As of today, 41 laboratory COVID-19 diagnostic tests have been authorized by regulators to identify the virus. In the U.S., these tests are supplied by the CDC for the state and local public health departments and private medical providers are getting tests developed by the commercial manufacturers. The U.S. government did not issue guidance allowing commercial labs to process COVID-19 tests until February 29, 2020, after which the companies began testing within a week.
Currently, 20 COVID-19 diagnostic kits from the U.S. manufacturers have won the emergency use authorization (EUA) from the FDA.
According to the Memorandum on Expanding State-Approved Diagnostic Tests, recently announced by the U.S. President on March 13, the U.S. had authorized each state to have its own responsibility to develop test kits and use them to test patients regardless of the FDA’s approval. Moreover, each state is encouraged to share COVID-19 test results with the FDA.
In the Emergency Use Listing updated by the WHO on March 20, it is understood that apart from the 20 U.S. test kits with an emergency use approval, those made in Korea, Brazil, Singapore, and Australia can also be used. At the same time, the FDA has indicated that the COVID-19 diagnostic products in use in the U.S. and other countries are not “officially” approved, but are available specifically for emergency use. These products will be able to be used until the emergency ends.
Currently, the most common diagnostics approvals are FDA Emergency Authorization and the CE Mark of Approval in Europe.
A breakdown of the 41 approved COVID-19 diagnostic kits are presented below:
- FDA-Emergency Authorization – 20 Kits
- CE Mark of Approval to be sold in Europe – 17 Kits
- Lab Developed Test – 1 Kits
- Discontinued Tests – 3 Kits
(*Note: This includes only diagnostics approved on an emergency basis in the U.S. and Europe on or before April 5, 2020.)
Time Requirements for COVID-19 Tests
After a shaky start, diagnostic testing for COVID-19 has begun to climb up in recent weeks. Commercial labs are demonstrating interest in developing novel tests, drive-up testing sites have been set up in some places, and new types of tests have been approved temporarily under emergency rules set by the FDA. Yet, the turnaround time for the test results varies widely among the different products.
Even by using kits offering <1 hour, it usually gets delayed because it is a multi-step process. The steps include: sample collection, transit to outside laboratories, and processing of the sample. A typical PCR test takes nearly 8 hours to complete the work on a single sample.
Now in the U.S., 94 public health laboratories of the CDC are offering COVID-19 tests.
Moreover, FDA has given “green light” to the huge commercial laboratories to undertake the testing work. According to NBC news, private labs have conducted nearly 1.5 million tests so far, which represents more than 85% of all U.S. tests.
Quest Diagnostics, one of the country’s largest lab companies, has performed and reported the results of approximately 550,000 coronavirus tests since the company began testing on March 9, representing more than one-third of all reported tests. The company can now process up to 35,000 samples per day.
The list below describes the average time required for existing COVID-19 diagnostic tests:
- Less Than 1 Hour – 7 Diagnostic Tests
- 2 to 12 Hours – 23 Diagnostic Tests
- 12+ Hours – 11 Diagnostic Tests
The 41 Companies and their Diagnostic Products
Since the beginning of March, the U.S. FDA has been providing unparalleled flexibility to laboratories and manufacturers to develop and offer COVID-19 tests across the U.S. The agency’s liberal attitude is based on the urgent need for the products. Therefore, the FDA has been very proactive and supportive of test development by laboratories and commercial manufacturers.
In Europe, a CE Mark is required to market diagnostic kits. CE marking is a certification that indicates that a product “conforms with the health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).” Given the extraordinary situation, manufacturers in Europe are looking for fast-track regulatory approval.
As mentioned above, 17 diagnostics kits have been approved thus far for use in Europe.
At-Home COVID-19 Diagnostic Tests
To date, the U.S. FDA has not yet authorized any at-home testing kits for COVID-19, writing in a public warning statement that it “has not authorized any test that is available to purchase for testing yourself at home for COVID-19.” The FDA also wrote that it sees the public heath value in “tests that may include home collection and we are actively working with test developers in this space.”
Regardless, one company pressing forward toward this goal is Scanwell Health, a company best known for its smartphone-based urinary tract infection-screening platform.
On March 20, 2020, Scanwell announced its new at-home COVID-19 diagnostic service. However, the test won’t be available to the public until it receives Emergency Use Authorization (EUA) from the FDA, a timeline which the company hopes will take 6-8 weeks. Scanwell’s serology test has been exclusively licensed from the Chinese firm INNOVITA.
While at-home tests aren’t yet available, home-based testing is ready to be deployed.
Specifically, the company Ready Responders is rolling out its new home-based COVID-19 testing service in Southeastern Louisiana, Reno and Las Vegas. The company’s testing process will involve teleheath support, followed by healthcare professional visiting the home of a patient to assess symptoms, and if appropriate, running an FDA-approved COVID-19 test on site.
Unsurprisingly, the company announced a $48 million Series B round led by Deerfield Management Ventures, in late March.
Recent Diagnostic Tests for COVID-19
New diagnostic tests for COVID-19 are rapidly emerging to track the spread of the disease, because the World Health Organization (WHO) has urged health agencies worldwide to make testing for the virus a top priority.
As recent examples, on March 23, 2020, the FDA granted Cepheid’s Xpert® Xpress SARS-CoV-2 Test “Emergency Use Authorization” (EUA). As an automated molecular test for the detection of the virus, it can provide results in less than 45 minutes.
On March 27, 2020, the U.S. FDA granted EUA to an even faster COVID-19 test from Abbott Laboratories that can provide results in 13 minutes or less. Abbott’s ID NOW COVID-19 Test leverages the company’s existing ID NOWTM platform, the most common point-of-care test in the U.S. that is used to detect other common viruses, such as Influenza A & B, Strep A and respiratory syncytial virus (RSV). It is being scaled to deliver 50,000 tests per day to the U.S. healthcare system.
By March 31, 2020, BD and BioMedomics announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The new test, developed and manufactured by BioMedomics, will be available through BD and distributed exclusively by Henry Schein, Inc. to health care providers throughout the U.S.
On April 2, 2020, Bosch’s Rapid Test was introduced to detect COVID-19 infection in patients in less than two and a half hours. The test can be performed directly at the point of care. It allows a single sample to be tested not just for COVID-19, but also for nine other respiratory diseases, including influenza A and B, simultaneously. The newly developed test has been available in Germany starting in April 2020 and will soon expand to other parts of Europe.
In response to the global swell of COVID-19 cases which have surpassed 1 million worldwide, numerous companies are exploring potential diagnostic tools to support rapid and efficient identification of the virus.
For this reason, BioInformant projects that dozens of diagnostic tests will receive emergency use approvals throughout April and May, with the first at-home kit approved by late May 2020.
To learn more, view the market report, “COVID-19 Global Market Conditions: Pipelines for Diagnostics, Treatments, Cell Therapies & Vaccines.“
What are your thoughts on the newest COVID-19 diagnostic tools? Share them in the comments below.