Calypte Biomedical Corp (fka CBMC)

[pmunch]

CBMC DD ... I found this FDA Pre-Approval from 2001


FDA Letter : http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091391.pdf

Currently Approved CBER Device Premarket Applications (PMAs)
As of January 06, 2014

http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM149971.pdf

http://investing.businessweek.com/research/stocks/ownership/ownership.asp?ticker=CBMC


BP000009-0 Maxim Biomedical Inc
1440 Fourth Street
Berkeley, CA 94710
Trade Name: Calypte HIV-1 Urine EIA
Approved Date: 12-JAN-2001

Approved Under Calypte Biomedical Corporation

BP010009-0 Maxim Biomedical Inc
1265 Harbor Bay Parkway
Alameda, CA 94502
Trade Name: Cambridge Biotech HIV-1 Urine Western Blot
Approved Date: 21-JUN-2001
Approved Under Calypte Biomedical Corporation

http://globenewswire.com/news-release/2013/04/25/541721/10029752/en/Calypte-Biomedical-and-Maxim-Biomedical-Announce-Joint-Distribution-of-Incidence-Testing-Assays.html

alypte Biomedical and Maxim Biomedical Announce Joint Distribution of Incidence Testing Assays

April 25, 2013 12:00 | Source: Calypte Biomedical Corporation


PORTLAND, Ore., April 25, 2013 (GLOBE NEWSWIRE) -- Calypte Biomedical Corporation (OTCBB:CBMC) and Maxim Biomedical Inc. today announced a reciprocal distribution agreement under which customers may purchase from either company, on the same terms, both Calypte's Aware™ BED EIA HIV-1 Incidence Test and Maxim's HIV-1 Limiting Antigen (LAg)-Avidity EIA Kit.

The two assays are produced by their respective manufacturers under license from the Centers for Disease Control (Atlanta, GA), and use different biomarkers to classify HIV-positive blood, serum or plasma specimens as either recent or long-term infections. This information can be used to derive a measure of the number of new HIV infections in a given population (that is, "HIV incidence").

"Traditional measures of incidence, such as cohort studies, are expensive and time consuming. Cross-sectional assays such as the BED and LAg offer public health authorities faster, more cost effective access to information that is critical for monitoring the epidemic, allocating resources and evaluating intervention programmes," said Adel Karas, Chairman and CEO of Calypte.

The LAg assay is a newer methodology which is still being validated, whereas the BED assay has the advantage of more than half a decade's worth of predicate data. The partners anticipate that many laboratories which are familiar with BED will want to make their own side-by-side comparisons. In addition, recent research has indicated that algorithms which use both BED and LAg in series can provide significant improvements in specificity.

About Calypte Biomedical Corporation:

Calypte Biomedical Corporation develops in vitro testing products to improve the diagnosis of Human Immunodeficiency Virus (HIV) infection and other sexually transmitted and chronic diseases. Calypte's product line includes both point-of-care rapid tests and the BED incidence test. Founded in 1988, Calypte is a pioneer in non-blood-based HIV antibody testing.

About Maxim Biomedical, Inc.:

Maxim Biomedical, Inc. (Maxim), located in Rockville, Maryland, was founded in May 2005. Maxim's mission is to develop and market in vitro diagnostic testing solutions that make positive contributions to public health and healthcare worldwide. Maxim's product lines include urine-based tests which are designed to be safe, cost-effective, and painless, as well as blood-based tests which offer proven solutions in a traditional format. Maxim's CMO/CRO services are supported by FDA cGMP and ISO 13485 certified facility and quality management system with technical expertise covering enzyme immunoassay, Western Blot, Recombinant ImmunoBlot Assay and Molecular PCR.

Forward-Looking Statements:

This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by managements. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 related to our ability to commercialize our products, our ability to obtain sufficient financing, and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.

Media Contact: Angela Baker
Office: 503-726-2227

Maxim Biomedical Inc DD:
http://www.mbidiagnostic.com/news.html
2013-09-25 ~ 2013-09-26

Maxim Biomedical attends the FDA's Small Business Regulatory Eduation for Industry (REDI) conference in Bethesda, Maryland.


2013-08-30

Maxim Biomedical, Inc. becomes the first company in the nation to be CDC approved for HIV-1 LAg-Avidity DBS and Serum/Plasma EIA Kits.


2013-04-25

Maxim Biomedical and Calypte Biomedical announce new distribution agreement for purchase of both Maxim's HIV-1 Limiting Antigen (LAg)-Avidity EIA Kit and Calypte's Aware BED EIA HIV-1 Incidence Test.

http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/UCM080466

Cambridge Biotech HIV-1 Urine Western Blot Kit


HIV-1 WB Urine Diagnostic Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in urine specimens found to be repeatedly reactive by Maxim HIV-1 Urine EIA.


Maxim Biomedical, Inc.
Rockville, MD
US License

About Us


Maxim Biomedical, Inc. (Maxim), located in the Rockville, Maryland, was founded in May 2005. Our mission at Maxim is to develop and market in vitro diagnostic testing solutions that make positive contributions to public health and healthcare worldwide. Our urine-based tests are designed to be safe, cost-effective, and painless, while our blood-based tests offer proven solutions in a traditional format. We believe that by offering both non-blood and traditional blood-based testing solutions for HIV infection and other chronic diseases, we can create more opportunities for better healthcare worldwide.


Since its inception, Maxim has since acquired the Calypte's three product lines for screening and supplemental tests for HIV-1 antibodies. We carry reliable screening and supplemental urine tests for HIV-1 antibodies.

The HIV-1 Urine EIA [Human Immunodeficiency Virus Type 1 (Recombinant)] offers high concordance with existing blood-based tests for HIV-1 antibodies when supplemented by the Cambridge Biotech HIV-1 Western Blot Kit [Human Immunodeficiency Virus Type 1 (HIV-1)]. HIV-1 Urine EIA received an establishment license from the Food and Drug Administration on August 6, 1996, allowing the company to manufacture and sell the Calypte HIV-1 Urine EIA for use in professional laboratory settings.
On May 28, 1998, the FDA granted approval to Cambridge Biotech Corporation for a urine-based Western Blot supplementary test for HIV-1 antibodies. These two screening and confirmation products allow us to begin full commercialization of the first urine-based diagnostic algorithm for the detection of HIV-1 antibodies. Furthermore, our serum-based Cambridge Biotech HIV-1 Western Blot Kit allows laboratories to establish a definite status for samples that are positive or indeterminate by routine screening assays or newer rapid tests using serum as the substrates.


Every Maxim product is manufactured according to U.S. Food and Drug Administration (FDA) Good Manufacturing Practice standards in our 30,000 square foot facility. The company also has U.S. FDA Certificates to Foreign Governments and Certificates of Exportability for our products. Maxim markets its products through a network of national and regional distributors.