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AT RISK OR CONCERNED ABOUT PROSTATE
CANCER?
Dateline...Washington D.C....
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BioSafe®
PSA4
Prostate Cancer Screening
Test
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A confidential, quantitative
diagnostic test performed at home for determining elevated Prostate Specific Antigen (PSA) levels.
High blood serum PSA readings have been confirmed and validated as a significant
marker for abnormal prostate function including malignant cancerous tumors. A
PSA level blood screen plus a digital palpitation examination is recommended for
all men aged fifty and older as part of the routine physical examination.
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INTENDED
USE:
The
PSA4 (Prostate Specific Antigen) Screening test is a
quantitative screening test to identify PSA system levels in whole blood. System PSA
levels of 3 ng/ml or greater are generally accepted to be an indication that
further evaluation and consultation with a healthcare professional is warranted.
The BioSafe PSA4 Prostate Cancer Screening Test provides the same clinical
results that can be obtained from a local medical laboratory without the high
expense and inconvenience of physician appointments, laboratory fees, and often
painful and unnecessary procedure of direct venous or arterial blood draws. The
test is performed at home, takes less than 10 minutes and results are obtained
in approximately the same time as those routinely ordered through a physician.
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Sample
Test Result
Click to Enlarge |
PRINCIPLES
OF THE TEST
Prostate Specific Antigen (PSA) is secreted by the
epithelial cells of the acini and ducts in the prostate gland. Normal total PSA
concentration in whole blood is 0.1-2.6 ng/ml PSA. Laboratory
and medical research studies have determined
that elevated levels of PSA is a most useful tumor marker in the preliminary
diagnosis of prostate cancers. Normal levels are
generally agreed to range up to 3
ng/ml PSA, elevated levels up to 9 ng/ml and
levels over 9 ng/ml as extremely abnormal. High PSA
levels are not definitive in themselves as a diagnosis of prostate cancer. Other
procedures are necessary to confirm a diagnosis including ultrasound and biopsy.
Benign Prostatic Hyperplasia (BPH) or enlargement of the prostate is very common
in men over fifty and typical symptoms mimic more serious prostatic
complications thus necessitating further examination. However, as with most
cancers, early detection can greatly improve the successful treatment of the
disease and the PSA4 Screening Test can provide valuable information in that
regard.
TEST COMPONENTS PROVIDED
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FDA approved PSA
Sample Collection Kit:
Pre-treated sample card, finger lancet, gauze, alcohol swab, band-aid,
test form and instruction manual (English/Spanish)
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Prepaid laboratory mailer
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Prepaid quantitative PSA analysis by CLIA
Certified Laboratory
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Laboratory notification, certification, review and
explanation of test results
by a physician within 5 days
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Insurance reimbursement* form and procedure code (plan coverage
dependent) |
TEST
PROCEDURE
The PSA4 test is very easy to perform in the
privacy, confidentiality and convenience of the home. The Five basic steps:
The carbonless sample identification form is filled out, A blood sample is
obtained through a simple finger prick using the virtually painless, spring
loaded lancet, the sample blood is applied to special predefined areas on a
sample collection card, a copy of the completed form, the collection card are
then placed in the pre-addressed, postage paid mailer and sent to the
laboratory. PSA specific tests are performed, the results are tabulated in
report form, reviewed by a physician and returned
within five days.
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Complete
Form |
Get
Sample |
Apply
Sample |
Mail |
Get
Results |
AVAILABILITY
The BioSafe PSA4 Prostate Cancer Screening Test is FDA approved and available for home or
professional use in the following standard sales units. Each test kit is all
inclusive and individually boxed with all the components required to perform one
PSA test and laboratory analysis report. There is no additional costs beyond the
kit purchase price and all laboratory processing fees, physician review and mailing costs are
prepaid and included. Cost of the test may be reimbursable under certain
insurance plans* however purchaser must handle this separately.
Professional and reseller volume discounts apply to quantity purchases beyond
the sale units listed. Contact
Customer Service for volume
quotations.
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Description
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Packaging
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Units
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Cost
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Order
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BioSafe®
PSA4
Home Screening Test
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Boxed Kit each
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One (1)
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$45.00
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Three (3)
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$120.00
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Six (6)
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$210.00
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Twelve (12) |
$375.00 |
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*If the
order buttons are absent or inoperable, please use the
pricing overview page to order. |
* No responsibility for insurance
reimbursement is assumed and no information on specific coverage is provided

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