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Test Kit GSA Contracts; the Rise of American Bio Medica Corporation (OTCMKTS: ABMC)

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American Bio Medica Corporation (OTCMKTS: ABMC) is among the most exciting stories in small caps that saw a historic rise from $0.055 start point to highs of $1.26 earlier this year after the Company’s COVID-19 rapid test was authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories and is documented on the FDA website. ABMC has seen some choppy waters since than dropping below the $0.20 mark before a recent upwards surge in price and volume.

American Bio has been selling some of the world’s most effective point of collection tests for drug abuse for years and has significant established revenue streams from GSA government contracts. The Company is also backed by institutional investor; Stuart Sternberg, who is the owner of the MLB Tampa Bay Rays baseball team, and a seasoned hedge fund investor. Penny stock speculators noting the recent historic rise to $1.26 are accumulating at current levels.

American Bio Medica Corporation (OTCMKTS: ABMC) operating out of Kinderhook, New York is a biotechnology company that develops, manufactures, and markets accurate, cost-effective immunoassay test kits, including some of the world’s most effective point of collection tests for drugs of abuse. American Bio Medica Corporation (formerly American Micro Media Inc) was founded in 1992.  The Company and its worldwide distribution network target the workplace, government, corrections, clinical and educational markets. American Bio has a long proven history based on all the FDA approved products totaling over 100. The Company currently holds a GSA contract that is currently good through Jul 31, 2021.  GSA Schedules (also referred to as Multiple Award Schedules (MAS) and Federal Supply Schedules) are long-term government wide contracts with commercial firms providing federal, state, and local government buyers access to more than 11 million commercial supplies (products) and services at volume discount pricing. A GSA contract allows government agencies to immediately purchase without the need to go to public bid.

ABMC owns a valuable patent portfolio including 8 active patents for System and procedure for lateral flow immunoassay tests. Device and method for testing biological samples. Device and method for testing biological samples (Europe). Extraction method and apparatus for high-sensitivity body fluid testing device. Assay device and process for the testing of fluid samples. Method for stimulating saliva production during oral sample collection and Lateral flow immunoassay device and method.

The Company is led by CEO Melissa Waterhouse who joined ABMC in December 1997. Since that time she has held various management positions in Investor Relations, Marketing and Public Relations. She served as the Company’s 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.

American Bio has been selling FDA approved immunoassay test kits, including some of the world’s most effective point of collection tests for drugs of abuse for years and so it is no wonder they developed a covid 19 test kit; 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.

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American Bio’s COVID-19 rapid test was authorized by the FDA on May 29 under an Emergency Use Authorization (EUA) for use by authorized laboratories and it is currently documented on the FDA website. Pursuant to the obtained May FDA/EUA approval, as confirmed via e-mails from CEO Melissa Waterhouse, ABMC has shipped well over 1 million test kits.

On October 7 ABMC signed a distribution agreement with Co-Diagnostics, Inc. (CODX) granting ABMC the right to market and sell the Logix Smart Covid-19 tests in the United States on a non-exclusive basis. The test operates using a single step RT-PCR process in lower respiratory tract fluid samples such as bronchoalveolar lavage, sputum, tracheal aspirate, and upper respiratory tract fluid samples, such as nasopharyngeal and oropharyngeal swabs, obtained from patients who present with signs and symptoms for Covid-19, with easy-to-interpret results in under two hours.

ABMC will market the Covid-19 diagnostic test only to clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA), and in accordance with the Emergency Use Authorization issued to Co-Diagnostics, Inc. by the U.S. Food and Drug Administration on April 3, 2020.

Chief Executive Officer Melissa A. Waterhouse stated, “We are excited to offer our customers another testing solution for Covid-19. The Co-Diagnostic RT-PCR test enables us to offer customers a diagnostic tool that can be run on high-throughput machines. We can get a lot of necessary information from antibody testing over time and we believe there are a number of additional applications for antibody testing, but the need for diagnostic testing is still great in the US. The Co-Diagnostic RT-PCR test is a great complement to the Rapid IgG/IgM antibody test we already distribute.”

