doctors now have about forty thousand of these Sofia machines already installed in their offices … you do a simple nasal swab and the test itself scans for the antigens that the virus produces.
“The test is about 85% sensitive. So, let’s say a hundred people come into a doctor’s office who have COVID-19, eighty-five of them are going to be able to be tested positive with this test very quickly. It’s a cheap test. It’ll probably be about five dollars a test and you can get a result within five minutes … you’re getting a very fast result and you can start to take action immediately.
“The company itself said that they’re going to be able to produce about two hundred thousand of these tests starting right away. But in several weeks, they’ll be able to produce up to 1.5 million a week. So, this dramatically expands our testing capacity as long as doctors are able to run these tests in their offices.”
In an interview on CBS’ Face the Nation, former FDA Commissioner Scott Gottlieb, MD (above), said, “These antigen-based tests aren’t as reliable, meaning they’re not as sensitive. So, they’re going to miss some patients who have COVID. But in the hands of a doctor who already has a high index of suspicion that the patient may have the disease … they allow you to dramatically expand testing. And they’re very cheap. They’re very easy to perform. And again, most doctors have these machines already in their offices.” (Photo copyright: US Food and Drug Administration.)
Other LDTs That Have Received EUAs
Here’s a look at other laboratory-developed tests from major manufacturers that have received emergency-use authorizations from the FDA:
This test is designed for use with Abbott’s m2000 RealTime system, which is installed in about 200 US medical laboratories, the company says. It can run up to 470 patient samples in 24 hours. As of a May 11 statement, the company said it had shipped more than two million tests in the US.
This test is designed for use with Abbott’s Alinity m system, which the company describes as its “most advanced laboratory molecular instrument,” with the ability to run up to 1,080 tests in 24 hours, according to a press release.
This is a rapid test designed for use with the ID Now system, a compact portable instrument for point-of-care settings such as urgent care clinics. As of May 11, Abbott said it had shipped more than 1.7 million tests in the US, and that it planned to increase manufacturing capacity to two million tests per month.
However, the test has encountered some stumbling blocks. On May 14, the FDA issued an alert stating that the ID Now COVID-19 test could produce inaccurate negative results. This came after researchers at NYU Langone Health, Northwell Health, and Cleveland Clinic reported problems with the test, according to MedTech Dive. Abbott issued a statement suggesting that the problems were due to improper sample collection and handling, however, the FDA said that Abbott had agreed to conduct post-market studies to identify the cause of the false negatives and suggest remedial actions.
This is a qualitative test designed to detect the presence of IgG antibodies following a SARS-CoV-2 infection. The FDA authorized use of the assay on Abbott’s Architect i2000SR system in April, and then followed up with a May 11 EUA for its use on the Alinity i system. In a statement, Abbott said it planned to ship 30 million tests globally starting in May.
In a March statement, the FDA touted this as the first point-of-care COVID-19 test to receive an EUA. The company estimates the detection time as approximately 45 minutes. It is designed for use with Cepheid’s GeneXpert Dx diagnostic software and GeneXpert Infinity systems, which have nearly 5,000 US installations, according to a Cepheid statement.
This test runs on Hologic’s Panther system, which, according to a Hologic press release, can provide results in about three hours and run more than 1,000 tests per day. The company claims that more than 1,000 Panther systems are installed in US labs, and that it expects to produce an average of one million tests per week.
Ortho’s antibody test is designed for use with its VITROS XT 7600, 3600, 5600, and ECi/ECiQ immunodiagnostic systems, which, the company says are installed in more than 1,000 US labs. The Total Reagent Pack is a qualitative test that detects the presence of all antibodies against SARS-CoV-2.
On April 24, Ortho announced it had received another FDA EUA, this one for its Anti-SARS-CoV-2 IgG test, which detects the presence of IgG antibodies. In a statement, the company said it expects to produce “several million” IgG tests per month.
This test is designed for use with Roche’s cobas 6800 and 8800 systems. The 6800 can process up to 384 results in an eight-hour shift, Roche says, compared with 1,056 results for the 8800 model. The company says results are available in about 3.5 hours. In a statement, Roche said it planned to ship 400,000 tests per week.
Roche describes this as a qualitative antibody test that can be used on cobas e series immunoassay analyzers. Testing time is 18 minutes. As of May 19, the test was live at more than 20 US labs, “with plans in the next several weeks to increase to more than 200 commercial and hospital lab sites with the ability to perform millions of tests per week,” the company stated in a press release.
