FDA WARNS KINDERHOOK FIRM OVER DRUG TEST KIT

Agency Says American Bio Medica Changed Standards For Interpreting Test Results

WASHINGTON -- American Bio Medica Corp., a Columbia County-based maker of
human drug-testing devices, didn't notify the U.S. Food and Drug
Administration when it changed the way results are calculated in one of its
products, according to a warning letter from the agency released Tuesday.

The Aug. 26 letter, written in response to two inspections in February and
March, said the company failed to get agency approval to change the
standards by which results are interpreted in the company's 5 Panel Rapid
Drug Screen. The device is used to test for the presence of illicit drugs,
such as cocaine, marijuana and opiates, in the blood, saliva or urine.

The FDA's letter also said that the expiration date label imprinted on the
packaging of the test was unclear and that the company did not base
expiration dates on "reliable, meaningful and specific test methods."

American Bio Medica spokeswoman Melissa Decker said the company's attorney
is in discussions with FDA officials and expects the matter to be resolved
within 10 days. The federal agency's concerns involve literature inserted
in the product package rather than the product itself, she said.

"We're not concerned with it, we are dealing with it," Decker said. "To us,
it's not -- I hate to use the term big deal -- but it's not."

American Bio Medica had filed for agency approval of the drug test using a
streamlined process intended to expedite approval of products that are
similar to ones already on the market. But the FDA determined the
alteration was sufficiently different from other products to require an
additional review for effectiveness.

Shares in American Bio Medica fell 3 cents Tuesday to $1.41.

The FDA sends hundreds of warning letters to companies each year, and only
a small number result in significant agency action. Still, the letters can
be the last notice before the FDA takes steps such as seizing products or
pursuing civil fines.

Meanwhile, American Bio Medica announced Tuesday that it has completed a
move into a 30,000-square-foot facility in Kinderhook, helping the company
to manage anticipated production growth and facilitate future expansion
needs. The company had been located in nearby Hudson.

Bio Medica signed a lease agreement and option to buy the facility from
Avoba Inc., a U.S. subsidiary of the Swiss-based firm Bioforce, AG. Bio
Medica may buy the facility at anytime for about $1.3 million.

Modifications for the Kinderhook facility cost about $74,000 which included
equipment and renovations. For future needs, the company is expected to
spend about $300,000 for expansion and development of manufacturing
facilities in addition to its marketing and general administrative program.

About 40 employees moved from the Hudson facility, said Melissa Decker,
manager of investor relations and corporate communications for the firm.
The company is planning to hold its annual shareholders meeting at the new
headquarters, 122 Smith Road, on Wednesday, Sept. 22.