Chief Executive Officer/ Principal Accounting and Financial Officer
Melissa Waterhouse joined ABMC in December 1997. Since that time she has held various management positions in Investor Relations, Marketing and Public Relations. She served as our Corporate Secretary from September 2003 until her interim appointment as Chief Executive Officer and Principal Financial Officer in October 2013. In June 2014, Ms. Waterhouse was appointed as Chief Executive Officer and Principal Financial Officer and was appointed to the Board of Directors.
Vice President of Operations.
Douglas Casterline has served as our Vice President, Operations since July 2012. Mr. Casterlin originally joined the Company in 1997. Mr. Casterlin has over 30 years experience in manufacturing and production.
Scott D. Hutton, Ph.D.
Vice President of Sales & Marketing
Scott D. Hutton, Ph.D. has been with ABMC for over 8 years and, he has over 18 years of experience in the drug testing industry. He has negotiated numerous state contracts as well as contracts with Fortune 500 Companies. Prior to being in the drug testing industry, he had over 15 years of law enforcement and corrections management experience. Dr. Hutton has written a book entitled, “Staff Supervision Made Easy” and served in the U.S. Army.
REGULATION FD DISCLOSURE
On March 20, 2020, American Bio Medica Corporation (the “Company”) announced in a press release and Form 8-K that it was offering a COVID-19 Antibody Rapid Detection Kit to detect COVID-19 in whole blood, serum or plasma via finger stick. On May 29, 2020, the COVID-19 test being distributed by the Company was authorized by the United States Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for use by authorized laboratories. The product, manufactured by Healgen Scientific, LLC, has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. The product is intended for professional use and not for home use. The Company will continue to market the COVID-19 test in full compliance with FDA policy and the EUA.
The information in this Item 7.01 is furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section.
PUBLISHED 8:58 AM ET Apr. 27, 2020
HILLSBOROUGH COUNTY, Fla. -- Widespread coronavirus testing could be available for first responders in Hillsborough County as early as this week.
These are rapid testing kits that will determine who has the virus, which will help the department pinpoint who may have been exposed.
As COVID-19 quickly spread across the country, first responders accounted for some of the earliest cases, even here in Hillsborough County.
"We had four members test positive for COVID-19. We've had over 60 members tested. We've had numerous folks exposed, isolated, or quarantined," Deputy Chief Jason Dougherty said.
That's why it was so important for Hillsborough County to test all of its first responders. The county shelled out about $250,000 for 44,000 rapid COVID-19 testing kits.
"The test will tell them whether they've been exposed to the COVID-19 virus or whether they have COVID-19," Dougherty said.
First responders in municipalities like Tampa will also have access to the rapid testing kits and so will staffers at nursing homes.
The county ordered the kits from American Biomedica, a New York-based company.
While this particular test hasn't been reviewed by the FDA, the government allowed it to be used under an emergency act.
Several of those testing companies have come under fire for results that yielded false positives and false negatives. However, according to Chief Dougherty, any results that come back will have to be confirmed by the Florida Department of Health.
"It's an important step for members to give them a piece of mind but also to protect the citizens in the community and make them feel safe and comfortable with our folks responding to the emergency," Dougherty said.
The testing kits could arrive as early as Wednesday.
–Company expects distribution would materially impact sales–
Kinderhook, N.Y., March 23, 2020 – American Bio Medica Corporation (OTCPK: ABMC), a manufacturer of accurate, cost-effective immunoassay test kits, announced today that it began offering on March 17, 2020, via a distribution partnership, a Rapid Test to detect Covid-19 in whole blood, serum or plasma. The assay offers qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus (Covid-19) and provides results in as few as 2 minutes and generally not more than 15 minutes. The test has not yet been reviewed by the U.S. Food and Drug Administration (FDA), but is being offered under the March 16, 2020 guidance set forth by the FDA.
The test can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic and can be used across many markets including hospitals, clinics, and by employers and correctional institutions. The test is not available for consumer use and will be marketed in full compliance with the FDA guidance, including the required labeling indicating that antibody testing should not be used as the sole basis to diagnose or exclude a Covid-19 infection.
To place an order, customers can call (800) 227-2343, or (518) 758-8158 outside the United States or, contact the company via email at COVID19@abmc.com
For more information on ABMC or its testing products, please visit www.abmc.com