It’s likely the FDA will continue to issue emergency-use authorizations as the agency receives more applications from IVD manufacturers.
Scientist described the speed at which SARS-CoV-2’s full sequence of genetic material was made public as ‘unprecedented’ and medical labs are rushing to validate tests for this new disease
In the United States, headlines scream about the lack of
testing for the novel Coronavirus
disease 2019 (COVID-19). News reporters ask daily why it is taking so long
for the US healthcare system to begin testing large numbers of patients for
SARS-CoV-2, the virus that causes COVID-19. Yet, pathologists
and clinical
laboratory scientists know that new technologies for gene sequencing
and diagnostic testing are helping public health laboratories bring up tests
for a previously unknown new disease faster than at any time in the past.
At the center of the effort to develop accurate new assays
to detect SARS-CoV-2 and help diagnose cases of the COVID-19 disease are medical laboratory
scientists working in public health
laboratories, in academic medical centers, and in research labs across the
United States. Their collective efforts are producing results on a faster
timeline than in any previous discovery of a new infectious disease.
For example, during the severe
acute respiratory syndrome (SARS) outbreak in 2003, five months passed
between the first recognized case of the disease in China and when a team of
Canadian scientists cracked the genetic code of the virus, which was needed to
definitively diagnose SARS patients, ABC
News reported.
In contrast, Chinese scientists sequenced this year’s
coronavirus (originally named 2019-nCoV) and made it available on Jan. 10,
2020, just weeks after public health officials in Wuhan, China, reported the
first case of pneumonia from the unknown virus to the World Health Organization
(WHO), STAT
reported.
Increases in sequencing speed enabled biotechnology
companies to quickly create synthetic copies of the virus needed for research. Roughly
two weeks later, scientists completed sequencing nearly two dozen more samples
from different patients diagnosed with COVID-19.
Molecular biologist Kristian Andersen, PhD (above right, with graduate students who helped sequence the Zika virus), an Associate Professor in the Department of Immunology and Microbiology at Scripps Research in California and Director of Infectious Disease Genomics at Scripps’ Translational Research Institute, worked on the team that sequenced the Ebola genome during the 2014 outbreak. He told STAT that the pace of sequencing of the SARS-CoV-2 coronavirus is “unprecedented.” (Photo copyright: Scripps Research.)
Lower Sequencing Costs Speed COVID-19 Diagnostics Research
Additionally, a significant decline in the cost of genetic synthesis is playing an equally important role in helping scientists slow the spread of COVID-19.In its coverage of the SARS-CoV-2 outbreak, The Verge noted that two decades ago “it cost $10 to create a synthetic copy of one single nucleotide, the building block of genetic material. Now, it’s under 10 cents.” Since the coronavirus gene is about 30,000 nucleotides long, that price reduction is significant.
Faster sequencing and cheaper access to synthetic copies is
contributing to the development of diagnostic tests for COVID-19, an important
step in slowing the disease.
“This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified medical laboratories is a critical step forward in protecting the public health,” FDA Commissioner Stephen M. Hahn, MD, said in an FDA statement.
However, the Washington Post soon reported that the government-created coronavirus test kits contained a “faulty component,” which as of February 25 had limited testing in the US to only 426 people, not including passengers who returned to the US on evacuation flights. The Post noted that the nation’s public health laboratories took “the unusual step of appealing to the FDA for permission to develop and use their own [laboratory-developed] tests” for the coronavirus.
“This is an extraordinary request, but this is an extraordinary time,” Scott Becker,
Parallel efforts to develop and validate tests for COVID-19
are happening at the clinical laboratories of academic medical centers and in a
number of commercial laboratory companies. As these labs show their tests meet
FDA criteria, they become available for use by physicians and other healthcare
providers.
Dark Daily’s sister publication, The Dark Report just published an intelligence briefing about the urgent effort at the clinical laboratory of Northwell Health to develop both a manual COVID-19 assay and a test that can be run on the automated analyzers already in use in the labs at Northwell Health’s 23 hospitals. (See TDR, “Northwell Lab Team Validates COVID-19 Test on Fast Timeline,” March 9, 2020.)
