This company is not that far from you. They use a proprietary blood marker for a number of different ca's. Bladder ca test on market, prostate very soon or already approved. Randy and I had shares in the company. Sounds good, but they have a very weird chart. I sold to buy GENR.
Regards to you.
lois
Matritech Inc 330 Nevada Street Newton, MA 02460 Phone: (617) 928-0820 Fax: (617) 928-0821 Email: rsandberg@maritech.com Web Site: http://www.matritech.corp
Matritech, Inc. developed and manufactures and markets cancer diagnostic products based on its proprietary nuclear matrix protein technology. In all its programs, the Company intends to use the basic technologies in development programs undertaken by Matritech or its licensees to create products or services that will generate medically useful information. It has identified three principal approaches to delivering this information, two of which are types of products. Lab Test Kits are generally sold for use in appropriately licensed clinical laboratories or doctor's office laboratories to perform lab-testing services. Point-of-Care Test Devices are generally sold for use in a medical facility or physician's office by medical personnel who need not be licensed to perform laboratory tests. Proprietary Laboratory Procedures are under development using the Company's technologies for prostate and breast cancer.
[The FDA is saying that a 510(k) device clearance does not suffice and that BZET must instead submit a PMA, which is a device submission that roughly corresponds to an NDA for a drug.
At one time, BZET was one of the largest holdings in the H&Q Healthcare and H&Q Life Sciences closed-ends funds (twin funds that I used to own when they could be bought at a discount to NAV). BZET has been a disaster for these funds and today’s drubbing obviously doesn’t help.]
>> FDA Responds to Biofield's Request for Reclassification of New Breast Proliferation Rate Detection System
Wednesday March 9, 12:49 pm ET
ATLANTA, March 9 /PRNewswire-FirstCall/ -- Biofield Corp. (OTC Bulletin Board: BZET), announced today that the U.S. Food and Drug Administration (FDA) has conducted a review of the Company's request for reclassification of the Biofield Breast Proliferation Rate Detection System that is intended as an adjunct that may support other modalities such as mammography, clinical breast exam, sonography, and MRI used in breast cancer diagnosis.
The FDA determined that the Biofield device does not meet the criteria for class I (General Controls) or class II (Special Controls) classification and therefore falls into Class III, for which 510(k) clearance does not apply, but rather approval must be sought through a PreMarket Approval (PMA).
David M. Long, Jr., MD, PhD, Chairman and CEO of Biofield Corp. stated, "The Company intends to meet shortly with the FDA to discuss regulatory pathways and data requirements. The Company plans to cooperate with the FDA in this process of moving forward under the format of a PreMarket Approval (PMA)." <<
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