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FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal

On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting a new proposal to Congress, officially known as the FDA Technical Assistance (TA) on the Diagnostic Accuracy and Innovation Act (DAIA). The American Clinical Laboratory Association (ACLA), immediately responded by sending members of Congress a 26-page letter outlining lab industry concerns.

ACLA Objections
The thrust of the ACLA’s letter is that the new TA proposes a “distinctly different framework” from the draft of the DAIA negotiated, in part, by a coalition of diagnostic manufacturers and labs in an attempt to create an industry-led solution to the ADLT regulation controversy. The letter raises six specific objections:

  • FDA lacks the legal authority to regulate LDTs;
  • In vitro clinical tests (IVCTs) should be subject to their own regulatory framework separate from medical devices;
  • The FDA’s proposed approach of regulating via guidance rather than specific, binding and definitive regulations is unfair and unacceptable;  
  • The transition provision in the TA could potentially subject IVCTs to regulation “immediately after enactment”;
  • The TA’s grandfathering provision would allow the agency “to ‘claw back’ grandfathered tests at its discretion without basis in meaningful standards”;
    • The FDA’s proposal to eliminate the moderate-risk category for IVCTs will create confusion and may lead to more tests being classified as high risk; and
  • The FDA’s definitions of “analytical validity” and “clinical validity” regarding approval standards are problematic and would give the agency “unprecedented discretion in determining whether an IVCT is analytically or clinically valid.”

New FDA Approvals
Here’s a look at some of the key FDA approvals announced at the end of July through the third week of August

NEW FDA APPROVALS
Manufacturer(s) Product(s)
Roche Approval of Cobas HPV Test as first-line screening test for cervical cancer in women age 25 and older via cervical specimens collected in SurePath preservative fluid
Agilent Technologies Approval of expanded use of Dako PD-L1 IHC 22C3 pharmDx assay as companion diagnostic test for Merck’s anti-PD1 immunotherapy Keytruda for urothelial carcinoma
Techlab 510(k) clearance for H. Pylori Quick Chek rapid detection test for H. pylori
Techlab 510(k) clearance for H. Pylori Chek test for H. pylori on multiple specimens
Grifols Clearance for Procleix Zika Virus blood screening Zika detection assay
Inova Diagnostics Clearance for use of Quanta Flash HMGCR marker to diagnose idiopathic inflammatory myopathy
PapGene Breakthrough Device designation for blood-based cancer diagnostic assay
Siemens Healthineers Clearance for Atellica IM BRAHMS PCT Assay for ER and ICU use of sepsis assessment, assigning mortality risk and antibiotic therapy decision-making
Siemens Healthineers Clearance for use of Dimension Hemoglobin A1c turbidimetric inhibition assay for measuring percentage and mmol/mol measurements of HbA1c in venous whole blood
Siemens Healthineers Clearance of high-sensitivity troponin I assays for use on firm’s Atellica IM and Advia Centaur XP/XPT immunoassay analyzers for early diagnosis of heart attacks
Siemens Healthineers Clearance for use of Advia Centaur CMV IgG quality control material to monitor performance of ADVIA Centaur CMV IgG assay
Hologic Clearance for Group B Streptococcus (GBS) assay on Panther Fusion system
PerkinElmer 510(k) clearance for NeoLSD MSMS kit for screening common lysosomal storage disorders in newborns
PerkinElmer 510(k) clearance for Euroimmun ANCA IFA assay for qualitative or semi-quantitative determination of ANCA of immunoglobulin class IgG in human serum
BioMérieux Clearance for ETest received for determination of antimicrobial susceptibility of non-fastidious gram-negative and gram-positive aerobic bacteria
BioMérieux Clearance for Chromid Carba agar for the detection of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae
Healthy.io 510(k) clearance for Dip.io smartphone-enabled urinalysis kit
Personal Genome Diagnostics Breakthrough Device Designation for PGDx Elio Plasma Resolve cell-free DNA assay
NeuMoDx Molecular 510(k) clearance for the 288 Molecular System high-throughput molecular diagnostics platform
NeuMoDx Molecular 510(k) clearance for GBS Assay Group B Strep test
Quidel Clearance for Solana Bordetella Complete Assay for detecting Bordetella pertussis and Bordetella parapertussis
Abbott Laboratories Clearance for RealTime IDH1 Assay as companion diagnostic to identify patients eligible for Agio Pharmaceuticals’ newly approved Tibsovo (ivosidenib) drug for treating patients with relapsed or refractory acute myeloid leukemia with IDH1 mutations

New CE Marks & Global Certifications
Notable European CE certifications:

NEW CE CERTIFICATIONS IN EUROPE
Manufacturer(s) Product(s)
ProAxsis CE marking for ProteaseTag Active Proteinase 3 immunoassay
Co-Diagnostics CE marking for Logix Smart MTB Test for tuberculosis diagnosis
Xiamen Spacegen PCR

CE marking for 6 kits for detecting:
i. human thyroid carcinoma RET gene fusions
ii. human MGMT gene methylation
iii. human EGFR gene T790M mutation
iv. human pharmacogenomics SNP
v. a human radiotherapeutic side effect-related gene SNP
vi. cardiotoxicity prediction of breast cancer

Ortho Clinical Diagnostics CE marking for Vitros XT 7600 integrated clinical chemistry system

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Tianjin Novogene Bioinformatics Technology China China FDA approval of NovoFocus NSCLC CDx assay Pathology Solution for use as diagnostic tool
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