Companies around the world are racing to develop and distribute tests for COVID-19 to laboratories and to market other products and services they say can help patients and healthcare providers cope with the pandemic.
On March 13, the FDA gave Thermo Fisher Scientific (NYSE:TMO) emergency use authorization (EUA) for a diagnostic test that certain U.S. laboratories can use to detect SARS-CoV-2, the type of coronavirus that causes COVID-19. Labs can produce the test’s results in four hours, according to ThermoFisher.
The company has 1.5 million tests available to ship under the EUA label to be distributed to approximately 200 labs in the U.S. Thermo Fisher said it expects to quickly ramp up to reach 2 million tests per week and could produce up to 5 million tests per week during April based on the availability of raw materials and an installed instrument base. More information can be found here.
Also on March 13, Roche (SWX: RO, ROG) announced its Cobas SARS-CoV-2 test as the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic. The tests run on 827 high-volume Cobas 6800/8800 systems that Roche has installed around the world. Roche will now have millions of tests available per month to run on the machines, the company said.
Elsewhere, Mayo Clinic said it has developed a SARS-CoV-2 test with a 24-hour turnaround time. Becton Dickinson (NYSE:BDX) said today it will submit an emergency use authorization request this week to the FDA for a coronavirus test that could be used on the BD Max molecular diagnostic system.
On Sunday, the FDA re-issued an emergency use authorization to the Centers for Disease Control for its COVID-19 diagnostic test with amendments to help expand test and component availability and reduce the time to final results.
Here’s a roundup of other companies’ work in testing for and treating patients with the virus or helping healthcare providers to do so:
Vikor Scientific said today that is in the process of validating a COVID-19 test to be released this week pending FDA approval. The testing will be conducted via the QuantStudio 12K Flex open array from Thermo Fisher, according to Vikor, a high-complexity, CLIA-certified and CAP-accredited laboratory in Charleston, S.C. QuantStudio has the capacity to process tests from a high volume of patients daily, according to Vikor.
Advaite (Chester Springs, Pa.) announced today that it will begin supplying the global market with its COVID-19 rapid-response diagnostic testing kits, Advaite RAPCOV. The test uses immunochromatography technique to highlights the presence of anti-COVID-19 IgM and IgG antibodies in their specific bands and verifies the validity of the test with a third control band, according to the company. Based on the presence or absence of IgM and IgG antibody bands, the COVID-19 rapid response test provides presumptive differentiation between recent and past infections.
Chicago-based Surgisphere said it has a rapid diagnostic tool for novel coronavirus available. The tool uses as few as three common laboratory tests to identify patients likely to have coronavirus infection, the company said. With a sensitivity of 93.7% and specificity of 99.9%, this highly accurate test can help limit transmission of this deadly virus by identifying and isolating affected patients sooner, mobilizing appropriate public health resources, and avoiding the delays associated with current testing.
Rapid Dx for Life (Reno, Nev.) said it will be deploying several Rapid Dx mobile diagnostics labs in the U.S., Canada, and Africa in the coming days. Planning is in progress to test healthcare staff, hospital patients, seniors 60 years or older and plus immune-compromised patients.
CytoSorbents (OTC:CTSO) is touting its CytoSorb blood purification technology to treat life-threatening complications of COVID-19 infection, such as acute respiratory distress syndrome, shock, kidney failure, acute cardiac injury and secondary bacterial infections. Although CytoSorb does not kill or remove the virus, it can help get these out of the ICU faster, according to the the Monmouth Junction, N.J.-based company. CytoSorb is approved in the European Union and distributed in 58 countries around the world. It is not yet approved in the U.S.
EarlySense (Woburn, Mass.) said Israel’s Sheba Medical Center is using the company’s contact-free, continuous monitoring system to help protect staff while monitoring isolated patients suspected of coronavirus exposure. EarlySense’s system tracks respiratory rate, heart rate and movement without touching the patient. The sensor, placed under the patient’s mattress, transmits real-time patient data for the early detection of clinical changes to a display outside of the patient’s room. There are no leads or other wearable devices to adjust or to touch the patient’s body.
PreCheck Health Services announced its third distribution agreement for Co-Diagnostics’ Coronavirus COVID-19 test. A PreCheck subsidiary will distribute the test and Co-Dx Box in Panama. This agreement follows the execution of exclusive distributions agreements with Co-Diagnostics for Russia and Ecuador.
Novacyt also announced last week that it launched a COVID-19 test developed by its molecular diagnostics division Primerdesign. The company said it sold and received orders for over €4.3 million of its tests.