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Tag: Chembio Diagnostics

  • Chembio Diagnostics, Inc. (CEMI) stock Dives Further Deep After Hours. Why?

    Chembio Diagnostics, Inc. (CEMI) stock Dives Further Deep After Hours. Why?

    Chembio Diagnostics, Inc. (CEMI) stock declined during the regular session on Tuesday, which continued sharply in the after-hours. While it lost 6.59% during regular trading, CEMI nose dived by 21.79% in the after-hours. No news from the company is responsible for the bearish momentum of the stock.

    During the regular session, CEMI traded between $1.55 and %1.70, closing the session at $1.56. The stock tumbled further down in the after-hours to reach $1.22 at 806.46K shares.

    Currently, the 30.05 million outstanding shares of the company trade at a market capitalization of $50.18 million.

    CEMI’s FDA De Novo/510(k) Request

    On December 06, CEI announced to have submitted De Novo/510(k) Request for the DPP SARS-CoV-2 Antigen test system to the FDA. Read with the DPP Micro Reader or DPP Micro Reader 2 optical analyzer, the test system can detect SARS-CoV-2 antigens within 20 minutes. Furthermore, it can also detect up to eight test results from a single patient sample.

    Moreover, the company was awarded to support the development of the COVID-19 point-of-care antigen test system using its proprietary DPP technology by BARDA. Biomedical Advanced Research and Development Authority (BARDA) is a part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. In addition to the funding for the clinical studies, BARDA’s support also included preparation of De Novo/510(k) submission.

    The company’s CEO and President, Richard Eberly shared his hopefulness for a straightforward review process with the FDA.

    SHAPRA Approval

    Previously, CEI had announced receiving SHAPRA approval for the DPP SARS-CoV-2 Antigen Test, on November 29. The South Africa Health Products Regulatory Authority (SHAPRA) approved the marketing and distribution of the test to professional healthcare providers.

    Richard Eberly remarked on the approval to be another proof of the strong sensitivity and specificity performance of the test system. Moreover, CEMI will now be providing an additional testing solution to its distributor, Patient Focus Africa (PFA), to its SARA-CoV-2 IgM/IgG Antibody test. Furthermore, the DPP SARS-CoV-2 Antigen test and the IgM/IgG Antibody test, both are authorized by the company’s distributor pursuant to SHAPRA’s license.

    Patient Focus Africa is accredited by the World Health Organization for near-patient testing, wellness, and professional point of care testing. Moreover, PFA is also owned partially by Discovery Health. Which is the largest private healthcare insurance provider in South Africa.

  • Is there any news of rising Chembio Diagnostics, Inc. (CEMI) stock today?

    Shares of the Chembio Diagnostics, Inc. (CEMI) stock were rising in the pre-market trading session today on July 26, 2021. The CEMI stock price saw an uptrend of 1.31 % to reach $3.10 a share at the time of this writing. The stock went down at the previous closing by 29%. Let’s deep dive to explore more of it.

    What’s Happening?

    CEMI is the developer and manufacturer of point-of-care (POC) diagnostic tests that help in the diagnosis of diseases. There is no news related to CEMI stock today to justify the bullish sentiment. It seems that the CEMI stock is rising without any obvious reason. However, it has been noticed that the stock became red at some points in the pre-market session today.

    CEMI stock’s Upcoming Financial Results:

    Chembio Diagnostics, Inc on July 23, 2021, announced the release date of its second-quarter 2021 financial results which is August 5, 2021. CEMI stock will announce financial results after the closing of trading on the above-mentioned date.

    CEMI stock’s first-quarter financial results:

    In the first quarter 2021 financial results, the CEMI stock generated $8.7 million revenue which was 27% higher than the same period of the prior year.Net products sales were declined 30% to drop at $4.0 million and the gross product margin was $0.5 million in the first quarter of 2021.

    The CEMI stock spent 46% higher research and development expenses in the first quarter of 2021 as compared to the same tenure of the previous year. Selling general and administrative expenses were increased by 46% or $1.9 million in the first three months of 2021.

    Net loss for the Chembio stock was $4.5 million as compared to $5.0 million in the prior-year period. As of March 31, 2021, cash and cash equivalents were totaled $14.4 million.

    COVID Diagnostic Test Order:

    On July 20, 2021, Chembio Diagnostics received a purchase order worth $28.3 million from Bio-Manguinhos. The order was related to Chembio’s DPP SARS-CoV-2 Antigen tests that use the nasal swab for detecting COVID-19 pathogen in only 20 minutes. As a result of this order, the shares of Chembio were doubled at that time.

    Conclusion:

    The CEMI stock was green in the pre-market trading session despite no specific news related to it on today’s date. The revenue of the first quarter was higher as compared to previous year same period. The upcoming financial results in august will further explain the position of this stock.

  • How Is Chembio (CEMI) Stock Skyrocketing 95% in Premarket Session?

    How Is Chembio (CEMI) Stock Skyrocketing 95% in Premarket Session?

    Shares of leading point-of-care diagnostic company focused on infectious diseases Chembio Diagnostics Inc. (CEMI) were trading up 94.66% at $4.01 in premarket trading on Wednesday. Chembio stock decreased -16.26% to end last trading session at $2.06. CEMI stock traded 1.39 million shares on the day, above its average daily trading volume of 0.48 million shares for the previous 50 days.

    In the last five days, CEMI stock share prices have retreated by -20.77; however, over the last month, they have fallen by -32.01%. Over the last three months, CEMI stock price plummeted by 43.25%, and so far this year, it has lost -56.63 percent. After receiving a multimillion-dollar order, CEMI stock has gained traction.

    Who placed the order with CEMI?

    Chembio is one of North America’s leading point-of-care diagnostics companies that specializes in detecting and diagnosing infectious diseases including COVID-19, respiratory disease, and insect-bite diseases. With CEMI’s vast scientific expertise, its novel DPP technology has a wide range of application beyond infectious diseases. Healthcare organizations, physician offices, clinical labs, government agencies, and consumers receive CEMI’s products directly and through distributors globally.

    Yesterday, Chembio announced that it had received a 28.3 million dollar purchase order from Bio-Manguinhos.

    • Chembio’s DPP SARS-CoV-2 Antigen tests for delivery during 2021 were ordered by Bio-Manguinhos to support an urgent need of the Brazilian Ministry of Health to fight the COVID-19 pandemic.
    • The DPP SARS-CoV-2 Antigen test, which uses a nasal swab to detect the antigen, uses a minimally invasive technique to detect COVID-19 infection in only 20 minutes.
    • Chembio’s supply chain, staffing, liquidity, and other matters outside Chembio’s control may prevent CEMI from delivering all the tests on the purchase order.
    • A small drop of blood from the fingertip or alternative samples allows CEMI to provide high-quality, rapid testing results in 15 to 20 minutes.
    • A single patient sample can produce up to eight test results using CEMI’s DPP platform, providing more clinical value than other rapid tests.
    • With CEMI’s highly portable, battery-powered DPP Micro Reader, users can easily and accurately perform certain types of decentralized testing where real-time results can be obtained while patients are still on the spot.
    • Objectivity produces results that reduce the potential for human error that can occur in many rapid tests requiring visual interpretations.

    A worthwhile investment by CEMI:

    Chembio (CEMI) significant expansion of customer relations with Bio-Manguinhos has been encouraging as it addresses COVID-19 testing needs. As a result of this purchase order, CEMI is set to ramp up its production of the DPP SARS-CoV-2 Antigen test, justifying the investments it made earlier in the year.