Navigation Links
AMP releases statement on oversight of laboratory tests
Date:1/28/2010

Bethesda, MDJanuary 28, 2010 Today, the Association for Molecular Pathology (AMP) released its new position statement on the oversight of laboratory developed tests (LDTs), a recent focus of debate among policy makers, the laboratory community and other stakeholders. AMP's statement outlines the organization's commitment to providing high quality tests and its recognition of the need for implementation of appropriate oversight mechanisms. The association also met with officials from the United States Food and Drug Administration tasked with reviewing applications for diagnostic devices to inform them of the new position statement and discuss FDA's approach to regulating tests.

In recent years, there has been increased attention on the oversight of LDTs among policy makers, manufacturers, regulators and the laboratory community. While AMP believes that current mechanisms are sufficient in ensuring patient safety and broad access to high quality tests, AMP is taking this opportunity to elucidate its position on the issue.

"We believe that laboratory developed tests are an essential and central component of clinical care," said AMP President Dr. Karen Mann. She continued, "There is no evidence that the current oversight system has been inadequate or that there have been systemic problems."

In its position statement, AMP highlights that laboratories performing molecular tests are subject to the Clinical Laboratory Improvement Amendments and all laboratory directors are extensively trained professionals who adhere to all training requirements, certifications, licensure, and other regulations. Dr. Mann stressed the need to foster innovation, "As policymakers, regulators, and other stakeholders consider modifying the current oversight process, AMP urges them to ensure continued patient access to testing." AMP calls for stakeholders to avoid proposals that would hinder innovation in diagnostics, slow the rapid development and modification of necessary tests and impede the practice of medicine as all specialties rely on diagnostic tests.

AMP's specific recommendations include:

  • Laboratory directors or medical directors should review and reaffirm their policies and procedures for reviewing and documenting that appropriate validation studies have been performed for all tests developed in their laboratories with due consideration of clinical utility and clinical utilization.
  • CLIA should reassess utilization of resources and enforcement capabilities in order to meet its current mandate. CLIA should strengthen its enforcement capabilities by hiring more inspectors and improve the training of its inspectors.
  • To increase transparency, CMS should make information collected from laboratories in the CLIA program available and easily accessible to the public and other regulators.
  • Proficiency testing is a requirement of certification. When a formal proficiency testing program is not available, laboratories must perform and document alternative assessments as directed by CLIA.
  • Some tests may require greater scrutiny, such as those with hidden or nontransparent algorithms, and should be subject to additional review by regulators.
  • All LDTs should be subject to the same oversight mechanisms, and molecular tests should not be unduly scrutinized.
  • Any changes to the current oversight system should occur after a formal rule making process or statutory change.


'/>"/>

Contact: Mary Steele Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

Related biology news :

1. Toxic releases down from North American industry leaders, increasing from other facilities
2. University of Minnesota releases first ever comprehensive report of the health of college students
3. WHRC releases 4 key reports
4. DOE JGI releases soybean genome assembly to enable worldwide bioenergy research efforts
5. DOE JGI releases a new version of its metagenome data management and analysis system
6. Wildlife Conservation Society releases definitive state of the wild
7. Pioneering landscape-scale research releases first findings
8. EPA releases science assessment on health effects of nitrogen oxides
9. EPA releases report on climate change and health
10. Neurotechnology Releases SentiSight 2.0 SDK Universal Object Recognition Technology
11. Neurotechnology Releases SentiSight 2.0 SDK Universal Object Recognition Technology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/22/2016)... WASHINGTON , June 22, 2016 On ... highly-anticipated call to industry to share solutions for the ... by U.S. Customs and Border Protection (CBP), explains that ... nationals are departing the United States ... criminals, and to defeat imposters. Logo - ...
(Date:6/15/2016)... June 15, 2016 Transparency ... titled "Gesture Recognition Market by Application Market - Global Industry Analysis ... 2024". According to the report, the  global gesture recognition ... 2015 and is estimated to grow at a ... by 2024.  Increasing application of gesture ...
(Date:6/3/2016)... , June 3, 2016 ... Management) von Nepal ... und Lieferung hochsicherer geprägter Kennzeichen, einschließlich Personalisierung, ... führend in der Produktion und Implementierung von ... der Ausschreibung im Januar teilgenommen, aber Decatur ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... June 27, 2016 , ... Rolf K. Hoffmann, ... faculty of the University of North Carolina Kenan-Flagler Business School effective ... at UNC Kenan-Flagler, with a focus on the school’s international efforts, leading classes ...
(Date:6/24/2016)... Epic Sciences unveiled a liquid biopsy ... PARP inhibitors by targeting homologous recombination deficiency (HRD) ... test has already been incorporated into numerous clinical ... Over 230 clinical trials are investigating ... PARP, ATM, ATR, DNA-PK and WEE-1. Drugs targeting ...
(Date:6/23/2016)... ... 2016 , ... UAS LifeSciences, one of the leading manufacturers ... Probiotics, into Target stores nationwide. The company, which has been manufacturing high quality ... list of well-respected retailers. This list includes such fine stores as Whole Foods, ...
(Date:6/23/2016)... , June 23, 2016 Houston Methodist ... the Cy-Fair Sports Association to serve as their ... agreement, Houston Methodist Willowbrook will provide sponsorship support, ... connectivity with association coaches, volunteers, athletes and families. ... the Cy-Fair Sports Association and to bring Houston ...
Breaking Biology Technology: