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News Article | May 9, 2017
Site: globenewswire.com

MEDFORD, N.Y., May 09, 2017 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, today reported financial results for the quarter ended March 31, 2017. John J. Sperzel III, Chief Executive Officer, stated, "We are pleased with the early results of the strategy to expand our commercial channels, focusing on the United States (U.S.), Latin America, Asia Pacific, Europe, and Africa. During the fourth quarter of 2016, we made key appointments to strengthen our commercial leadership team, and during the first quarter of 2017 we added experienced diagnostic sales executives in Latin America, Africa and Asia Pacific.  With this enhanced organization, we achieved a geographic mix of product sales for the first quarter of 2017, consisting of 39% of sales in Latin America, 26% in Asia Pacific, 20% in the U.S., 8% in Europe, and 7% in Africa. "During the quarter, the Company continued to expand its product portfolio by leveraging our patented DPP® technology platform, which we believe will result in near-term and long-term growth opportunities. The Company's product development strategy includes two primary objectives: 1) to strengthen our core business in the sexually transmitted disease market, and 2) to build a strong position in the fever and tropical disease market. "To strengthen our core business in the sexually transmitted disease market, the Company continues to focus on our DPP® HIV-Syphilis Assay in response to the global concerns related to co-infection and mother-to-child transmission of both HIV and Syphilis. During the first quarter of 2017, we received a CE mark for our DPP® HIV-Syphilis Assay, which allows us to market and sell the product within the member states of the European Union and in the Caribbean, except for Puerto Rico. The U.S. clinical trial to support our FDA application for the DPP® HIV-Syphilis Assay, which was initiated during the first quarter of 2016, has been completed. In March 2017, the FDA requested further clinical studies in addition to those recently completed.  As a result, Chembio is in discussion with the FDA regarding the timing of filing the Premarket Approval Application.  Another important development subsequent to the end of the first quarter of 2017 is that Chembio received a $5.8 million order from Bio-Manguinhos/Fiocruz to supply test components and intermediate product for the production of DPP® HIV 1/2 Assays in Brazil and subsequent supply to Brazil’s Ministry of Health.  We believe that substantially all of this order will be shipped prior to year-end 2017. To build a strong position in the fever and tropical disease market, we continue to make significant progress toward the goal of commercializing multiple products during 2017. During the first quarter of 2017, we initiated sales of our DPP® Zika Assay and our DPP® Zika/Dengue/Chikungunya Assay to the Centers for Disease Control and Prevention for use in a pilot surveillance program in Peru, India, Guatemala and Haiti. Also during the 2017 first quarter, we initiated sales of our DPP® Dengue Assay in Asia Pacific, and we continue to pursue important regulatory approvals for our DPP® Zika System with the U.S. FDA Emergency Use Authorization (EUA), World Health Organization Emergency Use Assessment And Listing (EUAL), and Brazil Agência Nacional de Vigilância Sanitária (ANVISA)." Addressing the Company's financial results, Mr. Sperzel commented, "During the first quarter of 2017, we achieved total revenue of $6.3 million which included product revenue of $5.4 million. While total revenue represented a 4.2% decrease from the first quarter of 2016, it is important to note that the first quarter of 2016 included approximately $1.8 million in product purchases by our previous U.S. distributor, while the first quarter of 2017, included approximately $1.4 million in sales from our recently acquired Malaysia subsidiary.  