[Congressional Record Volume 143, Number 140 (Thursday, October 9, 1997)]
[Extensions of Remarks]
[Page E1988]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                        FDA APPROVAL OF LEADCARE

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                         HON. MARTIN T. MEEHAN

                            of massachusetts

                    in the house of representatives

                       Thursday, October 9, 1997

  Mr. MEEHAN. Mr. Speaker, I am very pleased to rise today to inform 
the House that on September 10, 1997, the Food and Drug Administration 
announced the approval of a new portable, easy to use, medical 
screening device that can quickly detect high levels of lead in blood. 
The Leadcare In Office Test System was developed by ESA, Inc., of 
Chelmsford, MA, and AndCare, Inc., of Durham, NC, in conjunction with 
the Centers for Disease Control and Prevention.
  Located in my congressional district, ESA, Inc., is a biotechnology 
research company whose products and services have played a significant 
role in advancing the health care of Americans for over a quarter 
century. Since its establishment in 1970, ESA has designed and 
manufactured numerous high technology analytical instruments used for 
analyzing minute quantities of substances, often at the molecular 
level. The company's products are frequently utilized in biomedical 
research projects, clinical laboratories, and environmental quality 
control studies.
  The recently approved Leadcare System promises to dramatically 
improve the rate at which children in the Untied States and abroad are 
screened for lead poisoning. Currently, blood samples from children 
tested for exposure to lead must be sent to a laboratory for clinical 
evaluation. This process could take several days or even weeks. With 
the Leadcare System, a sample of a patient's blood obtained by a finger 
stick can be analyzed by the system within 3 minutes, and the results 
are instantly displayed. Moreover, clinical studies conducted by ESA 
indicate that the new test is as reliable as established laboratory 
screening methods. Both ESA and the Department of Health and Human 
Services believe that the expediency of the Leadcare System will allow 
heath care professionals practicing in urban, underserved areas to 
screen more high-risk children in transient innercity communities.
  The FDA's approval of the Leadcare System is also a major victory for 
the many countries around the world currently losing the battle against 
lead poisoning. Following the FDA's decision, HHS Secretary Donna 
Shalala, stated that ``thanks to the FDA and CDC, and to memorandums of 
understanding we have developed with other countries, this new 
technology can soon be applied to fighting lead poisoning throughout 
many areas of the world.'' To this end, ESA plans to introduce the 
Leadcare System to public health officials and primary care physicians 
in countries with high incidents of lead poisoning.
  Mr. Speaker, the FDA's approval of the Leadcare System is truly a 
landmark in the fight against childhood lead poisoning.

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