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Currently trading at a $7 million market valuation based on 35.9 million shares out and A/S capped at 50 million American Bio Medica is among the most exciting stories in small caps; the Company has been selling some of the world’s most effective point of collection tests for drug abuse for years and has significant established revenue streams from GSA government contracts; for the 6 months ended June 30, 2020 the Company reported $2,486,000 in sales up from 1.88 million for the same period last year. ABMC is backed by institutional investor; Stuart Sternberg, who is the owner of the MLB Tampa Bay Rays baseball team, and a seasoned hedge fund investor. American Bio Medica COVID-19 rapid test was authorized by the FDA on May 29 under an Emergency Use Authorization (EUA) for use by authorized laboratories and it is currently documented on the FDA website. Penny stock speculators noting the recent historic rise to $1.26 are accumulating at current levels. We will be updating on ABMC when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ABMC.

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Disclosure: we hold no position in ABMC either long or short and we have not been compensated for this article.

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IceCure Medical’s (NASDAQ: ICCM) ProSense: A 96.8% Success Rate Revolutionizing Breast Cancer Treatment

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On October 2nd, 2023, IceCure Medical (NASDAQ: ICCM) shares surged by over 50% following exciting news presented at a major medical event, the European Society of Breast Imaging. Their cutting-edge ProSense® System, designed for minimally invasive cryoablation, is marketed and sold worldwide for its cleared indications in the U.S., Europe, and China. More recently they gained approvals in India, and Brazil and have additional distribution through MC Medical to continue expanding in Europe. More importantly, the latest independent study confirms that the technology is a safe & effective outpatient procedure for breast cancer, with 96.8% success rate.

More Background:

Their system has the potential to revolutionize cancer treatment not only for breast cancer, but also for kidney, bone, and lung cancers. To date, the system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.

During the event, Dr. Lucía Graña-López, a radiologist specializing in breast and women’s imaging, led an independent study. The study explored cryoablation as a viable alternative to surgery for early-stage breast cancer in patients who preferred a non-surgical route. The results were promising, suggesting that cryoablation could be a successful treatment option, particularly for patients hesitant about traditional surgery.

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Clinical Study:

The study involved 31 patients with early-stage breast cancer who opted out of surgery, and the outcomes showed that cryoablation was well-tolerated with no major complications. This alternative approach could potentially be a game-changer, especially for breast cancer, which is one of the most prevalent cancers globally. Many patients, particularly older individuals, are seeking less invasive alternatives to surgery, making cryoablation an appealing option.

Dr. Graña-López envisions cryoablation becoming a significant alternative to surgery, particularly for early-stage breast cancer in post-menopausal women. Moreover she believes this technology could reshape how we approach treatment in other indications, particularly for kidney, lung, and thyroid gland cancers.

These results from this independent study are are in line with the ongoing ICE3 study, the largest of its kind in the U.S., set to conclude in early 2024.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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T2 Biosystems (NASDAQ: TTOO) Breaks Ground: FDA Clearance, Market Trends, and Healthcare Impact

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Shares of T2 Biosystems (NASDAQ:TTOO) are soaring up over 20% today on the heels of receiving a 510(k) clearance for its T2Biothreat from the FDA. This unique test directly detects six biothreat pathogens from a blood sample.

Spotting Biothreats Faster:

T2Biothreat Panel is a game-changer, being the first and only FDA-approved product that can spot these critical biothreat pathogens simultaneously. T2 Biosystems proudly stands as the first U.S. company to achieve this milestone, reshaping the field of biothreat detection.

Big Investor Sells:

Interestingly while celebrating this achievement, a significant investor, CR Group (CRG), decided to sell off a substantial chunk of shares. This sell-off, totaling 24.81 million shares, took place between Sept. 20 and Sept. 26. The timing of this sell-off alongside the FDA clearance raises some eyebrows.

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New CDC Guidelines:

Regardless of CR Group selling, there still appears to be a massive opportunity according to many retail investors. Following new CDC guidelines, the U.S. government now mandates that all hospitals in the country must adopt rapid testing protocols to combat the sepsis pandemic by 2026, or risk losing Medicare funding.