Following the FDA’s March 13 EUA for the Thermo Fisher test,
Hahn said, “We have been engaging with test developers and encouraging them to
come to the FDA and work with us. Since the beginning of this outbreak, more
than 80 test developers have sought our assistance with development and
validation of tests they plan to bring through the Emergency Use Authorization
process. Additionally,” he continued, “more than 30 laboratories have notified
us they are testing or intend to begin testing soon under our new policy for
laboratory-developed tests for this emergency. The number of products in the
pipeline reflects the significant role diagnostics play in this outbreak and
the large number of organizations we are working with to bring tests to
market.”
Pharma Company Uses Sequencing Data to Develop Vaccine in
Record Time
Even as clinical laboratories work to develop and validate diagnostic tests for COVID-19, drug manufacturers are moving rapidly to develop a COVID-19 vaccine. In February, Massachusetts-based biotechnology company Moderna Therapeutics (NASDAQ:MRNA) announced it had shipped the first vials of its potential coronavirus vaccine (mRNA-1273) to the National Institute of Allergy and Infectious Disease (NIAID) for use in a Phase One clinical trial.
“The collaboration across Moderna, with NIAID, and with CEPI [Coalition for Epidemic Preparedness Innovations] has allowed us to deliver a clinical batch in 42 days from sequence identification,” Juan Andres, Chief Technical Operations and Quality Officer at Moderna, stated in a news release.
The Wall Street Journal (WSJ) reported that NIAID expects to start a clinical trial of about 20 to 25 healthy volunteers by the end of April, with results available as early as July or August.
“Going into a Phase One trial within three months of getting the sequence is unquestionably the world indoor record,” NIAID Director Anthony Fauci, MD, told the WSJ. “Nothing has ever gone that fast.”
There are no guarantees that Moderna’s coronavirus vaccine
will work. Furthermore, it will require further studies and regulatory
clearances that could delay widespread distribution until next year.
Nonetheless, Fauci told the WSJ, “The only way you
can completely suppress an emerging infectious disease is with a vaccine. If
you want to really get it quickly, you’re using technologies that are not as
time-honored as the standard, what I call antiquated, way of doing it.”
In many ways, the news media has overlooked all the important
differences in how fast useful diagnostic and therapeutic solutions for
COVID-19 are moving from research settings into clinical use, when compared to
early episodes of the emergence of a new infectious disease, such as SARS in
2003.
The story the American public has yet to learn is how new
genetic sequencing technologies, improved diagnostic methods, and enhanced
informatics capabilities are being used by researchers, pathologists, and
clinical laboratory professionals to understand this new disease and give
healthcare professionals the tools they need to diagnose, treat, and monitor
patients with COVID-19.
Any change of ownership in the fifth largest in vitro diagnostics company would represent a major development in the medical laboratory testing marketplace
Medical laboratory managers may see more consolidation in the in vitro diagnostics market if executives at Johnson & Johnson (NYSE: JNJ) decide to sell its Ortho Clinical Diagnostics (OCD) unit. This decision was announced earlier this week during J&J’s conference call to discuss its fourth quarter 2012 financial report.
Ortho Clinical Diagnostics is considered the fifth largest IVD company. Thus, any sale or spin-off of this $2 billion enterprise will be a significant development for the clinical laboratory and pathology testing industry. (more…)
Earlier this week, Digene Corporation (Nasdaq: DIGE) announced that it would be acquired by Dutch firm Qiagen (Nasdaq: QEN) for a purchase price of approximately $1.6 billion. Digene has been involved in patent infringement lawsuits during the past year in efforts to protect its HPV patents.
It was announced on Monday, June 4, that Digene will be purchased by Qiagen, a Dutch maker of tools for gene research. This gives Quiagen access to Digene’s patented HPV test, and tests for sexually transmitted diseases. Digene’s HPV test is the only one that has been approved in the U.S. and Europe. The purchase gives Qiagen “instantaneous market and technology leadership” in molecular diagnostics and will be “a catalyst for growth,” Peer M. Schatz, CEO of Qiagen, said.
It was announced back in January that Digene was suing Third Wave Technologies (Nasdaq: TWTI) over alleged patent infringement. The suit alleged that Third Wave infringed on a biotechnology patent involving human detection of the human papilloma virus (HPV).
Third Wave countersued Digene in early March by filing an anti-trust suit that alleged that Digene “abused its monopoly power to thwart competition” in the HPV diagnostic market. The current legal action is interesting because Digene and Third Wave had earlier entered into an agreement to dismiss, without prejudice, a declaratory judgment action filed by Third Wave against Digene for the same HPV detection technology. It was January 2006 when both parties agreed to throw out that lawsuit.
