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FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway

by | Jan 16, 2018 | Essential, FDA-lir, Industry Buzz-lir, Laboratory Industry Report

From - Laboratory Industry Report A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including… . . . read more

A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including:

  • FoundationOne’s CDx (F1CDx) companion diagnostic test for solid tumors; and
  • Memorial Sloan Kettering Cancer Center’s Integrated Mutation Profiling of Actionable Cancer Targets tumor profiling test assay (MSK-IMPACT).

Of course, FDA approval of next-generation sequencing-based (NGS) personalized medicine cancer assays is always a pretty big deal for the diagnostics community. But these developments may have an even deeper significance to the extent they offer clues on the agency’s wider approach to approval of laboratory-developed tests (LDTs) going forward.

The Approved Products
MSK-IMPACT is a 468-gene panel detecting genetic mutations in rare and common cancers. Data Profile: According to the agency, the data demonstrated that the assay is highly accurate (over 99%) and capable of detecting a mutation at a range of 2% to 5%. percent to 5 percent). Additionally, the test could detect microsatellite instabilities 92% of the time across multiple cancer types in 175 cases, when compared to traditional detection methods.

F1CDx can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. Data Profile: The FDA found that the data demonstrated the test’s ability to detect select mutation types with 94.6% accuracy. Of course, this isn’t the first companion diagnostic the agency has approved. However, rather than match one test to one drug the way all previously approved tests do, F1CDx enables matching of patients with five different tumor types to 15 different approved, targeted treatments, including those for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, or ovarian cancer.

The Approval Pathways
The story is not just that both tests were approved but also how they were approved.

MSK-IMPACT became the first comprehensive tumor-profiling LDT to receive FDA authorization through the de novo premarket review pathway. It had previously been approved by the New York State Department of Health as a laboratory-developed clinical test. The FDA authorized MSK-IMPACT as a Class II, moderate-risk device, which enables subsequent, similar types of tests to use the FDA’s less onerous 510(k) clearance pathway.

F1CDx, meanwhile, was approved by the FDA in concert with the CMS under the Parallel Review Program designed to speed up adoption of innovative technologies by allowing for tests to receive FDA approval and immediate Medicare coverage determination simultaneously. The Parallel Review Program is open to certain premarket approval applications for new device technologies that fall within Medicare’s Part A or Part B benefit categories. A final coverage decision is expected in the first quarter of 2018, at which time F1CDx will be made commercially available. Analysts say that simultaneous FDA approval and Medicare coverage could also have a positive impact on private reimbursement decisions.

Other New FDA Approvals
Meanwhile, here’s a rundown of the other key new approvals issued by the FDA in mid-November through December:


Manufacturer(s) Product(s)
Foundation Medicine Approval of FoundationOne CDx (F1CDx), NGS-based genomic profiling test
Memorial Sloan Kettering Cancer Center Approval of MSK-IMPACT NGS tumor profiling assay
Quidel Approval of assay to detect Group B Strep using firm’s Solana molecular system
Quidel Approval and CLIA waiver for assay to detect Group A Strep on firm’s Sofia 2 fluorescent immunoassay analyzer
Beckman Coulter Diagnostics Approval of automated Access AMH test for quantitative determination of anti-Müllerian hormone levels
Ortho Clinical Diagnostics Approval of Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Vitros 3600 Immunodiagnostic System
Microgenics Approval of CEDIA Heroin Metabolite Assay for detecting presence of heroin metabolite in urine
Siemens Healthineers Approval of:

  • N Latex FLC kappa assay
  • N latex FLC lambda assay
  • N FLC standard SL
  • N FLC Control SL1 and SL2
DxNA Approval of GeneSTAT.MDx Coccidioides test for valley fever
Lia Diagnostics Approval of Lia Pregnancy Test, making it the first FDA-cleared, flushable, biodegradable pregnancy test, according to the company
Hologic Approval of Panther Fusion AdV/hMPV/RV respiratory assay for running on firm’s Panther Fusion system
Sysmex America Approval and CLIA waiver for XW-100 Automated Hematology Analyzer, a complete blood cell count test, for use in health care settings such as doctors’ offices and clinics
GenePOC Approval of GenePOC CDiff test detecting the toxin B gene of toxigenic C. diff strains directly from stool samples
Grifols Approval of blood-based alpha-1 antitrypsin (AAT) deficiency test

In December, the FDA granted CLIA waivers to the following test kits:


Manufacturer(s) Product(s)
Alere Alere, BinaxNOW Influenza A & B Card 2 {With Reader} (Direct Nasal and NP Swabs)
Quidel Quidel Sofia 2 (Sofia RSV FIA)
Quidel Quidel Sofia 2 (Sofia Influenza A+B FIA)
Sysmex America XW-100 Automated Hematology Analyzer

New CE Marks & Global Certifications
Notable European CE certifications:


Manufacturer(s) Product(s)
Epigenomics Approval of Epi proLung blood-based lung cancer test
BGI Approval of NIFTY cell-free DNA-based noninvasive prenatal test kit for fetal chromosomal aneuploidies on BGISEQ-500 platform
Bio-Rad Laboratories Approval of QXDx BCR-ABL %IS Kit to detect BCR-ABL gene fusions
Vela Diagnostics Approval of Sentosa SX Cell-free DNA Kit is now CE marked for running on Sentosa SX101 instrument
Biocartis Approval of two liquid biopsy tests to detect RAS mutations in circulating tumor DNA from patients with metastatic colorectal cancer:

  • Idylla ctNRAS-BRAF Mutation Test
  • Idylla ctKRAS Mutation Test

Other key international clearances included World Health Organization approval of Atomo Diagnostics’ Atomo HIV Self Test, an HIV self-test that is now eligible for procurement by organizations that can access Global Fund and Unitaid resources.

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