Buying opportunity of the year!!! Update
byu/den1183 inTTOOstock

T2 Biosystems stands as the exclusive FDA-cleared product capable of achieving 100% accurate sepsis detection within 3 to 5 hours. Anticipating widespread adoption of T2 instruments in hospitals, the CEO foresees significant revenue generation, potentially reaching $1.3 billion annually, given the mandate.

This development drastically alters the landscape, potentially influencing the stock’s trajectory positively. With the ongoing surge in manufacturing hires and likely acceleration in orders, coupled with potential government contracts or international sales, many beleive T2 Biosystems presents an undervalued opportunity for investors.

What Borrowing Costs Tell Us:

Another interesting indicator to look at is the cost to borrow (CTB) fee. In terms of TTOO’s case, the stock has seen a massive surge in CTB fees, indicating a high demand from short sellers. When compared to the average CTB fee for other stocks, it’s pretty drastic. While this is typically not a very positive sign, retail investors seem to be buzzing with interest, given there also could be a potential short squeeze if enough buying comes in to trap the shorts.

Better News for Patients:

But let’s not forget the real impact and that’s what TTOO can do for patients. @ChengKeki a user from Twitter also shared an article about Butler Memorial Hospital and their approach to Sepsis. The hospital came up with a 2 step approach to expedite patient care.  They’re utilizing the Beckman Coulter automation line to identify changes in a person’s blood cells that might indicate the development of sepsis. Which apparently has only been used in Europe and they’re the first in the US with the technology. Then shortly after, they use T2 Biosystems panels that as you know, quicken the process from 36 hours, to just 3-5 hours.

Catching sepsis quickly is crucial because it’s a life-threatening condition that rapidly progresses throughout your body and can lead to death if not promptly diagnosed and treated. Sepsis occurs when the body responds improperly to an infection, causing widespread inflammation and potentially damages multiple organ systems. Early detection allows for immediate medical intervention.

Conclusion:

T2 Biosystems is hitting major milestones, not only in the market but in improving critical healthcare processes. The company is also a major hit with retail investors and continues to trade an astronomical amount of shares daily, the current average is ~115M shares. The FDA approval and its implications, along with the positive shift in sepsis diagnosis, showcase T2 Biosystems’ growing role in healthcare. Keep an eye on how this progresses—it’s exciting for both investors and patients alike.

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Organogenesis (NASDAQ: ORGO): Latest Developments and Future Growth Prospects

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Organogenesis Holdings (NASDAQ: ORGO), a top regenerative medicine company dedicated to advanced wound care, surgical, and sports medicine solutions, gains over 30% during intraday trading and after hours combined after their latest release. According to the release, three Medicare Administrative Contractors (MACs) decided to withdraw certain coverage rules that were meant to start on October 1. These rules related to products for treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

More Background:

Organogenesis serves a range of clients, from hospitals and wound care centers to doctors’ offices. The MACs’ initial rules, set on August 9, caused concern. They specified that covered products must be particular types of skin substitutes. Unfortunately, this excluded five products from Organogenesis, impacting their financial outlook.

Fast forward, the MACs pulled back these rules just in time, preventing potential harm to Organogenesis. Even before these rules, the company was facing challenges. In the second quarter, revenue was slightly down compared to the same period last year. Despite this, the company is doing better than the previous year in a six-month comparison.

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Gary S. Gillheeney, Sr., the head of Organogenesis, expressed deep gratitude for the MACs and the Centers for Medicare & Medicaid Services (CMS). He praised their thoughtful consideration of stakeholder concerns and putting patients first. This decision will positively affect the lives of many.

He also thanked the stakeholders, including doctors, patient advocacy groups, and various associations. Their unified support played a vital role in challenging these rules, considering the potential harm they could cause patients. Their advocacy shed light on the possible negative health outcomes and treatment disparities, especially for those with higher rates of diabetes and related conditions. Their collective efforts made a significant difference.

We will update you on ORGO when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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