不要羊穿了.抽血即可.# NextGeneration - 我爱宝宝
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SAN DIEGO, Oct. 17, 2011 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a
life sciences company providing innovative genetic analysis solutions, today
announced that its wholly-owned subsidiary, Sequenom Center for Molecular
Medicine (Sequenom CMM), launched its noninvasive proprietary MaterniT21
laboratory developed test (LDT). The MaterniT21 LDT detects a genetic
chromosomal anomaly known as Trisomy 21, the most common cause of Down
syndrome. The test is now available to physicians upon request in 20 major
metropolitan regions across the United States.
A clinical validation study leading to the introduction of the MaterniT21
LDT has been published in the journal Genetics in Medicine. The results of
the multi-center study demonstrated high accuracy, detecting nearly all (99.
1%) positive cases of fetal Trisomy 21 with a very low false positive rate.
The full results of the multi-center study can be found online at http://journals.lww.com/geneticsinmedicine/.
"As we advance our role in developing and commercializing prenatal
diagnostics, we believe this LDT will be a welcomed addition to the testing
currently available to the prenatal and maternal care community," said Harry
F. Hixson, Jr., Ph.D., Chairman and CEO, Sequenom, Inc. "We believe that
the MaterniT21 LDT will provide physicians and their patients with critical
new information to help them make better informed decisions about the
patients' healthcare and pregnancies."
The MaterniT21 test is indicated for use in pregnant women at high-risk for
carrying a fetus with Down syndrome and can accurately test maternal blood
as early as 10 weeks of gestation. In the United States, there are an
estimated 750,000 such high-risk pregnancies each year.
"The results of this large clinical validation study are extremely promising
and the MaterniT21 LDT is accurate and will reliably identify fetuses with
Down syndrome among women with high-risk pregnancies," said Allan T. Bombard
, M.D., Laboratory Director, Sequenom CMM. "We believe perinatal specialists
and obstetricians will appreciate the introduction of a test that is
noninvasive and highly specific, meaning very low risk of a false positive
result."
To conduct the MaterniT21 test, a health provider takes a small sample of
whole blood from a pregnant woman. The sample is shipped to the Sequenom
CMM CAP accredited and CLIA-certified molecular diagnostics laboratory where
licensed laboratory personnel use proprietary sample preparation, detection
and analysis technology to measure a possible overabundance of chromosome
21 relative to the amount of other chromosomes. To learn more about the
MaterniT21 LDT, please visit Sequenomcmm.com.
Clinical Validation Study
Between April 2009 and February 2011, 27 sites enrolled women in the multi-
center validation study. The blinded, nested case control study assessed
plasma samples from women between 10 and 22 weeks gestation at high-risk for
carrying a fetus with Down syndrome (based on age, family history or a
positive serum or sonographic screening test). Samples were drawn and
processed to plasma before testing, which was conducted at Sequenom CMM over
a nine-week period (January to March 2011).
The Sequenom CMM testing methodology was evaluated for sensitivity and
specificity against a total of 212 Down syndrome samples and 1,484 matched
samples from unaffected pregnancies. In the initial round of uncorrected
blinded analysis, the test identified 209 of the 212 cases of Down syndrome
(98.6% accuracy), with three false positives (0.2%) and three false
negatives. In the corrected blinded analysis, an adjustment to certain DNA
variables was applied, a process that is consistent with the MaterniT21
commercial version of the test. With that adjustment, the test correctly
identified 210 of the 212 samples (99.1% accuracy), with just one false
positive and two false negatives.
Laboratory Developed Test Offering
The samples will be processed at the Sequenom CMM's CAP accredited and CLIA-
certified laboratory, where the MaterniT21 LDT was developed and validated.
Physicians are expected to receive testing results in about 8-10 business
days on average.
The out-of-pocket cost of the test for insured patients will be no more than
$235. Sequenom CMM will initially operate as an out-of-network provider to
ensure eligible patients will have coverage for the test. While negotiating
to ensure coverage by most major private insurance programs, the
reimbursement for the test is expected to be similar to that of current
invasive procedures like amniocentesis or CVS.
Conference Call Information
A conference call and slide presentation will be held today, October 17,
2011, at 9:30 a.m. ET and will be accessible live on the "Investor Relations
" section of the Sequenom website at http://www.sequenom.com/home/investor-relations/. An online replay will be available following the initial broadcast until October 25, 2011.
