The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.

According to FIND Dx, there are almost 700 tests in development or granted some sort of regulatory nod (not necessarily full approval, however). That includes 341 molecular tests – from independent labs, major companies, to smaller firms. Indeed, the U.S. FDA has granted emergency use authorization (EUA) to quite a few offerings, while other tests have won the CE-IVD or nods from other regulators, including China, Brazil and South Korea.

There is a great need for a lot of molecular tests. As Cowen analysts reported last month, it is expected that big diagnostic players could support production of about 30 million tests a month by the end of June. “Further capacity expansion could be required heading into September (the beginning of northern hemisphere respiratory season) where COVID-19 testing will be common (it isn’t likely to go away, but you never know), and to account for demand by health providers, employers and others.”

They went on to note that this should be a sufficient level of testing for clinical needs, but not necessarily for broad employer screening. Perhaps even more amazingly, the Cowen analysts said they believe it’s possible the companies could sell every test they make this year, highlighting the major companies in its coverage, including Abbott Laboratories and Hologic Inc.

How many tests could that entail? The analysts predicted anywhere between 45 million and 85 million tests by the end of August in the U.S. and Europe alone. And that could be too low of a figure, given that it might miss repeat testing for those who test positive or for those undergoing elective procedures.

The news rapidly changes. For example, May 5 saw an EUA for Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) for a molecular test. And Hercules, Calif.-based Bio-Rad Laboratories Inc. reported May 4 that its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit had won EUA, something that was confirmed by the FDA’s website. The test runs on Bio-Rad’s QX200 and QXDx ddPCR systems.

According to the company, the test’s high sensitivity makes it a good candidate to screen upper respiratory samples in patients with a low viral load, including those in the early stages of infection. The test can also play an important role in surveillance by detecting minimal residual disease in people recovering from COVID-19, informing them if they are negative for the virus.

Word of the EUA came mere days after the company revealed it had launched its SARS-CoV-2 Total Ab test, which is a blood-based assay to identify all the antibodies that are developed by the human body in response to SARS-CoV-2.

Challenges

Despite the enthusiasm of company executives to get their products to market, obstacles remain. For example, in the U.S., there have been challenges in terms of obtaining testing supplies, as William Blair analyst Brian Weinstein has highlighted. At one point, he proposed a private-public partnership to match supply with demand.

“None whatsoever,” he told BioWorld when asked whether that idea had gained traction. “We still think [there is] some way to get real-time testing capacity information to logistical partners who can move collected samples around makes sense.” For example, he noted that if he were to order a size 10.5 tennis shoe via Amazon, he could get it the following morning. “[S]o why can’t the government work with that company [or others] to get collected test samples to where there is capacity?” he asked.

Still, a broader effort such as the one proposed by Weinstein may prove less crucial as additional capacity comes online. That means local capacity will open. Still, with rapid antigen testing, the need to transmit data to government entities quickly will prove crucial. “Some cooperation between the government and testing companies to facilitate that will need to take place,” he explained. “If run successfully, that can go a long way in minimizing outbreaks as we start to open up again.”

Abbott, Hologic

One of the biggest players in the COVID-19 testing front is Abbott Laboratories. Indeed, the Abbott Park, Ill.-based company was quick to gain an EUA for its molecular test for COVID-19 on March 18. Abbott said at the time that it would immediately ship 150,000 Abbott Realtime SARS-CoV-2 EUA tests to existing U.S. customers. The tests are used on the company's m2000 Realtime System.

The same month, the company won an EUA for what was dubbed the fastest available molecular point-of-care (POC) test for the detection of COVID-19, delivering positive results in as little as five minutes and negative results in 13. The test runs on the company's ID Now platform, providing results in a range of health care settings, such as physicians' offices, urgent care clinics and hospital emergency departments.

Still, as Weinstein noted, capacity issues have limited the company’s POC molecular test. And while some institutions complained about poor performance, user error could have played a role.

BioWorld asked Weinstein whether Abbott could take a hit as a result. He answered that diagnostics represents a little less than a quarter of Abbott’s total revenue. In addition, ID Now, the platform that was the subject of reports of assay issues, is only a tiny percentage of that. Weinstein went on to add that the platform should realize revenues of $2 million a day, or 50,000 units at $40 each.

Also of note is the huge demand for anything related to COVID-19 diagnostics. As a result, “we anticipate that the company will continue to sell most, if not all, of its assays across the spectrum of the tests it offers, including ID Now.”