During the first quarter of 2017, we continue to see important quarter-on-quarter sales growth. "Within a number of geographic regions, we had several notable sales successes during the first quarter of 2017. In Asia Pacific, we achieved $1.4 million in product sales, driven by key tender wins in Malaysia, representing the first time the Company has achieved meaningful sales in Asia. In the U.S., we achieved $1.1 million in product sales, driven by a number of HIV tenders, which were won during the last two quarters, and much of which we expect to realize over the next 18 months. In Latin America, we achieved product sales of $2.1 million driven by sales to Brazil and, as mentioned above, we received a $5.8 million order from Bio-Manguinhos/Fiocruz and we believe that substantially all of this order will be shipped prior to year-end 2017. In Europe and Africa, we achieved $0.8 million in combined product sales, largely driven by HIV sales in the HIV self-testing and professional HIV testing business. “In closing, we believe the advances made during the first quarter of 2017 demonstrate our commitment to continue building global commercial channels, thereby strengthening our core business in the sexually transmitted disease market, and building a strong position in the high-growth fever and tropical disease market.” Selected Summary Financial Information comparing the 2017 first quarter with the 2016 first quarter: Total revenues for the first quarter of 2017 of $6.3 million decreased 4.2% compared with $6.6 million in the prior-year period. Product sales for the first quarter of 2017 of $5.4 million decreased 8.3% compared with $5.9 million in the prior-year period, again largely due to the $1.8 million of product purchases in the 2016 period by our former U.S. SURE CHECK® distributor, which did not make any material purchases after March 31, 2016.  R&D milestone, and grant and royalty revenues for the first quarter of 2017 of $0.9 million increased 31.2% compared with $0.7 million in the prior-year period. Gross margin dollars for the first quarter of 2017 of $3.1 million decreased 1.9% compared with $3.2 million in the prior-year period, due primarily to the decrease in product sales. The amount of product gross margin for the first quarter of 2017 of $2.2 million decreased 11.0% compared with $2.5 million in the prior-year period. R&D expenses for the first quarter of 2017 of $2.2 million increased 37.5%, compared with $1.6 million in the prior-year period. This increase is due primarily to increased clinical trial expenses as well as R&D activities for projects and grants. Selling, general and administrative expenses for the first quarter of 2017 of $2.5 million increased 24.5%, compared with $2.0 million in the prior-year period, largely due to increased wages and related costs, marketing materials, stock-based compensation, and travel, entertainment and trade shows, which were partially offset by decreased commissions on sales, decreased consulting, and decreases in investor relations expenses and professional fees. Operating loss for the first quarter of 2017 was $1.6 million, compared with an operating loss of $0.47 million in the prior-year period. Net loss for the first quarter of 2017 was $1.6 million, or $0.13 per diluted share, compared with net loss of $0.3 million, or $0.03 per diluted share, in the prior-year period. The Company had cash and cash equivalents of $5.6 million as of March 31, 2017, compared with $10.6 million as of December 31, 2016. The decrease was primarily due to cash used in operating activities for the first quarter of 2017, as well as cash used in investing activities. The Company’s working capital decreased by $2.3 million from $14.7 million as of December 31, 2016 to $12.4 million as of March 31, 2017. The Company had Accounts Receivable net of allowance for doubtful accounts of $5.7 million as of March 31, 2017, compared with $3.4 million as of December 31, 2016.  Cash and Accounts Receivable combined as of March 31, 2017 was $11.3 million as compared to $13.9 million at December 31, 2016.  During the months of April and May 2017 we collected $2.8 million of the March 31, 2017 accounts receivable balance. Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets each of its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally, both directly and through third-party distributors. Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products. Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Each of Chembio Diagnostic Systems, Inc. and RVR Diagnostics Sdn Bhd is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com. Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended.  Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management.  Such statements, which are estimates 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 the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products.  Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events.  Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.


