Horseshoe Crabs and
LAL Testing: Myths vs. Facts
To counteract the myths currently being disseminated within the
biomedical industry about the population status of the Atlantic
horseshoe crab and the use of its blood in the testing process,
we present the below facts to clear up any confusion the myths
might be causing:
Limulus polyphemus
Myth: The Atlantic horseshoe crab is a threatened species.
The earliest horseshoe crab fossils are
found in geologic layers from the late
Ordovician period, roughly 450 million
years ago. Unlike most species which
go extinct after approximately 10 million
years on average, the horseshoe crab
has changed remarkably little in the last
250 million years.
Fact: The Atlantic horseshoe crab has existed for over 400 million
years. This sustainable resource is thriving more than ever, at numbers
not seen in decades, due to modern legal protections that reserve it
for biomedical applications. According to the independent study, 2010
Review of the 2009 ASMFC Fishery Management Plan for Horseshoe
crab (Limulus polyphemus), “The stock assessment indicates
abundance has increased in the Southeast and Delaware Bay Regions.”
Myth: LAL demand outstrips supply.
Fact: Our own rapid testing technology, the FDA-licensed PTS™
cartridge, further safeguards this 440-million-year-old (and counting)
species, by using 20 times less raw material than traditional LAL
tests. If all tests were performed using the PTS™, Charles River alone
could more than meet the entire worldwide demand today, without
needing to bleed one additional crab over and above our normal yearly
requirements, and still have stock to spare for any additional increase
that may occur.
Myth: Major disasters in 2010 have had negative impacts on the
horseshoe crab population.
Fact: Disasters such as the Gulf of Mexico oil spill and the Iceland
volcano eruption have not impacted the horseshoe crab whatsoever.
Further, if some unprecedented-in-history catastrophe were to occur,
Charles River stocks years’ worth of supply. Again, this species has
lasted 400 million years through uncountable natural disasters and are
more protected now than they’ve ever been.
Horseshoe crabs look similar to
crustaceans, but actually belong to
the subphylum Chelicerata, and are
therefore more closely related to
spiders and scorpions.
Myth: Synthetic alternatives to LAL currently on the market are a more practical option
than LAL drawn from horseshoe crab blood.
Fact: The synthetic alternative to horseshoe crab blood currently on the market
is not FDA-licensed and requires time and funding to specially validate its use. In
addition, most, if not all, drug applications will have been filed based on the use of the
compendial bacterial endotoxin testing method. A revision of each and every submission
will be required for every drug tested with synthetic LAL.
Myth: Synthetic alternatives to natural LAL are more environment-conscious.
Fact: The truly “green” strategy is to use the Charles River Endosafe®-PTS™ and
Endosafe–MCS™ cartridge technology because it significantly reduces LAL per test
and eliminates the need for the costly time and paperwork involved in validating an
alternative method. In addition, without the continued need for the horseshoe crab by
the biomedical industry, the above-referenced legal protection for this special species is
not guaranteed and horseshoe crabs would again fall prey to use as bait by fisherman.
The myths are that easy to address. The horseshoe crab will long outlive our own
species and LAL testing technology is the gold standard for endotoxin testing, accepted
by regulatory authorities, and the best option for endotoxin testing, both now and in the
long run.
Contact Us
USA Tel: +1 (877) CRIVER-1 • Email: [email protected]
Europe Tel: 00 800 15 78 97 43 • Email: [email protected]
© 2011, Charles River Laboratories International, Inc.,
www.criver.com