FDA Watch: New Moves to Boost CLIA Transparency
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA’s primary role in the CLIA system is to categorize IVDs. Test Category Get CLIA Certificate Meet Quality Standards Submit to Routine Inspections Moderate complexity ✔ ✔ ✔ High complexity ✔ ✔ ✔ Waived ✔ On Oct. 2, the FDA did two things to enhance the transparency of its CLIA activities. 1. Revised Categorization Guidance The FDA issued updated guidance providing more details about the procedures it will use to categorize IVDs and respond to applications for CLIA waivers. The key details: The FDA will try to notify sponsors of an approved IVD’s categorization within two weeks of approval; IVDs approved for home or over-the-counter use will be waived automatically; Makers of IVDs categorized as moderate complexity can apply for a CLIA waiver; To get the waiver, the maker must use clinical and flex studies to show that the test is simple to use and poses "insignificant risk of an erroneous result." 2. Publication of CLIA Waivers The second thing the FDA did to beef up transparency is launch a pilot program under which it will publish summaries […]
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs.
| Test Category | Get CLIA Certificate | Meet Quality Standards | Submit to Routine Inspections |
| Moderate complexity | ✔ | ✔ | ✔ |
| High complexity | ✔ | ✔ | ✔ |
| Waived | ✔ |
On Oct. 2, the FDA did two things to enhance the transparency of its CLIA activities.
1. Revised Categorization Guidance
The FDA issued updated guidance providing more details about the procedures it will use to categorize IVDs and respond to applications for CLIA waivers. The key details:
- The FDA will try to notify sponsors of an approved IVD's categorization within two weeks of approval;
- IVDs approved for home or over-the-counter use will be waived automatically;
- Makers of IVDs categorized as moderate complexity can apply for a CLIA waiver;
- To get the waiver, the maker must use clinical and flex studies to show that the test is simple to use and poses "insignificant risk of an erroneous result."
2. Publication of CLIA Waivers
The second thing the FDA did to beef up transparency is launch a pilot program under which it will publish summaries of its CLIA Waiver by Application (CW) decisions. In addition to enabling the public to see how the FDA reviewed the data, publishing the decision summaries will help test makers prepare their future CW applications, according to the agency.
NOTE TO USERS: To keep you abreast of FDA CLIA waivers, LIR will include CW decision summaries in the monthly FDA Watch column from now on.
Here's a rundown of the other key diagnostic product launches from late August through the third week of September.
A Zika Approval First
On Oct. 6, Roche's Cobas test for detecting Zika virus in plasma specimens of human blood and organ donors the first Zika detection test approved for use by blood collection facilities in screening blood supplies. Although the FDA has issued about two dozen emergency use authorizations for Zika assays, including two new EUAs this month (see chart below), it has yet to greenlight any Zika test for actually diagnosing patients.
Here's a look at key FDA diagnostics approvals in late September through mid-October:
NEW FDA APPROVALS
| Manufacturer(s) | Product(s) |
| Hologic | Approval of Panther Fusion Flu A/B/RSV assay running on Panther Fusion system |
| Cepheid | Approval of Xpert Xpress Strep A test is an automated real-time PCR assay for rapid detection of Streptococcus pyogenes in DNA from throat samples |
| Alere | Approval of Alere i Influenza A & B 2 test for rapid detection of influenza A and B infection |
| Chembio Diagnostics | Emergency use authorization for DPP Zika System for use in high- and moderate-complexity CLIAcertified labs |
| Roche | Approval of Cobas Zika test for detecting the virus in blood donations |
| Roche | Approval of Cobas Cdiff Nucleic acid test for detecting toxin B gene of toxigenic Clostridium difficile |
| Roche | Expanded approval of Ventana PD-L1 assay for use in non-small cell lung cancer and metastatic urothelial carcinoma in countries that recognize CE marking and have approved Roche's Tecentriq cancer immunotherapy |
| Sanguina | Approval of AnemoCheck assay for determining total hemoglobin and calculated hematocrit in whole blood |
| Siemens Healthcare Diagnostics | Emergency use authorization for Advia Centaur test for qualitative detection of Zika virus IgM antibodies in human serum and plasma |
| Agilent Technologies | Expanded approval of Dako PD-L1 IHC 28-8 pharmDx complementary diagnostic for use as companion diagnostic with Merck's Keytruda drug for 2 additional indications: urothelial carcinoma and squamous cell carcinoma of the head and neck |
| Agilent Technologies | Approval of GenetiSure Dx Postnatal Assay to detect genetic aberrations associated with developmental delay and intellectual disabilities |
So far, the FDA has published two CLIA waiver summary decisions.
NEW FDA CLIA WAIVERS
| Manufacturer(s) | Product(s) |
| Quidel | Waiver for Sofia RSV FIA test for use with Sofia analyzer |
| Quidel | Waiver for Sofia Influenza A+B FIA test for use with Sofia analyzer |
New CE Marks & Global Certifications
Here's a summary of notable European CE certifications during the month:
So far, the FDA has published two CLIA waiver summary decisions.
NEW FDA CLIA WAIVERS
| Manufacturer(s) | Product(s) |
| Atomo Diagnostics | Approval of Atomo HIV Self Test |
| Abacus Diagnostica | Approval of molecular norovirus test |
| Bruker | Approval of Fungiplex Candida assay |
| Bruker | Approval of Micronaut-AM test plate |
| Hibergene | Approval of HG Meningococcus Direct CSF test |
| Siemens Healthineers | Approval of Atellica Solution platform |
Other new international approvals included approval of Gencurix's GenesWell ddEGFR Mutation Test for use as a companion diagnostic by the South Korean Ministry of Food and Drug Safety.
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