MEDIA RELEASE
28 OCTOBER 2013
RCPA SUPPORTS FSM RECOMMENDATIONS FOR
PATHOLOGY TESTS IN AUSTRALIA
The Royal College of Pathologists of Australasia (RCPA) has announced its support of a
document released today by Friends of Science in Medicine (FSM) surrounding
Recommendations for Pathology Tests in Australia.
The report outlines a number of proposed recommendations to ensure the accuracy and
reliability of pathology results for diagnosis. It proposes the implementation of regulations
for Non-Medicare funded tests, similar to those already in place for Medicare funded tests,
so that they are measured using a set of characteristics:
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Analytical validity which determines whether the measurement in a test tube accurately
reflects the measurement in the patient’s blood/tissue being analysed;
Clinical validity which determines whether the test result reflects a significant
relationship with the disease in question;
Clinical utility which determines whether the test result reveals additional information
that is not already available; and
Cost-effectiveness of a test, that is, whether the financial cost of the pathology test is
justifiable.
President of the RCPA, Professor Yee Khong, explains that these characteristics, which have
been used for a long time by pathologists to ensure their work is safe and effective, are vital
to appropriate patient care.
“If a patient is making an important health decision based on their pathology results, it is
crucial these tests are of absolute accuracy to ensure correct diagnosis,” says Khong.
The report outlines that individuals may choose to have unvalidated tests provided by
unaccredited laboratories. However, these tests cannot be regarded as “medical tests” or
“pathology tests” as they do not have the analytical validity, clinical validity or clinical utility
required of a test to be used for medical purposes.
The report argues that it is both inaccurate and potentially hazardous for an unsubstantiated
non-validated test to be regarded in the same category as tests that are substantiated and
accredited for medical testing.
“Patients should talk to their GPs and specialists before seeking out any tests that may come
from non-accredited laboratories, over the counter, or over the internet, to make sure those
tests are providing useful information. Often the patient will be out of pocket and none the
wiser. Worse still, they may be misled and act on invalid test results,” says Khong.
Professor Khong explains that specific tests, such as those surrounding genetics, that are not
yet Medicare-funded, can be valuable for those who may carry inherited genetic disorders,
however, if regulations for these tests are not implemented, there is potential for misuse .
“Genetic testing is a rapidly evolving area. Many of the tests undertaken by accredited
laboratories may be clinically valuable, for example, the BRCA 1 and BRCA 2 genes that have
been linked to breast cancer. There are, however, many genetic tests that have not yet been
assessed for Medicare funding.
“Health practitioners need to be aware of the test characteristics to ensure the patient’s
concerns are met, and that the tests being performed are justifiable, avoiding unnecessary
patient anxiety,” says Khong.
The full FSM report can be viewed on the FSM website at:
www.scienceinmedicine.org.au
For further information on accredited laboratory testing, visit the RCPA website at:
www.rcpa.edu.au
ENDS
About the Royal College of Pathologists of Australasia:
The RCPA is the leading organisation representing pathologists in Australasia. Its mission is to
train and support pathologists and to improve the use of pathology testing to achieve better
healthcare. For more information please visit: http://www.rcpa.edu.au/Publications
Media enquiries:
Dr Debra Graves,
CEO – RCPA
02 8356 5813
bronwenr@rcpa.edu.au
or
Georgy Searles
S2i Communications
02 9231 2927
georgy@s2i.com.au