HER2 Support Group Forums - View Single Post - ~Rich66~Update on Mom If You have A Moment

Lani · 09-17-2008, 06:05 PM

(perhaps even two)
]an article about New breast-cancer tests perhaps being too costly cited
TWO new diagnostic tests which could further hospitals' reach into the world of
genetic testing--it's unclear whether the new technologies for
detecting a breast-cancer gene will be better options financially than
existing tests or improve clinical outcomes.

Existing tests for her 2 to determine if a patient is a candidate for herceptin
" are thought to be sometimes unreliable and can be expensive. By contrast,
manufacturers of the newer HER2 tests--Invitrogen Corp.'s SpotLight
HER2 Chromogenic In Situ Hybridization, or CISH, test and Monogram
Biosciences' HERmark test--say their versions are either a better predictor
of Herceptin-treatment candidates or more affordable and equally as
accurate. The new offerings are competing to siphon market share from
Abbott Molecular's existing Fluorescence In Situ Hybridization, or FISH,
technology--currently considered the gold standard for HER2-gene
testing--and the Denmark-based diagnostics company Dako's HercepTest-
-currently used as a front-line test for the HER2 gene.
Despite some promising claims regarding the tests, hospitals are likely to
take a go-slow approach toward adopting them.
The maker of the Spot-Light CISH test is targeting current users of
Abbott's FISH test. Marketed under the name PathVysion, FISH probes
breast tumors for HER2 DNA then uses a florescent microscope to check
the sample for overproduction of HER2 genes. The test is considered the
more accurate of the two established diagnostic technologies, but FISH
testing does present challenges to providers. "It requires more time, is
more expensive and requires a special florescent microscope" when
compared to the older HercepTest, said Brian Leyland-Jones, director of
the Emory Winship Cancer Institute.
CISH operates without the need for a fluorescent microscope. As a result,
providers are anxious to see whether CISH could be a clinically sound,
more affordable substitute for FISH, Leyland-Jones added, noting
research suggests it might. According to a multicenter study conducted
by researchers at the 512-bed University of Texas M.D. Anderson Cancer
Center ill Houston, the University of Tampere in Finland and Invitrogen's
pathology department in Camarillo, Calif., FISH and CISH achieved nearly
identical results in identifying candidates for Herceptin treatment. For the
study, pathologists ran comparison tests on 226 breast-cancer specimens,
and found a 99% rate of agreement.
According to Bill Sweet, Invitrogen's director of product management, the
CISH costs about $70 per kit compared with $145 per kit for FISH,
adding that hospitals can bill for CISH under existing FISH CPT codes.
Medicare currently reimburses at a rate of $169 for FISH testing.
Meanwhile, at $3,350 per test, the new HERmark test is significantly
more expensive than any of its competitors. Monogram is wagering,
however, that the accuracy of HERmark will make it an appealing option.
Like HercepTest, HERmark looks for HER2 proteins. But HERmark is able
to take a precise measure of the level of the protein where HercepTest
relies on a pathologist's view of a specimen to estimate the level.
"The thought is, HERmark may be more accurate (than the three other
tests) in determining whether a patient will benefit from treatment with
Herceptin because Herceptin targets the HER2 protein and not the gene,"
explained Edith Perez, chairwoman of the Mayo Clinic's breast cancer
program. Mayo provided Monogram Bioscience with tumor specimens to
be used in additional studies of the diagnostic test, but Perez said that
she has received no compensation for participating in the research work.
Monogram Bioscience Chief Financial Officer Alfred Merriweather said that
reimbursement shouldn't be an issue for providers, as HERmark is a
proprietary diagnostic test. As a result, Invitrogen, not hospitals or
patients, will incur the responsibility for seeking reimbursement from
payers. Still, at $3,350 per test, HERmark's cost far outpaces insurers'
current rates of reimbursement for HER2 testing. "

09-17-2008, 06:05 PM	#16
Lani Senior Member Join Date: Mar 2006 Posts: 4,778	there is a new test approved to recheck equivocal FISH results (perhaps even two) ]an article about New breast-cancer tests perhaps being too costly cited TWO new diagnostic tests which could further hospitals' reach into the world of genetic testing--it's unclear whether the new technologies for detecting a breast-cancer gene will be better options financially than existing tests or improve clinical outcomes. Existing tests for her 2 to determine if a patient is a candidate for herceptin " are thought to be sometimes unreliable and can be expensive. By contrast, manufacturers of the newer HER2 tests--Invitrogen Corp.'s SpotLight HER2 Chromogenic In Situ Hybridization, or CISH, test and Monogram Biosciences' HERmark test--say their versions are either a better predictor of Herceptin-treatment candidates or more affordable and equally as accurate. The new offerings are competing to siphon market share from Abbott Molecular's existing Fluorescence In Situ Hybridization, or FISH, technology--currently considered the gold standard for HER2-gene testing--and the Denmark-based diagnostics company Dako's HercepTest- -currently used as a front-line test for the HER2 gene. Despite some promising claims regarding the tests, hospitals are likely to take a go-slow approach toward adopting them. The maker of the Spot-Light CISH test is targeting current users of Abbott's FISH test. Marketed under the name PathVysion, FISH probes breast tumors for HER2 DNA then uses a florescent microscope to check the sample for overproduction of HER2 genes. The test is considered the more accurate of the two established diagnostic technologies, but FISH testing does present challenges to providers. "It requires more time, is more expensive and requires a special florescent microscope" when compared to the older HercepTest, said Brian Leyland-Jones, director of the Emory Winship Cancer Institute. CISH operates without the need for a fluorescent microscope. As a result, providers are anxious to see whether CISH could be a clinically sound, more affordable substitute for FISH, Leyland-Jones added, noting research suggests it might. According to a multicenter study conducted by researchers at the 512-bed University of Texas M.D. Anderson Cancer Center ill Houston, the University of Tampere in Finland and Invitrogen's pathology department in Camarillo, Calif., FISH and CISH achieved nearly identical results in identifying candidates for Herceptin treatment. For the study, pathologists ran comparison tests on 226 breast-cancer specimens, and found a 99% rate of agreement. According to Bill Sweet, Invitrogen's director of product management, the CISH costs about $70 per kit compared with $145 per kit for FISH, adding that hospitals can bill for CISH under existing FISH CPT codes. Medicare currently reimburses at a rate of $169 for FISH testing. Meanwhile, at $3,350 per test, the new HERmark test is significantly more expensive than any of its competitors. Monogram is wagering, however, that the accuracy of HERmark will make it an appealing option. Like HercepTest, HERmark looks for HER2 proteins. But HERmark is able to take a precise measure of the level of the protein where HercepTest relies on a pathologist's view of a specimen to estimate the level. "The thought is, HERmark may be more accurate (than the three other tests) in determining whether a patient will benefit from treatment with Herceptin because Herceptin targets the HER2 protein and not the gene," explained Edith Perez, chairwoman of the Mayo Clinic's breast cancer program. Mayo provided Monogram Bioscience with tumor specimens to be used in additional studies of the diagnostic test, but Perez said that she has received no compensation for participating in the research work. Monogram Bioscience Chief Financial Officer Alfred Merriweather said that reimbursement shouldn't be an issue for providers, as HERmark is a proprietary diagnostic test. As a result, Invitrogen, not hospitals or patients, will incur the responsibility for seeking reimbursement from payers. Still, at $3,350 per test, HERmark's cost far outpaces insurers' current rates of reimbursement for HER2 testing. "