As the COVID-19 epidemic has intensified, diagnostic manufacturers have rushed to develop tests for SARS-CoV-2, leading to an unprecedented flood of diagnostic regulatory authorizations. In the U.S., Cepheid’s Xpert Xpress SARS-CoV-2 test and Abbott’s ID NOW COVID-19 test became two of the first rapid point-of-care tests for the virus to earn Food and Drug Administration (FDA) emergency use authorizations (EUA). Other companies that had received FDA EUAs for SARS-CoV-2 tests at the time CLN went to print include LabCorp, Quest, Hologic, bioMérieux, PerkinElmer, Luminex, Quidel, BGI Americas, Sentinel Diagnostics, Primerdesign, DiaSorin, GenMark, and Avellino Labs. Almost all of the tests that FDA has authorized so far are molecular assays, but serological tests are also starting to come to market, such as Diazyme’s DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA test kits. Additionally, the Centers for Disease Control and Prevention (CDC) qualified and approved primer and probe kits manufactured by LGC, Biosearch Technologies and Integrated DNA Technologies that are designed for labs implementing CDC’s SARS-CoV-2 test.

While an inability to test widely hamstrung the U.S.’s initial response to COVID-19, this sudden profusion of SARS-CoV-2 tests has not been without its drawbacks. In particular, FDA has needed to caution consumers against using unauthorized, fraudulent test kits that some companies are marketing as at-home tests for COVID-19.

Outside the U.S., Thermo Fisher, BGI, DiaCarta, AusDiagnostics, Bioneer, 3-Dmed, Genomica, Osang Healthcare, Co-Diagnostics, Vision Medicals, Credo Diagnostics, a collaboration between CerTest and BD, and SolGent have all received the CE mark for their SARS-CoV-2 tests. SolGent’s test also received EUAs from Korean and Philippine regulatory authorities. Elsewhere in Asia, Fosun Long March and Rendu Biotechnology earned Chinese regulatory approval for their tests, while an assay developed by the Agency for Science, Technology, and Research and Tan Tock Seng Hospital gained provisional authorization from Singapore.

FDA Releases Guidance to Aid Manufacturers Applying for CLIA Waivers

The Food and Drug Administration (FDA) has finalized two guidance documents related to CLIA waiver submissions. The first guidance, “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices,” provides an update to FDA’s 2008 guidance for manufacturers who are submitting CLIA waiver applications. Specifically, in compliance with the 21st Century Cures Act, FDA revised Section V of the 2008 CLIA Waiver Guidance to include the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate device accuracy.

The second new guidance, “Recommendations for Dual 510(k) and CLIA Waiver by Application Studies,” includes recommendations for designing a single set of comparison and reproducibility studies that may support dual 510(k) clearance and CLIA waiver submissions. With this guidance, FDA hopes to increase use of the agency’s Dual 510(k) and CLIA Waiver by Application pathway in order to expedite the process of bringing new in vitro diagnostic tests to CLIA-waived settings.

FDA Approves Roche Test for Triaging HPV-Positive Screening Results

Roche has received Food and Drug Administration approval for the CINtec PLUS Cytology, making this the first commercially available biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using Roche’s cobas 4800 HPV test. While most HPV infections resolve on their own, some women who test positive for the virus or whose co-testing results are inconclusive—HPV-positive and Pap cytology-negative—develop pre-cancerous cervical lesions that, if left untreated, progress to cervical cancer. The CINtec PLUS Cytology test identifies those women whose HPV infections are most likely to progress in this manner and who would benefit from immediate referral to colposcopy versus repeat testing. The test detects the simultaneous presence within a single cell of the two biomarkers p16 and Ki-67, an abnormality that is associated with HPV infections that are transforming. Additionally, labs can perform the test using the same liquid sample that is used for HPV or Pap cytology testing. 

CE Mark Given to Randox’s Multiplex STI Assay

Randox Laboratories has earned the CE mark for its cartridge-based sexually transmitted infection (STI) assay, which tests for 10 of the most common STIs: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Treponema pallidum (syphilis), herpes simplex virus 1 and 2, Haemophilus ducreyi, Mycoplasma hominis, and Ureaplasma urealyticum. The test uses Randox’s Biochip Array Technology, which enables simultaneous multi-analyte testing on one undivided sample by combining a panel of related assays on a single biochip with a single set of reagents, controls, and calibrators. The test is performed on the Vivalytic system, a point-of-care platform that Randox developed in partnership with the German technology company Bosch. Randox’s STI test is also fully automated and provides a full molecular workflow, from extraction and polymerase chain reaction amplification through detection. Additionally, it does not require the use of additional peripheral equipment such as a laptop or keyboard, bar-code scanner, or filling stations.

DxTerity Gets CE Mark for At-home Fingerprick Blood Collection Device

The CE mark has been granted to DxTerity Diagnostics for the DxCollect MicroCollection Tube (MCD), which collects and preserves 100 μL of fingerstick blood for DNA- and RNA-based genomic testing. Unlike DNA testing, which can be performed from saliva or a cheek swab, RNA-based genomic testing usually requires a blood sample that is collected into specialized tubes and often shipped on dry ice. The DxCollect MCD stabilizes both DNA and RNA at room temperature, enabling specimens to be shipped under ambient conditions using standard mail. The device has been evaluated in large-scale, direct-to-patient clinical studies.

Following receipt of the CE mark, DxTerity is now focused on gaining Food and Drug Administration approval for the MCD in conjunction with the company’s Modular Immune Profile assay, which is intended for home testing of systemic lupus erythematosus (SLE) patients. DxTerity hopes that regular monitoring of autoimmune patients using the MCD will enable physicians and patients to more effectively manage SLE by predicting potential flare-ups before they happen.