Digene has also been pursuing legal action against Ventana Medical Systems (Nasdaq: VMSI) in another patent infringement lawsuit. Last month the U.S. District Court for the State of Deleware denied Digene’s motion for a preliminary injunction against Ventana. “Although we are disappointed with the court’s ruling, the denial of our preliminary injunction request was not unexpected given the pending expiration of the patents at issue in May and June,” said Daryl Faulner, President and CEO of Digene. In the ruling, the court noted that there remains a substantial question as to whether Ventana has a license to the relevant HPV patents.
Digene’s acquisition by a larger in vitro diagnostics (IVD) manufacturer is another example of the ongoing consolidation in the IVD industry. Along with the strong price Qaigen is paying, it demonstrates the high interest investors have in molecular diagnostics. Interestingly, during May, another major IVD company in cervical cancer screening was acquired. Cytyc Corporation (Nasdaq: CYTC) is being sold to Hologic (Nasdaq: HOLX) in a deal valued at $6.2 billion and expected to close during the third quarter.
Should acquisitions continue in the IVD industry at the current pace, it will certainly change the competitive landscape. Further, much of the molecular technology currently finding its way into new clinical assays has been developed by start-up companies. For that reason alone, the established IVD giants will need to scramble to develop or acquire comparable molecular technology that will help them maintain market share.
Related Articles:
Digene sues Third Wave over patent
(last article at the bottom of the page)
In a deal made public only Sunday, Cytyc Corporation has agreed to be acquired by Hologic. Hologic will pay $6.2 billion for Cytyc, which had revenues in 2006 of $608 million. The price paid represents a 33% premium for Cytyc shares, based on prices at the close of the market on Friday.
When the deal closes, probably sometime between July 1 and September 20, another in vitro diagnostics (IVD) manufacturer will have lost its independence. In this acquisition, Hologic’s prime interest is not Cytyc’s cervical cancer screening products. Instead, Hologic is particularly interested in Cytyc’s product lines for breast cancer, including its Mammosite radiation treatment. That’s because Hologic, with annual revenues of $462.7 million in 2006, has a line of breast cancer diagnostic devices, including an imaging system.
Three things are driving this deal. First, both companies serve the same primary market: ob-gyns. Not only will this help with recognition for the combined company, but it opens up opportunities to cross sell one company’s products to other company’s customers. In particular, since 90% of the nation’s ob-gyns currently use Cytyc’s ThinPrep Pap tests, Hologic believes it can benefit from selling to these physicians.
Second, there are certain economies of scale and other savings that will be realized by combining the two companies. However, layoffs are not planned, and both companies’ CEOs have emphasized that Hologic, post-acquisition, will have 1,200 sales people to promote its products.
Third, the two companies are located within 15 miles of each other, which will help make integration easier. Hologic is based in Bedford, Massachusetts and Cytyc’s corporate office is in Marlborough, Massachusetts. It also turns out that Hologic CEO Jack Cumming and Cytyc CEO Patrick Sullivan live in the same town. Maybe that’s why Cumming’s told analysts that the two companies were “kindred spirits” because of the way their core products complement each other and the fact that so many employees of both firms live in the same region.
Once the acquisition is completed, the company will be called Hologic and Cytyc will operate as a wholly-owned division of Hologic. Cytyc CEO Sullivan is slated to become Hologic’s Chairman and Cumming will be Chief Executive Officer.
Most laboratory managers and pathologists view Cytyc as a company that has a major presence in the market for cervical cancer screening products. That is true, but in recent years Cytyc Corporation has acquired a number of technologies and companies that provide services in other areas of women’s health. Several of these new business lines are growing rapidly. For example, during first quarter 2007, Cytyc’s domestic revenues from its diagnostic products, including cervical cancer screening products, totaled $89.2 million. That was a growth rate of 11% over first quarter, 2006. By contrast, revenues from domestic sales of its surgical products totaled $59.3 million, representing a growth rate of 33% over the revenues of $44.7 million in first quarter 2006.
For first quarter 2007, Cytyc failed to post a net profit. On sales of $169.9 million for the quarter, it showed a loss of $51.2 million, compared to a profit of $29.4 million during the same period a year prior.
Related Articles:
Hologic and Cytyc to Merge Creating a $10 Billion Global Leader in Women’s Healthcare
