FDA BRIEF: Week of November 27, 2017

Capture.JPGFOUNDATIONONE CDx (F1CDx), in vitro diagnostic Test 

Foundation Medicine

INTENDED USE:
Next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type

ADDRESSING UNMET NEED:

  • Run of one test to evaluate several appropriate disease management options
  • Avoids invasive process of extracting tumor samples multiple times
  • Help cancer patients and their health care professionals make more informed care decisions- eligibility for a single treatment or enrollment in a clinical trial

DESCRIPTION:

  • Sequencing DNA from patient’s tumor sample to determine the presence of gene mutations and alteration
  • Also detects certain molecular changes (microsatellite instability and tumor mutation burden)

CLINICAL PERFORMANCE: 

  • Established through least burdensome means by comparing F1CDx to previously FDA-approved companion diagnostic tests
  • F1CDx ability to detect select mutation types (substitutions and short insertions and deletions) representative of the entire 324 gene panel is accurate approximately 94.6% of the time
  • Provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer
  • Additionally, based on individual test results, can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options
  • One test report to patients and health care professionals; avoiding duplicative biopsies

REGULATORY PATHWAY: PMA

  • First device with the FDA’s Breakthrough Device designation
  • Coordinated, cross-agency approach; CDRH conducted clinical review with support from the FDA Oncology Center of Excellence

REIMBURSEMENT PATHWAY:  National Coverage Determination (NCD)

  • CMS provides coverage of NGS IVD tests to assist patients and their treating physicians in making informed cancer treatment decisions that improve health outcomes
  • Use of test as a diagnostic also help patients and their treating physicians determine candidacy for cancer clinical trials

PARALLEL REGULATORY-REIMBURSEMENT PATHWAY: 

  • FDA-CMS Parallel Review Program
  • Open to certain PMA applications for devices with new technologies and fall within the scope of a Part A or Part B Medicare-benefit category; have not been subject to NCD
  • CMS issued a proposed national coverage determination concurrent with FDA approval

Federal Register: Program for Parallel Review of Medical Devices


CaptureRHA® 2, RHA® 3, and RHA® 4 Dermal Fillers

Teoxane SA

INDICATION FOR USE:

 

  • RHA® 2 is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older
  • RHA® 3 is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older
  • RHA® 4 is indicated for injection into the deep dermis to superficial subcutaneous tissue for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older

REGULATORY PATHWAY: PMA

  • Product Code : LMH (Implant, Dermal, For Aesthetic Use)

DEVICE DESCRIPTION :

  • Viscoelastic, sterile, non-pyrogenic, clear, colorless, biodegradable gel devices
  • Produced with sodium Hyaluronic Acid (NaHA) using  Streptococcus equibacterial strain, crosslinked with 1,4-butanediol diglycidyl ether (BDDE)
  • Contain 0.3% lidocaine hydrochloride to reduce pain on injection
  • Exist in three formulations, from the least to the most cross-linked:  RHA® 2 (least cross-linked), RHA® 3,  RHA® 4 (most cross-linked)

EFFECTIVENESS:

  • 2 controlled, randomized, double-blinded, within subject (split-face), multicenter, prospective clinical studies; RHA vs non-treatment group, 15 months
  • Noninferioriority to respective control at 24 weeks after treatment, for the correction of NLF
  • Wrinkle Severity Rating Scale: Average improvement in the WSRS from preinjection was ≥ 1-grade
  • Improvement in Patient perspectives: Global Aesthetic Improvement (GAI),  FACE-Q, patient satisfaction survey

SAFETY:

  • No reports of deaths, Treatment-Related Serious Adverse Events or Unexpected Adverse Device Effects in the study
  • All Treatment-Related Adverse Events were typically experienced following the injection of a dermal filler

LABEL


CaptureTRIVISC (Sodium Hyaluronate ) injection

OrthogenRx

INDICATION:   Treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen)

REGULATORY PATHWAY: PMA

 

  • Product Code: MOZ

DESCRIPTION:

  • Sterile, viscoelastic, non-pyrogenic solution of purified, high molecular weight sodium hyaluronate, derived from a bacterial fermentation process
  • Sodium hyaluronate is a polysaccharide containing repeated disaccharide units of glucuronic acid and N-acetylglucosamine
  • TriVisc is supplied in a 3 mL glass syringe; sterile and non-pyrogenic

EFFECTIVENESS & SAFETY:

  • Adequate evidence of the sufficient similarity of TriVisc and VISCO-3™ with regard to chemical constituents, concentrations of constituents, solution characteristics, and molecular weight profiles of the sodium hyaluronate component
  • Application of FDAMA Section 216 to confirm evidence presented support reasonable assurance of its effectiveness of VICSO-3 is directly applicable towards
    establishing reasonable assurance of the effectiveness of TriVisc

LABEL


Image Credits: Foundation Medicine, Teoxane, OrthogenRx 

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