To access the call via live teleconference, dial 800-860-2442 in the U.S.,
866-605-3852 in Canada (both are toll free), and 412-858-4600 for other
international callers. Please specify to the operator that you would like
to join the "Sequenom MaterniT21 Launch Conference Call."
life sciences company providing innovative genetic analysis solutions, today
announced that its wholly-owned subsidiary, Sequenom Center for Molecular
Medicine (Sequenom CMM), launched its noninvasive proprietary MaterniT21
laboratory developed test (LDT). The MaterniT21 LDT detects a genetic
chromosomal anomaly known as Trisomy 21, the most common cause of Down
syndrome. The test is now available to physicians upon request in 20 major
metropolitan regions across the United States.
A clinical validation study leading to the introduction of the MaterniT21
LDT has been published in the journal Genetics in Medicine. The results of
the multi-center study demonstrated high accuracy, detecting nearly all (99.
1%) positive cases of fetal Trisomy 21 with a very low false positive rate.
The full results of the multi-center study can be found online at http://journals.lww.com/geneticsinmedicine/.
"As we advance our role in developing and commercializing prenatal
diagnostics, we believe this LDT will be a welcomed addition to the testing
currently available to the prenatal and maternal care community," said Harry
F. Hixson, Jr., Ph.D., Chairman and CEO, Sequenom, Inc. "We believe that
the MaterniT21 LDT will provide physicians and their patients with critical
new information to help them make better informed decisions about the
patients' healthcare and pregnancies."
The MaterniT21 test is indicated for use in pregnant women at high-risk for
carrying a fetus with Down syndrome and can accurately test maternal blood
as early as 10 weeks of gestation. In the United States, there are an
estimated 750,000 such high-risk pregnancies each year.
"The results of this large clinical validation study are extremely promising
and the MaterniT21 LDT is accurate and will reliably identify fetuses with
Down syndrome among women with high-risk pregnancies," said Allan T. Bombard
, M.D., Laboratory Director, Sequenom CMM. "We believe perinatal specialists
and obstetricians will appreciate the introduction of a test that is
noninvasive and highly specific, meaning very low risk of a false positive
result."
To conduct the MaterniT21 test, a health provider takes a small sample of
whole blood from a pregnant woman. The sample is shipped to the Sequenom
CMM CAP accredited and CLIA-certified molecular diagnostics laboratory where
licensed laboratory personnel use proprietary sample preparation, detection
and analysis technology to measure a possible overabundance of chromosome
21 relative to the amount of other chromosomes. To learn more about the
MaterniT21 LDT, please visit Sequenomcmm.com.
Clinical Validation Study
Between April 2009 and February 2011, 27 sites enrolled women in the multi-
center validation study. The blinded, nested case control study assessed
plasma samples from women between 10 and 22 weeks gestation at high-risk for
carrying a fetus with Down syndrome (based on age, family history or a
positive serum or sonographic screening test). Samples were drawn and
processed to plasma before testing, which was conducted at Sequenom CMM over
a nine-week period (January to March 2011).
The Sequenom CMM testing methodology was evaluated for sensitivity and
specificity against a total of 212 Down syndrome samples and 1,484 matched
samples from unaffected pregnancies. In the initial round of uncorrected
blinded analysis, the test identified 209 of the 212 cases of Down syndrome
(98.6% accuracy), with three false positives (0.2%) and three false
negatives. In the corrected blinded analysis, an adjustment to certain DNA
variables was applied, a process that is consistent with the MaterniT21
commercial version of the test. With that adjustment, the test correctly
identified 210 of the 212 samples (99.1% accuracy), with just one false
positive and two false negatives.
Laboratory Developed Test Offering
The samples will be processed at the Sequenom CMM's CAP accredited and CLIA-
certified laboratory, where the MaterniT21 LDT was developed and validated.
Physicians are expected to receive testing results in about 8-10 business
days on average.
The out-of-pocket cost of the test for insured patients will be no more than
$235. Sequenom CMM will initially operate as an out-of-network provider to
ensure eligible patients will have coverage for the test. While negotiating
to ensure coverage by most major private insurance programs, the
reimbursement for the test is expected to be similar to that of current
invasive procedures like amniocentesis or CVS.
Conference Call Information
A conference call and slide presentation will be held today, October 17,
2011, at 9:30 a.m. ET and will be accessible live on the "Investor Relations
" section of the Sequenom website at http://www.sequenom.com/home/investor-relations/. An online replay will be available following the initial broadcast until October 25, 2011.
To access the call via live teleconference, dial 800-860-2442 in the U.S.,
866-605-3852 in Canada (both are toll free), and 412-858-4600 for other
international callers. Please specify to the operator that you would like
to join the "Sequenom MaterniT21 Launch Conference Call."