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CEMI has 20 products. So many patents
Infectious Disease Products
Our HIV and Syphilis rapid point-of-care tests are easy to use and ideal for the outreach setting.
DPP® HIV 1/2 Assay
DPP® HIV-Syphilis
HIV 1/2 STAT PAK® Assay
STAT-VIEW® HIV 1/2 Assay
DPP® Syphilis Screen & Confirm
SURE CHECK® HIV 1/2 Assay
SURE CHECK® HIV Self-Test
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Tropical & Fever Disease Products
Our Tropical and Fever Disease products are designed for urgent care settings and provide results in minutes.
Chagas STAT PAK® Assay
DPP® Zika IgM/IgG System
DPP® Zika IgM System
DPP® Ebola Antigen System
DPP® ZCD IgM/IgG System
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Respiratory Disease Products
Our Respiratory Disease tests based on our DPP technology platform require minimal training and are simple to run.
Status™ COVID-19/FLU
DPP® SARS-CoV-2 IgM/IgG
DPP® SARS-CoV-2 Antigen
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Handheld Analzyers
Our analyzers provides results in seconds directly at the point-of-care.
DPP® Micro Reader
DPP® Micro Reader II
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Veterinary Products
Our Vet products are licensed by USDA and are based on our DPP Technology platform which provides results rapidly.
DPP® VetTB Assay for Elephants
DPP® VetTB Assay for Cervids
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Chembio Germany
Chembio Brazil
Headquarters
Chembio Diagnostic Systems, Inc.
555 Wireless Blvd.
Hauppauge, NY 11788
+1-631-924-1135
https://chembio.com/products/#tropical-and-fever-disease-products
grabbed a few at 4.30sss
big possibility
agree!
CEMI loading 5.80ss
BSQR seems the next CEMI
CEMI 6.58
NEWS~Chembio Diagnostics Receives $4 Million HIV Test Purchase Order Supported by The Global Fund
July 22 2021 - 12:49PM
GlobeNewswire Inc.
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, announced its receipt today of a $4 million purchase order from the Partnership for Supply Chain Management (PFSCM), supported by The Global Fund, for the purchase of Chembio’s HIV 1/2 STAT-PAK Assay for shipment to Ethiopia into early 2022. Chembio’s delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembio’s supply chain, staffing, and liquidity, and other matters outside Chembio’s control.
The HIV 1/2 STAT-PAK Assay is a World Health Organization (WHO) prequalified, rapid point-of-care assay for the detection of HIV-1 and HIV-2 antibodies in fingerstick whole blood, venous whole blood, serum, or plasma. With 99.7% sensitivity and 99.9% specificity, the HIV 1/2 STAT-PAK Assay is the only HIV test that exceeds WHO performance thresholds according to an independent, multi-site study published in the Journal of the International AIDS Society in 2017. Its innovative design can be performed in three simple steps with minimal training, requires only 5 microliters of blood, and includes a built-in biological control. A version of the HIV 1/2 STAT-PAK Assay for the U.S. market has received premarket approval (PMA) and a Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration.
“We are proud to continue our support of The Global Fund’s pursuit of UNAIDS’s ‘90-90-90’ targets,” said Richard L. Eberly, Chembio’s President and Chief Executive Officer. “We look forward to working closely with PFSCM to continue the supply of our high-quality HIV tests to help the people of Ethiopia know their HIV status and obtain treatment.”
Chembio was first awarded the front-line testing algorithm position in Ethiopia in 2018 to screen for HIV. With this latest purchase order, Chembio is continuing that important role, now under the contractual auspices of The Global Fund, and expanding its longstanding relationship with PFSCM, which leverages its planning and logistics resources for clients, governments, and nongovernmental organizations (NGOs) in over 85 countries.
Testing for HIV across Africa and Asia fell by 41% during the period from April to September 2020 compared to the same period in 2019, according to an April 2021 report by The Global Fund on the disruptive impact of the COVID-19 pandemic, despite The Global Fund’s actions to continue essential HIV services and protect healthcare workers. The Joint United Nations Programme on HIV/AIDS (UNAIDS) has identified “90-90-90” targets under which 90% of HIV-positive people will know their status, 90% of HIV-positive people who know their status will be on HIV treatment, and 90% of people on HIV treatment will have achieved viral suppression and have undetectable levels of HIV in their bodies.
