Maybe you are right.
But first, CALY has to stop the cash bleeding.
I ask myself why the big co's didn't catch it up years earlier when it was technically and economically viable.
For a qualification of the (formerly by defunct Cambridge Biotech) owned Urine WesternBlot test see:
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On August 6, 1996, the Company received a product license and an establishment license from the Food & Drug Administration ("FDA") to manufacture and sell, in interstate and foreign commerce, the Company's urine- based HIV-1 screening test for use in professional laboratory settings. The Company's screening test, when used with the western blot confirmatory test for urine licensed exclusively from Cambridge Biotech Corporation ("Cambridge Biotech"), will provide the only complete urine-based HIV testing system. This western blot test is already licensed by the FDA for use with blood, and is currently pending FDA clearance for use with urine. On June 21, 1996, the FDA Blood Products Advisory Committee ("BPAC") determined that the clinical data and test protocol of the Cambridge Biotech urine western blot confirmatory test supported its use to determine a positive HIV-1 test result. Based on the data presented, the BPAC recommended that the Cambridge Biotech urine western blot confirmatory test not be considered a stand-alone supplemental test and that positive reported results in urine be subsequently verified by using a blood sample.
Later on, however it has been approved, see:
fda.gov
fda.gov
and the paragraph has been rewritten to:
[In August 1996, the Company received a product license and an establishment license from the Food & Drug Administration ("FDA") to manufacture and sell, in interstate and foreign commerce, the Company's urine-based HIV-1 screening test for use in professional laboratory settings. In May 1998, Cambridge Biotech Corporation ("Cambridge Biotech") also received such licenses from the FDA with respect to the urine HIV-1 Western Blot test that confirms the presence of antibodies to HIV-1 in urine samples. This test is used on samples that are repeatedly reactive in Calypte's HIV-1 urine antibody screening test. Calypte's screening test, when used with the Western Blot supplemental test for urine, provides the only complete FDA-approved urine-based HIV testing method.] In December 1998, Calypte acquired from Cambridge Biotech certain assets relating to Cambridge Biotech's Western Blot product line for certain infectious diseases. The acquisition included the urine-based and serum-based HIV-1 Western Blot products, as well as a supplemental test for Lyme Disease and Human T-Lymphotropic Virus (HTLV).
In November 1999, Calypte received FDA approval of a "Day Assay" format for its "Cambridge Biotech" HIV-1 Western Blot assay. The FDA approval now permits use of this supplemental test in either a "Day Assay" (five hour) or overnight format, and will provide more rapid test results for customers and their patients who need the results of their HIV tests as rapidly as possible.
The tests have not been approved for detection of HIV-2. |
