The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
He highlighted the emergency use authorization (EUA) for Roche Holding AG’s SARS-CoV-2 test that runs on the Cobas 6800/8800 systems. Weinstein noted that this represented an example of how all actors can come together to bring products to the market. Also, it is likely that a host of new products will be approved via EUA in the next few days.
Still, there are a number of challenges, including the debilitating effects of reimbursement cuts on lab infrastructure, Weinstein said, and that has led to a lack of investment in additional capacity. The hiring of capable personnel also has been affected by these cuts.
“In our discussions with lab directors this week, they noted that getting an assay up and running was a big challenge because they did not have the skilled labor needed to make a laboratory developed assay (all that is available) and then run it on instruments that are not fully automated,” Weinstein wrote.
As a result, a number of labs must wait for the development and approval of manufactured kits to run on instruments automated in their lab. “In fact, some of the largest regional labs do not have any LDT capabilities and are at the hands of manufacturers to get things through the FDA EUA process,” according to Weinstein. South Korea and other countries, on the other hand, have centralized personnel.
“The Roche approval will help larger labs get up and running, but smaller labs will need additional options from these manufacturers, which we expect will occur in the coming days and weeks,” Weinstein said.
Other big players
Despite such challenges, companies are working hard to tackle the COVID-19 crisis and bring products to the market. For example, Thermo Fisher Scientific, of Waltham, Mass., gained the FDA’s fourth COVID-19 diagnostic EUA for its Taqpath COVID-19 Combo Kit. It is designed to provide patient results within four hours of a sample being received by a lab.
Thermo Fisher said it has 1.5 million tests available to ship under the EUA label and expects to quickly ramp up to reach 2 million tests per week. In April, the company expects to scale production up to 5 million tests per week.
During the Cowen HealthCare Conference March 2, analyst Doug Schenkel asked Thermo Fisher CEO Marc Casper about the company’s work with the CDC to develop a testing kit. “Our qPCR [polymerase chain reaction] instrumentation is used in the CDC specs and a number of other government specs in terms of you use our instruments to run the assays to determine it. So, just in the protocols of the CDC are using, that's there. As is our master mixes and amplification capabilities so that you can actually determine the test.”
At the same time, Venlo, Netherlands-based Qiagen NV, which Thermo Fisher recently said it would buy for $11.5 billion, also is working on COVID-19. On March 13, Qiagen revealed that it will develop a new Qiastat-Dx test kit to differentiate the novel SARS-CoV-2 coronavirus from 21 other respiratory infections. The solution is aiming for the Biomedical Advanced Research and Development Authority (BARDA) streamlined selection process. To that end, BARDA will contribute $598,000 to accelerate the company’s evaluation of the testing cartridge that detects the genetic material of SARS-CoV-2.
Meanwhile, BARDA is giving about $700,000 to accelerate the development of Hologic Inc.’s COVID-19 molecular diagnostic. It is intended for use along with Hologic’s Panther Fusion system, which can process up to 1,000 tests in 24 hours and could make COVID-19 results available to clinicians in less than three hours.
Chembio Diagnostics Inc., of Hauppauge, N.Y., said it formed a global strategic partnership with Lumiradx Ltd., of London, to develop point-of-care diagnostic tests on the platforms of both companies to detect the COVID-19 virus and IgM and IgG antibodies.
Kyle Bauser from Dougherty & Co. asked Chembio management to provide a little more color on its COVID-19 plans in terms of this deal during the company’s March 12 earnings call. Gail Page, interim president and CEO, said the two were trying to get to the FDA as expeditiously as possible.
“Obviously, we have been doing some feasibility work and monitoring and measuring things as they have developed. So, it's our goal to … bring something to the market as soon as possible, but we want to bring something that's commercially viable, something that can make a difference and is not just noise in the market,” Page added.
For its part, Avellino Lab USA Inc. has developed a diagnostic test, which physicians can order now, while the company continues testing. Physicians can collect cell samples in their offices by swabbing a patient’s nose and throat that can be analyzed in Avellino’s CLIA certified high-complexity molecular testing laboratory facility in Menlo Park, Calif.
Also contributing to the efforts is Elmwood Park, N.J.-based Bioreference Laboratories Inc., an Opko Health company, which is accepting specimens for testing from health care providers, clinics and health systems throughout the U.S. The company also has a partnership with the New York State Department of Health to provide testing for the first public drive-through testing facility on the East Coast in New Rochelle.
Biomérieux reported the forthcoming launch of three tests to address the COVID-19 epidemic. Specifically, it has finalized the development of the SARS-COV-2 R-GENE test, which is clinically validated on one type of respiratory specimen and will be available at the end of March. The company said it expects to submit to the FDA for an EUA as well.
Meanwhile, Huntsville, Ala.-based Diatherix Eurofins, part of Eurofins Scientific, and will begin accepting specimens for testing March 17. According to the company, its panel will give clinicians the ability to confirm the presence of SARS-CoV-2 along with additional diagnostic information of synergistic bacteria.
Academic-medical laboratories also are taking up the challenge. For its part, Arup Laboratories started COVID-19 testing March 12. The molecular diagnostic assay is designed to detect RNA of SARS-CoV-2 in respiratory specimens of patients meeting the CDC’s clinical criteria for COVID-19 testing. It is performed using a qualitative polymerase chain reaction method similar to that used for other qualitative molecular assays. The test is specific to SARS-CoV-2 and does not detect additional coronaviruses.
Also, the Center for Innovation and Discovery within Hackensack Meridian Health, a partner in the Hackensack Meridian School of Medicine at Seton Hall University, has created a new test that it says cuts the wait-time for results down to as little as just two hours.
While testing has been the focus, telehealth also could play an important role as the crisis continues. Companies such as Techsee, of Tel Aviv, Israel, are playing a role. For its part, Techsee is providing European organizations with free access to its Visual Assistance products for contact centers, enabling them to deliver uninterrupted service during the current COVID-19 crisis.
A list of diagnostic offerings for COVID-19, which will be updated, is available on the BioWorld website.