MEDFORD, NY / ACCESSWIRE / May 8, 2017 / Chembio Diagnostics, Inc. (NASDAQ: CEMI) will host a conference call and live webcast to discuss the results of the 2017 first quarter, to be held Tuesday, May 9, 2017 at 4:30 PM Eastern Time. To participate, connect approximately 5 to 10 minutes before the beginning of the event. The replay will be available beginning approximately 2 hours after the completion of the live event, ending at midnight Eastern on May 16, 2017. Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets each of its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally, both directly and through third-party distributors. Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products. Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2017-02-08

Test devices determine the presence of a first ligand in a sample. Depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. Interim binding agents are used to enhance the test signal. A dual path immunoassay test cell device for detecting the presence of a first ligand in a sample is provided with a first sorbent material defining a first horizontal or lateral flow path and a second sorbent material defining a second horizontal or lateral flow path, the first and second sorbent materials overlying one another at a test site.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.43M | Year: 2011

DESCRIPTION (provided by applicant): Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis with an estimated two billion people currently infected worldwide and over nine million new cases detected annually worldwide. This is the largest killer of patients with HIV/AIDS. Current methods of diagnosis are complex, time-consuming, unreliable or unaffordable for most countries where the disease presents a significant public health threat. New diagnostics are critically needed to address the global tuberculosis burden and improve control programs. Our Phase I studies have clearly demonstrated the feasibility of developing a rapid and accurate test for tuberculosis. In collaboration with the Infectious Disease Research Institute, scientists at Chembio Diagnostic Systems, Inc. have identified a set of novel seroreactive antigens, designed several highly performing polyepitope fusion proteins, and applied the selected antigens in the Chembio's innovative immunoassay format, the Dual Path Platform (DPP(R)), with proven high accuracy of rapid serodiagnosis. We found that a DPP test prototype had a sensitivity of 81% and specificity of 95% in evaluations with serum samples obtained from culture-confirmed patients with active pulmonary tuberculosis from endemic regions in Brazil and Indonesia. In this Phase II application we propose to complete development and evaluation of the rapid diagnostic test for tuberculosis which will have required performance and operational characteristics. The specific aims are to: 1) optimize assay design, 2) determine diagnostic test performance, and 3) validate test production protocols in preparation for regulatory approval. We expect that the proposed DPP assay will demonstrate improved sensitivity and specificity over the existing rapid tests and will be applicable for expedited diagnosis of tuberculosis worldwide. PUBLIC HEALTH RELEVANCE: Tuberculosis remains one of the leading causes of mortality due to infectious disease worldwide. The current methods for diagnosis of tuberculosis are time-consuming, complex and laborious, and/or too expensive for routine use in resource-limited settings where most of patients live. The delayed or missed diagnosis leads to spreading of infection, progression of disease,and increased mortality. The research proposed here aims at developing a simple and rapid (20 minutes) point-of-care diagnostic test that would improve control programs by helping accurately detect new cases of tuberculosis, enabling timely antibiotic therapy, and preventing disease transmission. In addition to the visual reading, there will be an option for automated readout of the test result. The proposed assay will be fully validated and evaluated with serum samples from six countries representing various geographical areas and epidemiological setting associated with tuberculosis. These studies will demonstrate superior sensitivity and specificity as well as improved operational characteristics over the existing technologies.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2015-02-25

Test devices are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2015-02-25

Methods are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.


Grant
Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 599.78K | Year: 2016

Bovine tuberculosis (TB), a zoonotic disease caused by Mycobacterium bovis, continues to plague the cattle industry in the United States (US) and worldwide. Current diagnostic methods are inadequate; therefore, improved tests are urgently needed for disease control/eradication. The goal of the proposed research is to develop a simple, rapid, accurate, animal-side and cost-effective blood test for bovine TB in cattle. The assay will use Chembio proprietary Dual Path Platform (DPP) technology and rationally designed antigens of M. bovis to detect specific antibodies within 20 minutes under field conditions.Phase I studies have demonstrated the technical feasibility of the proposed approach. Several seroreactive antigens were identified which, when combined in our DPP assay, provided a diagnostic accuracy of ~95%. Proposed Phase II work has three technical objectives: 1) develop DPP BovidTB Assay, 2) evaluate test performance, and 3) validate the product in preparation for regulatory approval. Key antigen screening out of >100 novel M. bovis proteins will lead to designing efficient polyepitope fusion reagents for improved antibody detection. The DPP assay will be fully optimized and evaluated with extended panels of well-characterized serum specimens from cattle with confirmed M. bovis infection and from TB-free herds collected in the US, Brazil, the United Kingdom, and South Africa. Large-scale antigen production and DPP product manufacturing protocols will be validated. Portable optical readers will be evaluated to generate accurate quantitative data for objective DPP assay interpretation. Test performance evaluation results will be collected and analyzed to support regulatory submission.Upon successful completion of the Phase II work, Chembio will bring the new product to the US and international markets. The proposed research will be translated into significant commercial applications worldwide. The Chembio manufacturing facility in Medford, NY, is registered with FDA and licensed by USDA. The company has an extensive track record of new diagnostic product commercialization, including DPP VetTB Assay for captive cervids and elephants, and an established network of international distributors. A new blood test with superior performance and practical features will improve bovine TB control/eradication programs. Thus, the proposed research will meet the goals of the USDA Program Priorities and Societal Challenge Areas related to animal production and protection, and it will satisfy the public interest to increase food security and promote exports of agricultural biotechnology.


