Memorandum by YORKTEST Laboratories Ltd
ABOUT YORKTEST
15 MARCH 2007
YORKTEST Laboratories Ltd is a specialist provider
of food allergy and food intolerance testing, direct to the general
public, and has helped thousands of people find relief from chronic
health conditions during the past eight years. It uses a food-specific
IgG food intolerance test to identify food intolerances which
could be the cause of an individual's ill health symptoms. This
particular method was subject to scientific scrutiny in a recent
clinical trial which was published in Gut Journal. A clinical
research study is also due to be published shortly in the International
Journal of Nutrition and Food Science.
YORKTEST has worked hard to scientifically validate
its testing services and has a number of ongoing collaborations
with patient groups (Allergy UK, Action Against Allergy, IBS Network,
Migraine Association) and clinicians in order to further explore
the area of food intolerance. There is no doubt that the mechanisms
involved with food intolerance are not totally understood. However,
there is very clear evidence which supports the fact that food
intolerance can cause negative health symptoms and relief can
be found from these symptoms once the offending foods are removed
from the diet.
The area of food intolerance, as with many areas
deemed "complementary" health, suffers with a negative
image. Many providers of such services, some even readily available
on the high street, do not use scientifically validated or clinically
proven tests and are therefore unlikely to offer their customers
any relief from negative health symptoms nor do they provide any
health benefit.
YORKTEST is keen to differentiate itself from
the non-scientifically validated service providers.
YORKTEST holds three SMART awards from the DTI,
both ISO9001:2000 and ISO13485:2003 Quality Management Certificates,
and the Food Allergy and Food Intolerance Testing Services they
offer are fully compliant with the European In Vitro Diagnostic
Directive 98/79/EC Annex III, Section 6 (self-test) which includes
the Design Examination by the Notified Body (UL International).
YORKTEST also holds the Queen's Award for Enterprise: Innovation.
Despite these accreditations YORKTEST often finds itself grouped
with the less reputable organisations and still finds resistance
from GPs or clinicians whose patients are interested in exploring
YORKTEST further. YORKTEST understands this attitude as there
are many examples of non-reputable providers. However, the lack
of regulation (or the lack of policing of the existing regulations)
could actively be preventing people from finding relief from their
ill health symptoms because of the lack of differentiation within
the industry.
Q: What impact do allergies have on the quality
of life of those experiencing allergic disease and their disease?
Food intolerance, as with all types of allergy
can have a negative impact on an individual's quality of life.
Many people who turn to YORKTEST have suffered with chronic conditions
for many years and have found very little relief.
Chronic conditions can result in time off of
work, numerous visits to the GP, and costly prescription medicines
or OTC medications. From a personal perspective many people find
that chronic conditions can negatively affect their social lives
or ability to participate in sports or other activities.
The all encompassing nature of many chronic
conditions means that people often turn to private services in
an attempt to relieve their symptoms which seem unaffected by
traditional methods and treatments. People simply become desperate
and are keen to try anything which offers hope. However, it is
important that this "hope" is regulated in order for
people to identify whether it is false or has some scientific
basis.
Q: Are current regulatory arrangements, for
example those governing private clinics offering diagnostic and
therapeutic services and the sale of over the counter allergy
tests satisfactory?
— The MHRA, an agency of the Department
of Health, is responsible for regulating the safety, quality and
performance of self-test kits. The transposition of the European
IVD Directive 98/79/EC (IVDD) and European Medical Device Directive
93/42/EEC (MDD) into UK law was enacted by a statutory instrument
which in turn updates the 1987 Consumer Protection Act—and
as such is criminal legislation. Food Allergy and Food Intolerance
tests and testing services clearly provide information regarding
pathological/physiological conditions and thereby are included
in the IVDD definition of in-vitro diagnostics.
— During 2004 the MHRA and the Notified
Bodies jointly decided that, not only IVD products, but also IVD
testing services, supplied direct to end users (consumers) without
the involvement of a healthcare professional are designated as
"self-test" thereby requiring Notified Body (eg LRQA,
UL, SGS) audit of the technical files, and approval prior to registration
and placing on the market.
— Direct to consumer "self-test"
testing services have had to be in compliance with the IVDD, including
successful Notified Body audit and approval, since 7 December
2005.
Despite these laws and regulations being in
place to (supposedly) protect the consumer, there are many providers
of such services who do not use scientifically validated or clinically
proven tests and are therefore unlikely to offer their customers
any relief from negative health symptoms nor do they provide any
health benefit.
YORKTEST would welcome more regulation in this
area and believes that it is a vital step in the provision of
allergy services. In addition to the commercial implications YORKTEST
believes quite strongly that the consumer requires protection
in this area. It has been identified by the Government that allergy
is an unmet need in the UK. The Government is struggling to cope
with patients suffering from classical allergy symptoms; food
intolerance isn't even on the radar. Many people frustrated by
their symptoms seek help from sources such as private testing
services. These individuals are often desperate to find relief
having suffered for many years with chronic conditions. The lack
of regulation combined with a lay person's inability to differentiate
between these services means that the consumer often pays large
sums of money to organisations which are in no way scientifically
validated.
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