Chembio Diagnostics (CEMI.Q) today announced its launch of commercial distribution of an FDA Emergency Use Authorized, patent pending, rapid point-of-care COVID-19 antigen test for use in decentralized and traditional testing settings.

“We are now offering U.S. customers SCoV-2 Ag Detect™, a test for COVID-19 antigens in both symptomatic and asymptomatic populations, as well as Status™ COVID-19/Flu A&B, a product that differentiates flu from COVID-19 using a single nasal swab sample. Our expanded commercial team can now offer testing solutions for CLIA waived settings and work and school settings,” Charles Caso, Vice President of Sales and Marketing for Chembio.

You know what goes well with a fresh cup of coffee? Another article related to COVID-19, the pandemic we just can’t seem to get enough of. While I am sitting here complaining about it, companies like Chembio are on the frontlines battling the virus. So, who is Chembio? Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted diseases, fever and tropical diseases. With the amount of products the Company has under its belt, I’m surprised Chembio’s buckle hasn’t burst entirely. I may not be the greatest at counting, but just by taking a quick look at Chembio’s website I counted 19 products, many of which have been FDA approved. While the Company’s SCoV-2 Ag Detect™ (Detect™) and Status™ COVID-19/Flu A&B (Status™) are CE marked, meaning they meet EU safety requirements, both products have not yet been approved by the FDA.

 

However, the FDA has provided Emergency Use Authorization (EUA) for Detect™ and Status™ for use by medical professionals and laboratory personnel trained to perform these tests. Put simply, an EUA enables the FDA to authorize the use of unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases. With this in mind, Detect™ was manufactured by InBios International and is a rapid immunoassay test authorized for use in laboratories with a CLIA waiver certification. In addition to asymptomatic serial testing, this test can also be used for patients who are suspected to have COVID-19 by their healthcare provider within 5 days of symptom onset. Furthermore, it is able to provide results in just 20 minutes from a nasal swab and required no instrumentation.

“We believe this product is an important addition to our portfolio at a time when testing volume is increasing as Delta variant infections are on the rise. The United States has seen a spike in 7-day average confirmed COVID-19 cases from a 2021 low of 11,651 on June 18, 2021 to 133,056 as of August 18, 2021, per the U.S. Centers for Disease Control and Prevention tracking data,” continued Mr. Caso.

With regards to Chembio’s financials, the Company’s saw improvements in multiple areas. According to Chembio’s Q2 2021 Financial Results, the Company’s total revenue was $6.5 million, an increase of 26% year-over-year. Similarly, the Company’s net product sales increased by 4% to $3.9 million in the same period. More impressively, Chembio saw its government grant, license and royalty, and R&D revenue for Q2 2021 total $2.5 million, marking an increase of 92% year-over-year. As of June 30, 2021, the Company’s cash and cash equivalents totaled $5.6 million. More recently, on July 19, 2021, Chembio entered into an at the market offering agreement (ATM) with Craig-Hallum Capital Group, raising $36.9 million in gross proceeds.

 

 

Chembio’s share price opened at $3.06, up from a previous close of $2.69. The Company’s shares are up 16% and are currently trading at $3.14 as of 10:58AM ET.

Written By:

Kieran Robertson

Kieran Robertson is an experienced writer with a passion for technology, esports, and video games. He graduated from the University of Western Ontario with a Major in English Language and Literature. After graduating, Kieran worked as a freelance writer, managing his own blog and volunteering for La Maza Magazine, a magazine startup focused on collaborating with photographers, writers, models, and designers.

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Tags:
Health Science
Medical Devices
Robertson
CEMI.Q
Chembio Diagnostics
COVID-19
covid-19 testing
emergency use authorization
EUA
FDA
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