- Lung cancer is the leading cause of
cancer-related deaths in the United States
- Early detection with low dose CT can
improve prognosis and treatment and reduce mortality rates for
patients with a high risk of lung cancer
GE Healthcare is proud to be the first company with a low dose
computed tomography (CT) lung cancer screening optioni that is
cleared by the U.S. FDA for lung cancer screening.ii Both the U.S.
Preventative Services Task Force (USPSTF) and the Centers for
Medicare and Medicaid Services (CMS) recommend the use of low dose
CT lung cancer screening for high-risk individuals.iii, iv
Additionally, Medicare has approved insurance reimbursement for its
beneficiaries who are eligible for the use of low dose CT lung
cancer screening in high-risk patients.v Early detection from an
annual lung cancer screening with low dose CT in high-risk persons
can prevent a substantial number of lung cancer–related
deaths.iv
“Bringing low dose CT screening to patients at a high risk for
lung cancer will reduce death from the most deadly cancer
worldwide,” said Dr. Ella Kazerooni, chair of committee on lung
cancer screening, American College of Radiology. “Performing low
dose CT with attention to high image quality at the lowest
radiation exposure to detect early cancer is at the core of a
successful screening program, and requires collaboration with
imaging partners to bring technology to bear for this purpose. The
FDA’s clearance of these CT scanners for this purpose illustrates
that commitment.”
Physicians using low dose CT for lung cancer screening will now
have access to the benefits from a screening indication, including
GE Healthcare’s new low-dose screening reference protocols. These
new protocols are tailored to the CT system, patient size, and the
most current recommendations from a wide range of professional
medical and governmental organizations. Now, qualified GE
Healthcare CT scanners can be confidently used by physicians within
their FDA cleared indications for use, delivering low dose, short
scan times, and clear and sharp images for the detection of small
lung nodules. These nodules are critical in identifying lung cancer
at its earliest stages when it is the most treatable and
curable.vi
The landmark National Lung Screening Trial (NLST) was conducted
at 33 medical institutions with over 53,000 older, otherwise
healthy patients at high-risk due to smoking history. Half of the
participants were screened using low dose CT, the other half were
screened using chest X-ray. The trial demonstrated that the use of
low dose CT screening decisively reduced the mortality rate from
lung cancer by 20 percent compared to use of chest X-ray. The NLST
also revealed a significant 6.7 percent reduction in the rate of
death from any cause using low dose CT screening.vii
All new 64-slice and greater CT scanners, and virtually all of
the 16-slice CT scanners that GE Healthcare sells are qualified
systems and will include the screening option. The solution that GE
Healthcare developed is also available to thousands of qualified GE
scanners currently in use, increasing access to the quality
scanners that satisfy both patient and physician needs. The new
protocols are able to utilize GE Healthcare’s industry-leading
technologies such as ASiRTM, ASiR-VTM and VeoTM that are designed
to reduce image noise, which is undesirable for physicians looking
for small nodules.
In the United States, lung cancer is the third most common
cancer and the leading cause of cancer deaths; it kills almost
twice as many women as breast cancer and three times as many men as
prostate cancer. Survival rates from lung cancer are highly
correlated to its initial stage at the time of first diagnosis. The
overall five year survival rate for lung cancer is among the lowest
(17 percent) of all types of cancer but is significantly higher
when the cancer is diagnosed at an early stage (54 percent).
However, currently only 15 percent of lung cancer cases are
diagnosed at such an early stage.viii, ix The use of low dose CT
lung cancer screening increases this percentage of early stage
detection, providing patients a much better prognosis.
“This is the first time in history that any CT device has
received FDA clearance for any screening indication,” said Henry
Hummel, president and CEO of Molecular Imaging and CT at GE
Healthcare. “GE Healthcare is thrilled to be the first CT vendor
who can help clinicians establish low dose CT lung screening
programs in order to continue improving the health of their
patients. Healthcare providers are looking for solutions beyond
just imaging equipment; we look forward to helping them establish
low dose CT lung cancer screening programs that will inevitably
save lives through earlier diagnosis and treatment for
patients.”
About GE Healthcare
GE Healthcare provides transformational medical technologies and
services to meet the demand for increased access, enhanced quality
and more affordable healthcare around the world. GE (NYSE: GE)
works on things that matter - great people and technologies taking
on tough challenges. From medical imaging, software & IT,
patient monitoring and diagnostics to drug discovery,
biopharmaceutical manufacturing technologies and performance
improvement solutions, GE Healthcare helps medical professionals
deliver great healthcare to their patients.
For our latest news, please visit
http://newsroom.gehealthcare.com.
i The FDA has cleared the following qualified GE Healthcare CT
scanners to receive the new low dose CT Lung Cancer Screening
Option: LightSpeed 16, BrightSpeed Elite, LightSpeed Pro16, Optima
CT540, Discovery CT590 RT, Optima CT580, Optima CT580 W, Optima
CT590 RT, LightSpeed Xtra, LightSpeed RT16, LightSpeed Pro32,
LightSpeed VCT, LightSpeed VCT XT, LightSpeed VCT XTe, LightSpeed
VCT Select, Optima CT660, Revolution EVO, Discovery CT750 HD,
Revolution Discovery CT, Revolution GSI, Revolution HD, and
Revolution CT.
ii The Low Dose CT (LDCT) Lung Cancer Screening Option (LCS) for
qualified GE Systems is indicated for using low dose CT for lung
cancer screening. The screening must be performed within the
established inclusion criteria of programs/protocols that have been
approved and published by either a governmental body or
professional medical society.
iii The USPSTF recommends annual screening for lung cancer with
low-dose computed tomography (LDCT) in adults aged 55 to 80 years
who have a 30 pack-year smoking history and currently smoke or have
quit within the past 15 years.
iv Moyer V. Screening for Lung Cancer: U.S. Preventive Services
Task Force Recommendation Statement. Ann Intern Med.
2014;160:330-338.
http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/lung-cancer-screening
v CMS has determined that those beneficiaries who are 55-77,
asymptomatic, have a tobacco smoking history of at least 30
pack-years, are a current smoker or one who has quit smoking within
the last 15 years; and receives a written order for LDCT lung
cancer screening may receive an annual screening for lung cancer
with low dose computed tomography (LDCT), as an additional
preventive service benefit under the Medicare program. - CMS:
Decision Memo for Screening for Lung Cancer with low dose Computed
Tomography (LDCT) (CAG-00439N)
vi The International Early Lung Cancer Action Program
Investigators. Survival of Patients with Stage I Lung Cancer
Detected on CT Screening. N Engl J Med 2006;355:1763-71.
vii The National Lung Screening Trial Research Team. Reduced
Lung-Cancer Mortality with low dose Computed Tomographic Screening.
N Engl J Med 2011;365:395-409.
http://www.nejm.org/doi/full/10.1056/NEJMoa1102873
viii American Cancer Society. Cancer Facts and Figures 2015.
ix National Cancer Institute. Surveillance, Epidemiology, and
End Results Program (SEER). SEER Stat Fact Sheets: Lung and
Bronchus Cancer.
http://seer.cancer.gov/statfacts/html/lungb.html
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Media Contact:GE HealthcareAmanda
GintoftAmanda.gintoft@ge.com414-412-7062
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