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July 2023 FDA Watch

by | Jul 5, 2023 | Essential, FDA-lir, Laboratory Industry Report

Key approvals announced in June represented important steps forward for the lab testing industry.

Roche, Cue Health, and Sysmex Secure Groundbreaking Lab Test Approvals

June was a banner month for lab testing innovation and accessibility in both the US and worldwide, with three key regulatory approvals announced in the first week. Here’s a briefing of the new clearances and their wider significance:

1. Cue Health Gets First De Novo Authorization for At-Home, OTC COVID-19 Molecular Test

Molecular testing is the gold standard for COVID-19 detection, while at-home, over-the-counter (OTC) products are the gold standard for making testing widely available. Combining the two into a single test was thus a priority for some companies during the recently concluded COVID-19 public health emergency (PHE), when the FDA cleared four such tests, but only on an emergency basis.1

One of those tests was Cue Health’s Cue COVID-19 Molecular Test, which received Emergency Use Authorization (EUA) in March 2021. The three other molecular, at-home OTC tests granted EUA include Lucira Health’s CHECK-IT COVID-19 Test Kit, Aptitude Medical Systems’ Metrix COVID-19 Test, and Pfizer’s Lucira by Pfizer COVID-19 & Flu Home Test.

On June 6, the FDA announced that the Cue test had become the first molecular, at-home COVID-19 OTC test to take the next step to long-term consumer access by obtaining full premarket authorization through the De Novo pathway. Bringing rapid and accurate molecular COVID-19 testing to the home setting is no small accomplishment, according to the FDA. The FDA’s Center for Devices and Radiological Health (CDRH) director Jeff Shuren, MD, JD, described the authorization as “representing a new era of consumer access to diagnostic tests that can be performed entirely at home.” He added the approval illustrates “the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions.”2

San Diego-based Cue Health developed the technology on which the test is based with the help of federal funding from the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response and Biomedical Advanced Research and Development Authority under a contract awarded in June 2018.3

2. Roche Wins WHO Prequalification for HPV Test

Roche took a step to boost its leading position in the nearly $2 billion global human papillomavirus (HPV) and Pap testing market4 by securing World Health Organization (WHO) prequalification for its cobas® HPV test. Run on Roche’s cobas® 6800/8800 Systems, cobas® HPV detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 associated with cervical cancer. The test has already received CE marking in Europe.5

WHO prequalification is important because many of the world’s low- and middle-income countries (LMICs) use WHO prequalification as a criterion for deciding which lab tests to purchase and make available to their populations. By getting prequalification, the test will be more widely available for use in cervical cancer screening, particularly in LMICs where most cervical cancer deaths occur, according to Roche.

Roche has played an active role in improving access to testing in high-need parts of the world, including via establishing the Roche Global Access Program. “The elimination of cervical cancer is within reach,” noted Roche Diagnostics CEO Matt Sause in the June 13 press release announcing the WHO prequalification. “Today’s action, combined with our recently-launched HPV-self sampling solution, further expands access to HPV screening in countries with limited healthcare resources.”5

3. Sysmex Scores First Japanese Approval for IRD Test

On the other side of the globe, Sysmex Corporation announced on June 5 that its PrismGuide™ IRD Panel System had become the first gene panel testing system for causes of inherited retinal dystrophy (IRD) to secure approval in Japan. The system identifies genes that cause IRD, a group of inherited progressive diseases that includes retinitis pigmentosa, an eye disorder that affects an estimated 1 in 4,000 to 8,000 people, as well as the less common forms of IRD such as Usher syndrome and macular dystrophy, according to Sysmex.6

The system, which Japan-based Sysmex developed with Kobe City Eye Hospital under a joint project began in 2020, is a combination medical device made up of a reagents kit and analysis program. The system is used for “obtaining comprehensive genome profiles” from the blood samples of patients diagnosed with or suspected of having IRD to confirm the presence of the 82 types of genes that cause the disorder. The Sysmex IRD product is the first to receive clearance for the Japanese market.


  1. https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-molecular
  2. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-covid-19-home-test-using-traditional-premarket-review-process
  3. https://cuehealth.com/about/press/cue-health-achieves-groundbreaking-milestone-with-fda:-first-company-to/
  4. https://www.grandviewresearch.com/industry-analysis/hpv-testing-pap-test-market
  5. https://www.roche.com/investors/updates/inv-update-2023-06-13
  6. https://www.sysmex.co.jp/en/news/2023/230605.html


Here are the key new FDA clearances that were announced in June 2023:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s) Product
Michigan State University laboratories, Department of Medicine Olin Student Health Center EUA for In-Dx SARS-CoV-2 RT-LAMP Assay for COVID-19 detection
Diagnostica Stago 510(k) clearance for automated STA R Max3® and STA Compact Max3® coagulation analyzers for clot-based, immunoturbidimetric, and colorimetric testing
Cue Health Cue COVID-19 Molecular Test, first at-home OTC test for COVID-19 to be granted De Novo authorization and first at-home test authorized using a traditional premarket review pathway for any respiratory illness
Foundation Medicine Clearance for FoundationOne® Liquid CDx assay as companion diagnostic to Pfizer’s BRAFTOVI® (encorafenib) in combination with cetuximab for patients with metastatic colorectal cancer to identify BRAF V600E alteration
Acutis Diagnostics EUA for SARS-CoV-2 Acutis Multiplex Assay
BioTeke USA EUA for BIO-SELF™ COVID-19 Antigen Home Test home-use rapid antigen test for COVID-19

New CE Marks & Global Certifications

Notable European CE certifications announced in June 2023:

New Approvals in Europe

Manufacturer(s) Product(s)
Thorne HealthTech NanoDrop instrument for collection of capillary whole-blood samples
DiaSorin LIAISON® B·R·A·H·M·S MR-proADM™ immunodiagnostic assay to assess MR-pro-ADM biomarker released during inflammatory processes and infections
Euroimmun (subsidiary of Revvity) UNIQO 160 fully automated indirect immunofluorescence test benchtop instrument
Seegene 30 assays, including 8 for gastrointestinal infections, 7 for women’s diseases, 5 for respiratory diseases, 4 for tuberculosis, 3 for meningitis, 2 for human papillomavirus (HPV), and 1 for drug resistance
Cepheid (subsidiary of Danaher) Xpert® NPM1 Mutation, RT-PCR assay for acute myeloid leukemia (AML) patients
Eurobio Scientific Three unspecified PCR tests from the company’s EurobioPlex line

Other international clearances announced in June 2023:

Manufacturer(s) Country(ies) Product(s)
Gencurix South Korea Droplex EGFR Mutation Test v2 as companion diagnostic for use with Bio-Rad’s Droplet Digital PCR instrument to identify EGFR mutations in non-small cell lung cancer (NSCLC) patients
Neoteryx (subsidiary of Trajan Scientific and Medical) Australia Remote-use Mitra® blood microsampling instrument and Mitra® Blood Collection Kits for at-home blood sample collection
Roche Countries relying on World Health Organization prequalification Roche cobas® HPV test
Sysmex Japan PrismGuide™ IRD Panel System for identifying genes that cause inherited retinal dystrophy (IRD)
Eurobio Scientific UK Three unspecified PCR tests from the company’s EurobioPlex line

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