Originally Published IVD Technology
November/December 2004
INDUSTRY NEWS
NotablesMolecular screening increases the safety of the U.S. blood supply, according
to a recent study funded by the National Heart, Lung, and Blood Institute
(Bethesda, MD). The study showed that nucleic acid amplification testing
detects HIV-1- and HCV-infected blood in cases missed by standard screening
tests for antibodies and antigens. Nucleic acid amplification testing also allows
for earlier detection of the viruses in blood, as it often takes time for viral
antibodies or antigens to appear in blood from recently infected donors.
Although nucleic acid testing offers advantages over traditional tests, incentives
to invest in and adopt these tests are eroding, says AdvaMed (Washington,
DC). The association points to the reimbursement procedures of the Centers
for Medicare and Medicaid Services (CMS; Baltimore) as the principal holdup
in the adoption of such cutting-edge tests. The association cites flaws in CMS
billing, coding, and payment systems as the main roadblocks to proper reimbursement.
AdvaMed calls to IVD manufacturers for help. IVD companies can improve the prospects
for the viability of the market for their molecular tests by taking part in
the association’s activities. “If a company wants to have a seat at
the policy-development table, keep abreast of important reimbursement information,
and learn from the experiences of its competitors, then participation in AdvaMed’s
diagnostics sector and associated working groups is the best, if not the only,
way to do those things,” says an association spokesperson.
A new guidance released by the Medicines and Healthcare Products Regulatory
Agency (MHRA; London) states that home-brew IVDs remain exempt from the
requirements of the IVD Directive when patient samples are sent by a different
legal entity to a health institution for testing. The guidance amends a letter
sent by the agency to the National Health Service Trusts and Strategic Health
Authorities (London) last year that put IVDs that are developed in-house under
the jurisdiction of the IVD Directive.
According to Article 1.5 of the directive, IVDs are exempt from the requirements
of the directive if they are “devices manufactured and used only within
the same health institution and on the premises of their manufacture or used
on premises in the immediate vicinity without having been transferred to another
legal entity.”
MHRA adds that if a test meets these conditions for exemption, “it is irrelevant
that a diagnostic service is being provided to a different legal entity—the
exemption will still apply.”
MHRA does not consider freestanding laboratories to be health institutions,
and therefore such labs do not qualify for the exemption. However, freestanding
laboratories may benefit from this exemption, as they may be able to send samples
to exempted health institutions to be tested with home-brew IVDs.
As a prerequisite for publication of results in many major medical journals
around the globe, IVD manufacturers will need to register their clinical trials
in a public registry at the inception of the trials. The International Committee
of Medical Journal Editors (ICMJE), which counts editors of the New England
Journal of Medicine, the Journal of the American Medical Association, and The
Lancet among its members, now requires registration to guarantee that both unfavorable
and favorable results are reported and are accessible to the public.
In an editorial published in all ICMJE-member journals in September, the committee
states that there is a need for such registration because selective reporting
occurs in clinical trials and “distorts the body of evidence available
for clinical decision making.” The committee also notes that “registration
is only part of a means to an end; that end is full transparency with respect
to performance and reporting of clinical trials.”
The committee presents a list of criteria that must be met by a registry for
ICMJE to consider it a qualifying registry. The authors state that the U.S.
National Laboratory of Medicine’s (NLM) registry meets these criteria.
The NLM registry can be found on-line at www.clinicaltrials.gov.
IVD manufacturers may soon need to adjust their glycated hemoglobin (A1c) tests
to an internationally recognized standard. The International Federation of
Clinical Chemistry and Laboratory Medicine (Milan, Italy) working group
has been working to find analytes to establish a reference method to measure
A1c. Such a standard may be available as early as January 2005.
Both laboratorians and manufacturers have been working to standardize measurements
to gain comparable metabolic control from a variety of studies in different
countries. However, countries with strong IVD markets, including the United
States, Australia, Japan, and Canada, all use varying benchmarks for the test.
Once a standard is available for the marker, diagnostic levels for measuring
range, precision interferences, and stability may need to be adjusted. Such
alterations will be implemented at a steep cost in terms of both the time and
the cost necessary to provide sufficient education to end-users.
Frequented by users from around the globe, Lab Tests Online will likely receive
more than 4 million visitors within this calendar year. The Web site was developed
by the American Association for Clinical Chemistry (AACC; Washington,
DC) to provide industry-sponsored information for patients and caregivers about
clinical lab tests. With roughly 13,000 visitors per day, the site is reaching
a large audience.
About the usefulness of the site, one anonymous user writes, “I am an International
Red Cross delegate currently working for a medical project for Iraq. Your site
has been incredibly useful to me for many different reasons . . . and hopefully
for the patients.”
A sister site, Lab Tests Online–UK, has experienced similar popularity.
The site was launched in June and received 22,000 visitors within two months.
The UK site is published by the Association of Clinical Biochemists (London)
under a license agreement with AACC.
Copyright ©2004 IVD Technology
