Precipio Launches Covid-19 Antibody Test in its CLIA laboratory
Precipio, a specialty diagnostics company (NASDAQ: PRPO), has completed the internal validation of its FDA-approved COVID-19 serology antibody test. The test is now commercially available to its pathology customers, marking the first phase of its rollout. Precipio aims to expand distribution to point-of-care facilities pending further FDA approval. The test offers a 24-hour turnaround with reimbursement of approximately $45 per test. The company plans to increase testing capacity from 1,000 to 10,000 tests per day by the end of Q3 2020. Management believes the company is adequately financed for its operational needs.
- FDA-approved COVID-19 serology antibody test now validated and commercially launched.
- Plans to expand distribution to point-of-care facilities as Phase 2.
- 24-hour turnaround for test results, enhancing service to customers.
- Current testing capacity of 1,000 tests per day, with plans to increase to 10,000 by Q3 2020.
- Reimbursement rate of approximately $45 per test.
- None.
NEW HAVEN, Conn., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced it has completed the internal validation of the FDA-approved COVID-19 serology antibody test in its CLIA laboratory, and has launched the test commercially to its pathology customer base (phase 1). Upon obtaining further approval for expanded use by FDA, phase 2 will broaden our distribution to POC (point-of-care) healthcare facilities including hospitals, medical centers, urgent care facilities and physician practices.
Physicians will be able to conduct a simple blood draw from each patient who wishes to be tested. The samples will be shipped overnight to Precipio’s laboratory in New Haven, where they will be received the next day, tested, and results shall be returned to the physician the same day, offering a 24-hour turnaround (subject to volume and capacity capabilities). Reimbursement is approximately
Physicians and other non-medical groups wishing to utilize our rapid testing services may contact us at covidtest@precipiodx.com, or by calling us at 203.787.7888.
While this ramp up has required a modest capital investment, management believes that the company is adequately financed, and has the appropriate access to capital for the company’s current operating cash needs, through its existing equity line. At this time, Management has not, and does not anticipate conducting a public offering in the foreseeable future.
“Providing immediate access and rapid results to our customer base is our first phase of commercializing our COVID-19 antibody test, in line with our strong level of service and commitment to our customers”, said Ilan Danieli, Precipio’s CEO. “As we continue to execute on our strategy, we aim to bring increasing value to our customers and to the company.”
About Precipio
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 and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.
Forward-Looking Statements
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.
The company’s forward-looking statements in this press release are based on management’s current views, beliefs, assumptions and expectations regarding future events and speak only as of the date of this release. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by the federal securities laws.
FAQ
What is the status of Precipio's COVID-19 antibody test?
When will Precipio expand its COVID-19 test distribution?
What is the turnaround time for test results from Precipio?
What is the reimbursement rate for Precipio's COVID-19 test?
How many tests can Precipio process daily?
