PerkinElmer Inc. (PKI) tops the list of molecular diagnostic tests for Covid-19 based on its ability to detect the smallest amount of virus, according to a report from the Food and Drug Administration.
The FDA listed each diagnostic's limit of detection, a number describing the lowest amount of virus particles in a sample that could still provide a correct test result, reported FierceBiotech. The samples are measured in the number of individual units of RNA detectable by nucleic acid amplification, per milliliter. The lower the number, the better.
PerkinElmer's coronavirus detection kit scored 180. Its nearest competitors—by about a factor of three - were all in the 540 to 600 range. These tests are from Hologic Inc. (HOLX), Korean company BioCore Co. (XKRX:216400) and privately held ScienCell Research Laboratories DiaCarta and Seasun Biomaterials.
A molecular test identifies the genetic material of the virus using a lab technique called polymerase chain reaction. With a PCR test, a health care worker collects fluid from a nasal or throat swab or from saliva. Results may be ready on the spot if analyzed onsite or a few days or longer if sent to an outside lab.
The other type of test is called an antigen test. This Covid detector finds certain proteins in the virus using a nose or throat swab to get a fluid sample. Results may be available in a matter of minutes. This test is faster and cheaper and as a result, is more practical to use to test large numbers of people.
Molecular tests should dominate the field in 2020, accounting for two of every three tests, according to Grandview Research. They estimate the global market for all Covid diagnostics at nearly $20 billion this year, growing at a compound rate of more than 3% through 2027.
PCR tests with limits of 1,800 were those developed by Becton, Dickinson and Co. (BDX), Quest Diagnostics Inc. (DRG), Roche (RHHBY) and Helix. Abbott Laboratories' (ABT) RealTime assay and Cepheid's (CPHD) Xpert Xpress rapid point-of-care test came in at 5,400.
Rounding out the list at 180,000 were Diatherix Eurofins, Luminex Corp. (LMNX) and Qiagen N.V. (QGEN).
The FDA put out a separate list for point-of-care screening tests using dry collection swabs and no viral transport media. They include Abbott's ID NOW test, with a limit of detection of 300,000, and Quidel Corp.'s (QDEL) Lyra Direct assay at 540,000. The FDA also posted data from Fluidigm Corp (FLDM), whose saliva test hit 54,000.
Disclosure: The author has no position in any of the stocks mentioned in this article.
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