Breast Implant-associated Anaplastic Large Cell Lymphoma Diagnostic Test

Breast Implant-associated Anaplastic Large Cell Lymphoma has prompted the FDA to require black box warnings on breast implants.A lateral flow assay test has been developed to detect cytokines that predict BIA-ALCL.Point of care diagnostic test provides…
  • Breast Implant-associated Anaplastic Large Cell Lymphoma has prompted the FDA to require black box warnings on breast implants.
  • A lateral flow assay test has been developed to detect cytokines that predict BIA-ALCL.
  • Point of care diagnostic test provides results in 60 seconds for early detection.

Abstract:

Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare cancer of the immune system, not breast cancer. BIA-ALCL has primarily been associated with textured implants, but there have been a few cases reported with smooth implants. The rates of reported disease is low, but may be under reported. Several implants have been pulled from the market and FDA now requires a black box warning, it's most stringent of warnings, on all implants. BIA-ALCL normally presents 7-10 years post implant and with over 10 million implants globally, there is a large population that may require accurate testing. Expression of IL-9, CD30 and other associated cytokines in the seroma of BIA-ALCL patients serve as a diagnostic marker for BIA-ALCL and possibly identify its benign cellular precursor. A lateral flow assay has been developed and optimized to detect these cytokines in under 60 seconds. This point of care diagnostic can be performed from a simple aspiration biopsy of the fluid surrounding the implant allowing for early detection and patient peace of mind.

Website:

https://iu.flintbox.com/technologies/9B576691ECB94D3380E54D7C421D84E3

Advantages:

The rates and mortality rates of BIA-ALCL may be low, but because of the late disease presentation and the sheer number of implants globally, the need for an accurate, low-cost diagnostic test exists. ALCL cannot be diagnosed by normal screening and no rapid diagnostic test currently exist. This point of care diagnostic test would replace the need of dedicated lab equipment.

Potential Applications:

Anaplastic Large Cell Lymphoma Diagnostic

Contact Information:

שֵׁם : Tyson Rugenstein

אימייל : trugenst@iu.edu

טלפון : 317-278-1916