Going forward, Weinstein said he believes that COVID-19 diagnostics can benefit Abbott to the tune of $860 million of revenue. That includes ID Now revenue of $285 million. It also could include $575 million if it proves able to sell the committed numbers on its m2000 molecular system “[W]e are skeptical it can run this much in terms of the instrument capacity in the U.S.,” Weinstein added as an aside. “When factoring in serology testing, which should add $800 million, we see peak COVID-19 testing revenue for the products announced thus far at Abbott to be about $1.6 billion,” he continued

Further, Weinstein’s organization does not expect any problems in terms of sales with these products, and even if there were, that should not affect Abbott’s overall financial stability. “Broadly speaking, Abbott is extremely well capitalized with cash of $3.7 billion and a leverage ratio of 1.7 times.”

Abbott saw its first-quarter revenue beating expectations, coming in at $7.73 billion vs. an expected $7.44 billion.

Marlborough, Mass.-based Hologic, meanwhile, unveiled another tool to help combat COVID-19, with the Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its Panther system. The company expects to be able to provide its lab customers with about 3 million Aptima tests next week. In addition, it anticipates producing about 1 million tests a week starting in late June.

Weinstein has viewed the potential of this solution, noting that it has the potential to double weekly testing volumes, as well as benefit the company. “While we cannot predict how long the need for millions of weekly tests at this level will continue, we can confidently state that Hologic is uniquely positioned among the larger, diversified medical technology companies to be able to have a massive offset to business headwinds,” he wrote in a note highlighting the company’s quarterly results.

Quidel, BD

Weinstein also highlighted Quidel Corp. and Becton, Dickinson & Co. (BD) as possible players in this space. San Diego-based Quidel offers tests that can be run on rapid immunoassay platforms. “These tests are often viewed as less sensitive than their molecular counterparts, but given that they can be deployed at the POC (whether that be a physician’s office, retail clinic, employer, etc.), there is tremendous value to the system,” Weinstein wrote April 24. One solution could be the Quidel Sofia system, as it has a presence in retail clinics, in addition to physician offices. With more than 40,000 units placed, this offering’s footprint exceeds that of the molecular POC systems, even the aforementioned ID Now, “which is running tests on only 3,000 of its 18,000 systems in the field and has recently been reported to have poor performance at some sites, and Cepheid’s 5,000 systems.”

Franklin, N.J.-based BD reported April 13 that the FDA had granted EUA for an additional molecular diagnostic test for COVID-19 that can return results in two to three hours. The new test also has been CE marked. BD also has a good number in terms of installed base at roughly 25,000 units.

Cowen’s Josh Jennings wrote April 27 that BD has several COVID-19 molecular diagnostic testing options that will run on the BD Max molecular diagnostic system. “BD Max is used in hundreds of laboratories in nearly every state in the U.S. and in thousands of laboratories worldwide and can process 24 samples simultaneously with results in two to three hours.

Quidel’s earnings call took place May 6, while BD’s is slated to take place May 7.

Mesa Biotech

While public companies have received a lot of attention, private firms are responding, too. For example, Mesa Biotech Inc., of San Diego, reported March 24 that it had secured EUA for its Accula SARS-CoV-2 Test, which gives COVID-19 diagnostic results in 30 minutes.

“Our customers love the easy-to-use design of our platform technology,” Ingo Chakravarty, president and CEO of Mesa Biotech, told BioWorld when asked about feedback received thus far. “The sample preparation steps are just a very few, especially compared [with] other testing platforms out there.”

Chakravarty pointed to the system’s simplicity: A nasal swab is taken then inserted in a buffer vial and stirred five times. A pipette sample is put in the test cassette, and the lid is closed. “That’s it,” he added.

“In addition, and probably even more important, our platform technology utilizes true PCR technology, called thermal, end point PCR. Thermal PCR is considered the gold standard in clinical lab testing. Hence, we trust that our test performance is providing our customers with the best of both worlds, central lab testing quality, in a palm sized, highly mobile format.

When asked about obstacles to getting testing out more broadly, Chakravarty, who joined the company just a few weeks ago, highlighted the supply chain and access to product components, as demand is far exceeding the ability to produce. “That said, we are putting significant resources in place to improve capacity on a weekly basis.” He concluded that the company has worked with a range of stakeholders to deploy testing capabilities at scale across the U.S.

Editor's note: This article is part of a series of stories assessing the state of the rapidly evolving COVID-19 diagnostics.

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