Clinical Laboratory News - American Association for Clinical ...

paragondx Gets clearance for
ambc’s rapid ToX cup cleared
Warfarin sensitivity Genotyping Kit
p
american Bio Medica announced FDA
aragonDx announced FDA clearance clearance of its Rapid TOX Cup drug
for its rapid genotyping assay that de- screen system, an all-inclusive DOA cup
tects the presence of variations in the genes platform. Available with multiple assay
CYP2C9 and VKORC1, information physi- combinations according to customer recians
can use to identify patients who are at quirements, the Rapid TOX Cup does not
greater risk for warfarin sensitivity. The test require any manipulation of the device and
can be completed within 1-hour and was includes a temperature strip affixed to the
FDA cleared using the Cepheid SmartCy- cup to ensure specimen integrity. Results
cler Dx platform.
fda clears invitrogen Transplant
can be photocopied for recordkeeping, and
the all-in-one design allows collection, testing,
and shipment for confirmation.
compatibility Test system
invitrogen announced FDA clearance for fda drops backup Testing
its DynaChip Antibody Analysis System, requirement for prodesse’s proflu+
p
the only automated chip-based system for rodesse announced that the FDA
HLA antibody detection and identification. okayed changing the package insert for
Providing fully integrated instrumentation, the ProFlu+ molecular respiratory viruses
reagents, and software, the system is com- test to remove the recommendation that
posed of a processor for automated assay negative results for flu A and B be confirmed
processing, a protein array that allows test- by culture. The agency first cleared the test
ing of multiple antibodies at the same time, in January. So far this is the only molecu-
and interpretation software for automated lar test for respiratory viruses for which the
analysis.
FDA has decided that no backup testing is
news from the fda
needed. The FDA also allowed Prodesse to
add the bioMérieux NucliSENS easyMAG
automated nucleic acid extraction system
as an acceptable extraction method for the
ProFlu+ test.
fda clears access Toxo igG assay
beckman Coulter announced the clearance
of its Access Toxo IgG assay, a
paramagnetic-particle, chemiluminescent
immunoassay for the quantitative and
qualitative determination of IgG antibodies
to Toxoplasma gondii in human serum
using the company’s Access immunoassay
instruments. The test is cleared as an aid in
the diagnosis of Toxoplasma gondii infection
and may be used to assess the immune
status of pregnant women. It’s not cleared
for screening blood or plasma donors in
the U.S.
indeX To adverTisers
please thank these advertisers by telling them you saw their
advertisement in Clinical Laboratory News.
alfa wassermann . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
bio-rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 & 25, 33
College of american pathologists . . . . . . . . . . . . . . . . . . . . . . . 13
data unlimited int’l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
diazyme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
drg international . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
fenin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
fluid Metering (oeM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
gKr industries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Hoover precision prods (oeM) . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Kamiya . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 45, 47
Kronus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Medicon Hellas sa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Midland bioproducts (oeM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
olympus america .....................................8 & 9
ortho-Clinical diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
QbC diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
roche diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 21
scantibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
siemens Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
spectraCell laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
sysmex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
tekra . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
wako ................................................... 12
wheaton science pkg (oeM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Territory manager
full Time regular
responsibilities
implement programs for achieving forecasted objectives with a specific list
of customers; develop and maintain customer/company relationships; and
provide in-service education functions for a specific list of customers. develop
and manage business relationships with targeted physicians and clinics;
maintain responsibility for territory management, analysis, development, and
growth. direct and implement sales support strategy, marketing operations,
and organizational structure, including sales and marketing analytics, field administration,
program administration, contract administration, and customer
service. Maintain responsibility for business development and management
of medical sales territory. utilize experience in nutrition and health product
sales with in-depth knowledge of human cellular function.
requirements
the position requires a bachelor’s degree in any field plus two (2) years of experience
in job offered or two (2) years of experience in nutrition and health
product sales with in-depth knowledge of human cellular function. employer
will accept any suitable combination of education, training or experience. significant
travel required.
send resumes to Joi robertson, spectraCell laboratories, inc., 10401 town park
drive, Houston, tX 77072. 713-621-3101.
CliniCal laboratory news JuLy 2008 47