FDA BRIEF: Week of July 18, 2016

FDA approved

QUANTIDE X qPCR BCR-ABL IS Kit

Asuragen, Inc., Austin, TX, USA

INDICATION FOR USE:

In vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QuantideX qPCR BCR-ABL IS Kit is a reverse transcription-quantitative PCR performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML.

UNMET NEED:

  • CML rare disease due to a genetic abnormality that produces the BCR-ABL gene (also known as the Philadelphia Chromosome) not found in normal cells
  • 8,220 estimated new CML cases in 2016; 1,070 estimated deaths
  • Need for BCR-ABL testing as a tool for clinicians to manage CML treatment

REG PATHWAY: De Novo, Regulation Number: 21 CFR 866.6060,  Class II, Product Code: OYX. First nucleic acid-based quantitation test for use during treatment of CML patients

DESCRIPTION: Kit uses blood specimens from patients with CML to measure the amount of BCR-ABL, which can be used to estimate the amount of leukemia cells in a patient when treated with BCR-ABL targeted therapies.

EFFECTIVENESS:

  • Study using banked samples across three U.S. clinical laboratories (n=98)
  • Significant difference in patient outcomes who achieved reduced levels of BCR-ABL from targeted therapy from those who did not

RISKS: False negative results, False positive results,  Lack of traceability of results

CLASSIFICATION ORDER


 

CARTIVA  Synthetic Cartilage Implant

Cartiva, Inc., Alpharetta, GA, USA

cartiva

INDICATION FOR USE: Treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus

REG PATHWAY:

  • PMA, Product code PNW
  • Positive recommendation by  CDRH Orthopaedic and Rehabilitation Devices Panel
  • Need for post-approval study to demonstrate long-term durability of implant, long-term safety (up to 5 years)

DEVICE DESCRIPTION:

  • Polymer-based biomaterial implant
  • Viscoelastic hydrogel material conducive to replacing focal areas of damaged cartilage, providing pain reduction, and maintaining range of motion
  • Molded cylindrical implant of polyvinyl alcohol and saline that is placed into the metatarsal head in the first metatarsophalangeal (MTP) joint via press-fit implantation
  • Biocompatible material is widely used in other approved medical devices, such as contact lenses
  • Short and minimally invasive implantation procedure
  • Does not regrow or replace cartilage

EFFECTIVENESS:

  • Non-inferiority (15% margin), Single prospective, randomized, controlled multi-center trial (n=202, UK, Canada),  CARTIVA SCI vs. arthrodesis, subjects with painful degenerative or post-traumatic arthritis
  • Composite primary endpoint reflecting pain, function, and safety: Visual Analog Scale (VAS) to assess pain, Foot and Ankle Ability Measure (FAAM) to assess function, absence of major complications and subsequent surgical interventions,  24-month postoperative visit
  • Pain decrease: 89% with Cartiva SCI vs greater pain reduction in control
  • Function improvement and maintenance: >  98% with Cartiva SCI
  • Radiographic success: 100% with Cartiva SCI
  • Freedom from Subsequent Secondary Surgical Interventions: 90% with Cartiva

SAFETY:

  • Device related adverse event at 24 months : 15.1% with Cartiva vs. 8.0%
  • Serious device related adverse event at 24 months:  7.2%; vs 4.0%
  • Bony Reaction, Heterotopic Ossification

PATIENT PERSPECTIVES:

  • Patient Satisfaction question, “My overall well-being has improved since the beginning of the study?”
  • “strongly agree” or “agree” was 76% and 74% at 12 and 24 mo. with Cartiva SCI

LABEL


 

 

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