Following the receipt of FDA EUA by Nirmidas, Precipio begins market roll out to POC
NEW HAVEN, CT, (January 28th, 2021) - Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO) announces that following receipt of an Emergency Use Authorization from the FDA by Nirmidas Biotech, Inc., the developer and manufacturer of the COVID-19 antibody test, Precipio has begun to roll out these tests to the market.
After signing a sales and distribution agreement with Nirmidas earlier this week, Precipio has started with its installed oncology customer base, and will continue to expand into the market via additional sales channels. The test, produced by Nirmidas, a biotech company based in Palo Alto, CA is the first US-based product to receive EUA for point-of-care for its rapid COVID-19 antibody test.
As the nationwide rollout of the vaccine continues, the value of rapid antibody testing increases dramatically. First, to those who are deliberating whether to take the vaccine or not, the results of an antibody testing offers another important data point in making that decision. Individuals who have been infected with the virus (whether they display symptoms, or are asymptomatic), and subsequently develop antibodies that are detected by the COVID-19 antibody test, can use that result as another decision-making factor as they consider the vaccine. The test offered by Precipio employs the SARS-CoV-2 spike protein’s RBD antigen for detection, which is the specific binding target of neutralization antibodies resulting from vaccines or prior COVID-19 infection.
Additionally, given that the vaccine is designed to create a response that will cause the body to develop antibodies, the ability to test for the presence of these antibodies post-vaccination will provide an important tool for individuals and healthcare providers to assess the efficacy of the vaccine.
Precipio encourages all individuals to consult with their physician as to their decisions regarding testing, vaccination, and other decisions regarding their healthcare.
“We are excited to partner with Precipio to make our tests rapidly and widely deployed in the US for point-of-care testing” said Nirmidas CEO Dr. Meijie Tang. “We also look forward to developing a test that could be used in every household“.
“We are delighted to see the fruits of our work culminate in the ability to now bring this important test to the market, and contribute to the battle against this pandemic”, said Ilan Danieli, Precipio’s CEO. “The FDA continues to demonstrate their willingness to expand the reach and usability of these tests, and we hope to soon see progress on the at-home testing front as well”.
Based in Silicon Valley, Nirmidas combines chemistry, biology, bio-engineering, and optical imaging, with a focus on red to near-infrared fluorescence enhancement technologies. Commercialized applications include diagnostics and imaging for early disease diagnosis, prognosis monitoring, population screening, and therapeutics. Nirmidas was originally a spin-off from Stanford University and is a member of the StarX Med COVID-19 Task Force. Please visit www.nirmidas.com.
Precipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine, Harvard’s Dana-Farber Cancer Institute, and the University of Pennsylvania, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, among others, statements related to the expected or potential impact of the novel coronavirus (COVID-19) pandemic, and the related responses of the government, consumers, and the company, on our business, financial condition and results of operations, and any such forward-looking statements, whether concerning the COVID-19 pandemic or otherwise, involve risks, assumptions and uncertainties. Except for historical information, statements about future volumes, sales, growth, costs, cost savings, margins, earnings, earnings per share, diluted earnings per share, cash flows, plans, objectives, expectations, growth or profitability are forward-looking statements based on management’s estimates, beliefs, assumptions and projections. Words such as “could,” “may,” “expects,” “anticipates,” “will,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “predicts,” and variations on such words, and similar expressions that reflect our current views with respect to future events and operational, economic and financial performance, are intended to identify such forward-looking statements. These forward-looking statements are only predictions, subject to risks and uncertainties, and actual results could differ materially from those discussed. Important factors that could affect performance and cause results to differ materially from management’s expectations, or could affect the company’s ability to achieve its strategic goals, include the uncertainties relating to the impact of COVID-19 on the company’s business, operations and employees and the other factors that are described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis” in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated from time to time in the company’s Securities and Exchange Commission filings.
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