Grant
Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.65K | Year: 2015

Bovine tuberculosis (TB), a zoonotic disease caused by Mycobacterium bovis, continues to plague the cattle industry in the United States (US) and worldwide. Current diagnostic methods are inadequate; therefore, improved tests are urgently needed for disease control/eradication. The goal of the proposed research is to develop a simple, rapid, accurate, and cost-effective blood test for bovine TB in cattle. The assay will use proprietary Dual Path Platform (DPP) technology and rationally selected antigens of M. bovis to detect specific antibodies animal-side within 15-20 minutes under field conditions.Phase I has two technical objectives: 1) identify key antigens, and 2) develop a DPP test prototype. Novel M. bovis antigens will be screened out of a large panel of recombinant candidates using serum samples from M. bovis-inoculated cattle. Novel polyepitope fusions will be designed for highly sensitive multi-antigen cocktails providing >90% serodiagnostic accuracy. DPP test prototype will be evaluated with extended panels of well-characterized serum samples. Phase II studies will focus on product development, validation, and field evaluation in preparation for regulatory approval.The proposed research will be translated into significant commercial applications. The Chembio manufacturing facility in Medford, NY, is registered with FDA and licensed by USDA. The company has an extensive track record of new diagnostic product commercialization and an established network of international distributors. A new blood test with superior performance and practical features will improve bovine TB control/eradication programs. Thus, the proposed research will meet the goals of the USDA Program Priorities and Societal Challenge Areas related to animal production and protection, and it will satisfy the public interest to increase food security and promote exports of agricultural biotechnology.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2015-03-02

A test device for use with a liquid solution includes a housing that houses a plurality of sorbent strips. At least one strip has a location for receiving the solution. The housing defines at least an opening in said housing wherein said opening is aligned with the location for receiving the solution. The device includes a sealed reservoir filled with the liquid solution, the sealed reservoir being disposed in alignment with the opening and coupled to the housing. The device includes an opener coupled to the housing. The opener is arranged to rotate from a first position, in which the opener is not in contact with the sealed reservoir, to a second position, in which the opener causes the sealed reservoir to effect a release of the solution from the reservoir and into the opening and onto the sorbent strip housed within the housing.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2014-10-27

A single-use multiplex, or assay, screening test for the detection of one or more of a plurality of unrelated febrile illnesses is provided. The febrile illnesses for which the test is designed are unrelated, in that the illnesses may be caused, by way of example, by infection from viruses, bacterium and/or parasites; by infection from viruses, bacterium, parasites or other contagions that are animal borne; by infection from viruses, bacterium, parasites, or other contagions that can be aerosolized for transmission; by infection from viruses, bacterium, parasites or other contagions that are transmitted from direct contact; by infection from viruses, bacterium, parasites or other contagions that are generally transmitted in the tropics and/or subtropics; and/or by infection from a virus, bacteria, parasite sharing one or more related feature and which causes a febrile illness. The assay test provides rapid results to a point of care center or other facility requiring such results to facilitate treatment and or containment of the illnesses.

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