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Chembio Diagnostics Trims Q2 Revenue Outlook, Plans New EUA for Serology Test

NEW YORK ─ Chembio Diagnostics said after the close of the market on Monday that its preliminary second-quarter revenues are expected to be in the range of $4.5 million to $4.7 million and may increase by up to an additional $2.5 million for products shipped outside the US during the quarter. The forecast is nearly half the total revenues of $9.9 million that Chembio reported for Q2 2019.

For the three months ended June 30, Chembio said its COVID-19 test revenues would be in the range of $800,000 to $3.3 million. The additional $2.5 million for products shipped outside the US is included in the high end of the range, the firm said.

Hauppauge, NY-based Chembio said the decrease in revenues in Q2 2020 compared to Q2 2019 is due to the impact of the COVID-19 pandemic on historical products and markets; the company's shift to address the pandemic with a newly developed product; and seasonally stronger sales of HIV tests to Latin America during the prior-year period.

At the end of Q2, Chembio estimated it had cash and cash equivalents of approximately $36.6 million.

The point-of-care diagnostics company added that outside the US, it continues to ship its DPP COVID-19 IgM/IgG systems and pursue additional opportunities for them. Chembio said it also continues to monitor potential responses by regulators stemming from the US Food and Drug Administration's recent revocation of Emergency Use Authorization for the system. A National Cancer Institute validation recently found problems with Chembio Diagnostics' coronavirus serology test, setting the stage for the FDA to revoke the EUA it initially issued in April.

In a separate announcement on Monday, Chembio said its plans to submit applications to the FDA for EUAs for a revised version of the DPP COVID-19 IgM/IgG System, a COVID-19 point-of-care serology system, and a DPP COVID-19 Antigen System.

The DPP COVID-19 IgM/IgG System consists of Chembio's serology test for COVID-19 and a DPP Micro Reader analyzer. The company claimed on Monday that the NCI report acknowledges that the process ─ which evaluates COVID-19 serology test sensitivity and specificity using a panel of pre-selected samples ─ may not be indicative of performance in the real-world or performance of fingerstick blood used in the Chembio system.

Chembio said it is revising its system with the objective of meeting the new FDA criteria, including use of the NCI evaluation process, and that it anticipates applying for an EUA for the revised system during the third quarter.

The company further announced on Monday it has been awarded a $628,071 contract by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority. Chembio will use the funds to accelerate development of its DPP COVID-19 Antigen System, which it anticipates will consist of a DPP COVID-19 Antigen Assay and DPP Micro Reader. The antigen test system will use a respiratory specimen, such as a nasal or nasopharyngeal swab, in detecting SARS-CoV-2 antigens, the firm said.

Chembio added that the BARDA contract is further intended to assist it in applying for the FDA EUA for the antigen test system, and that it expects the funding will be distributed periodically over the next several months.