About Chembio Diagnostics
Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted, respiratory and insect vector diseases. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.
Forward-Looking Statements
Certain statements contained in the first and third paragraphs above are not historical facts and may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to manufacturing, distribution, and sale of the HIV 1/2 STAT-PAK Assay pursuant to the purchase order from PFSCM. Such statements, which are expectations only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events or performance may differ materially from forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the following, any of which could be exacerbated even further by the continuing COVID-19 outbreak in the United States, Ethiopia, and globally: constraints on Chembio’s supply chain, staffing, and other resources that could inhibit Chembio’s ability to deliver the number of tests contemplated by the purchase order from PFSCM; the need for Chembio to obtain sufficient working capital to fund the procurement of raw materials, the employment and recruitment of personnel, and other costs associated with manufacturing tests, as well as Chembio’s ongoing operational infrastructure; the risks of doing business with foreign governmental entities, including geopolitical, international, and other challenges; the ability of Chembio to maintain existing, and timely obtain additional, regulatory approvals for its HIV tests, which approvals are subject to processes that can change recurringly without notice; and, the highly competitive market for testing solutions for HIV, which includes a number of competing companies with strong relationships with current and potential customers, including governmental authorities, and with significantly greater financial and other resources that are available to Chembio. Chembio undertakes no obligation to publicly update forward-looking statements in this release to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to the forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's periodic public filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and its subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, particularly under the heading “Risk Factors.” Readers should interpret many of the risks identified in these reports as being heightened as a result of the ongoing and numerous adverse impacts of the COVID-19 pandemic.
DPP and STAT-PAK are Chembio’s registered trademarks. For convenience, these trademarks appear in this release without ® symbols, but that practice does not mean that Chembio will not assert, to the fullest extent under applicable law, its rights to the trademarks.
Contact:
Philip Taylor
Gilmartin Group
(415) 937-5406
investor@chembio.com
CEMI seems the next NURO
BSQR~($3)~hit the floor
NEWS~WISA’s Wave Campaign Continues to Build WiSA Certified Category with New Store on Amazon Featuring WiSA Products and Retailer Bundles Available Across Amazon’s Vast Platform
https://finance.yahoo.com/news/wisa-wave-campaign-continues-build-110000935.html
87 million volume so far!
possible CEMI can be the next NURO
CEMI~~ here we goo to 7+
WISA~ GREAT VOLUME
Chembio Diagnostics Receives $28.3 Million Purchase Order from Bio-Manguinhos for DPP SARS-CoV-2 Antigen Tests in Brazil
HAUPPAUGE, N.Y., July 20, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, announced its receipt today of a $28.3 million purchase order from Bio-Manguinhos for the purchase of Chembio’s DPP SARS-CoV-2 Antigen tests for delivery during 2021 to support the urgent needs of Brazil’s Ministry of Health in addressing the COVID-19 pandemic. The DPP SARS-CoV-2 Antigen test is designed to detect the SARS-CoV-2 antigen, which indicates an active COVID-19 infection, in only 20 minutes using a minimally invasive nasal swab. Chembio’s delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembio’s supply chain, staffing, and liquidity, and other matters outside Chembio’s control.
Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation (Fiocruz), is responsible for the development and production of vaccines, diagnostics, and biopharmaceuticals, primarily to meet demands of Brazil’s national public health system. Chembio has a long-standing relationship with Bio-Manguinhos, having supplied multiple products for point-of-care detection of COVID-19 antibodies, HIV, and other infectious diseases. Bio-Manguinhos received regulatory approval from Agência Nacional de Vigilância Sanitária (ANVISA) in March 2021, following ANVISA approval of the test for Chembio’s Brazilian subsidiary in November 2020.
“We are pleased to significantly expand our customer relationship with Bio-Manguinhos to address the testing needs surrounding COVID-19,” said Javan Esfandiari, Chembio’s Executive VP, Chief Science & Technology Officer. “Enabling providers to test patients at the point-of-care and determine their infection status in only 20 minutes can be one of the most effective methods for controlling the spread of COVID-19 and improving patient outcomes. We believe the purchase order validates the investments we made earlier this year in inventory for the DPP SARS-CoV-2 Antigen test and look forward to ramping up production. We are very proud to provide this test in Brazil and assist in efforts to manage the global pandemic.”
About the DPP Rapid Test Platform
Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.
Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA). Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, ANVISA, and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions.
All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending.
About Chembio Diagnostics
Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted, respiratory and insect vector diseases. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.
CEMI hit 6.37 pre-market
Good morning Great stock
Probably they shorted..
great stock goes up fast.. I believe loading zone
big volume today!
big possibility
VWAP 5.87, VOLUME 374 MILLION
BSQR is getting ready
BSQR seems the next CEMI
grabbed a few
AWESOME STOCK!
Agree!
CEMI~ stock of the day
CEMI~108% up, volume crazy!
CEMI~107% up, volume crazy
CEMI~pre-market 92% up
CEMI~pre-market 92% up
NURO pre-market 32% up >>>>
NURO pre-market 32% up >>>>
NURO pre-market 33% up >>>>
NURO pre-market 33% up >>>>
Awesome run even after hours
Market cap already too small for a FDA approved stock
NURO~NeuroMetrix Receives FDA Breakthrough Device Designation for Treatment of Fibromyalgia with its Wearable Neurostimulation Tec...
July 20 2021 - 09:00AM
GlobeNewswire Inc.
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its Quell® device has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for treating the symptoms of fibromyalgia in adults.
Fibromyalgia is a common form of chronic pain that is also accompanied by fatigue, sleep, cognitive and mood disturbances. It affects an estimated 2 to 6 percent of the U.S. population (5 to 15 million people) and is most often diagnosed between the ages of 30 and 50. The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. Although several drugs are FDA approved for managing fibromyalgia pain, there is an unmet need for safe and effective non-pharmacological treatments.
Quell is an advanced, non-invasive, nerve stimulation device that is covered by 18 U.S. utility patents. It is the only wearable neurostimulator that is enabled by a custom designed microchip that provides flexible, precise, high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with the Quell app, which is available for iOS and Android mobile devices.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide NeuroMetrix with priority review and interactive communication regarding device development, through to commercialization. In addition, there are government policies and programs under consideration that, if eventually adopted, may facilitate Medicare reimbursement for FDA Breakthrough Devices following marketing authorization.
The data submitted by NeuroMetrix in support of the Breakthrough Designation included results from a double-blind, randomized, sham-controlled trial (NCT03714425). A total of 119 subjects with fibromyalgia were enrolled and randomized to a standard (active) or modified (sham) Quell device for 3-months of at-home use. In an intention-to-treat (ITT) analysis of all subjects, 56% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life (Fibromyalgia Impact Questionnaire, FIQR) compared to 35% that received sham treatment (p=0.029). There were additional positive outcomes in both the ITT population and in a pre-specified subgroup analysis of subjects with elevated pain sensitivity based on Quantitative Sensory Testing (QST).
“The Breakthrough Device Designation is an important milestone in the Company's effort to make Quell technology available to people living with fibromyalgia,” said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. “We are moving forward with a regulatory filing that could position us to launch Quell for this indication in the second half of next year.”
Note: The use of Quell for fibromyalgia is investigational and has not been cleared or approved by the U.S. FDA. The safety and effectiveness for this purpose have not been reviewed by the FDA.
About Quell
Quell is a novel transcutaneous electrical nerve stimulator (TENS) that is indicated for symptomatic relief and management of chronic lower extremity (knee, foot and leg) pain and is available over-the-counter. It is a wearable device that can be used during the day while active and at night while sleeping. Quell users can personalize and manage therapy discreetly via the Quell app. Quell also offers health tracking metrics relevant to chronic pain sufferers. Quell users can synchronize their data with the Quell Health Cloud®, which provides customized feedback and powers a large chronic pain outcomes database. Visit QuellRelief.com for more information.
About NeuroMetrix
NeuroMetrix is an innovation-driven company focused on the development and global commercialization of non-invasive medical devices for the diagnosis and treatment of pain and neurological disorders. The Company has three commercial products. DPNCheck® is a diagnostic device that provides rapid, point-of-care detection of peripheral neuropathies. ADVANCE® is a diagnostic device that provides automated, in-office nerve conduction studies for the evaluation of focal neuropathies. Quell® is a wearable neurostimulation device indicated for treatment of lower extremity chronic pain. For more information, visit www.NeuroMetrix.com.
Source: NeuroMetrix, Inc.
Thomas T. Higgins
SVP and Chief Financial Officer
781-314-2761
neurometrix.ir@neurometrix.com