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Tag: OraSure Technologies

OraSure cuts ribbon on COVID-19 test manufacturing facility

Local officials gather to cut the ribbon at Opus Way, OraSure Technologies new COVID-19 rabid test manufacturing facility. PHOTO/SUBMITTED –

OraSure Technologies has officially cut the ribbon on Opus Way, its new expanded facility in Bethlehem Township, which was constructed with the help of $109 million from the U.S. Department of Defense (DOD) to ramp up production of InteliSwab COVID-19 rapid tests as part of the nation’s pandemic preparedness plan. 

“We have built the capacity to manufacture almost as many tests in a single week as we used to produce in an entire year … and we will continue to ramp production as we bring this new facility fully online,” said Carrie Eglinton Manner, president and CEO of OraSure Technologies. 

She called Opus Way a team effort – both within the organization and through OraSure’s partnerships with the federal and state government.  

“It is because of this collaboration that we are here together today for our official ribbon-cutting ceremony,” she said. 

OraSure was awarded a total of three contracts from the federal government last year to help develop, produce and distribute the COVID-19 test. Those included $205 million for InteliSwab COVID-19 Rapid Test procurement, $109 million for InteliSwab manufacturing capacity build out, and $13.6 million to pursue full FDA 510(k) clearance for InteliSwab. 

“These contracts position OraSure as an important part of the government’s global pandemic response,” said Lisa Nibauer, OraSure’s president of Diagnostics. “The U.S. government’s selection of OraSure’s InteliSwab rapid test for their national pandemic preparedness effort is a great honor.” 

OraSure names Quest exec as its new CEO

OraSure Technologies Inc of Bethlehem has a new president and CEO. 

The company announced this week that Carrie Eglinton Manner has been appointed to the post effective June 4. 

Eglinton Manner will also join the OraSure board of directors.  

She succeeds Nancy Gagliano, who was appointed interim CEO in March 2022. Dr. Gagliano will remain on the OraSure Board. Gagliano took over when former CEO Stephen Tang left the post.
The company said Eglinton Manner brings more than 25 years of healthcare leadership and transformation expertise to OraSure. She is currently senior vice president of Advanced & General Diagnostics Clinical Solutions, at Quest Diagnostics.  

Under her leadership, Quest’s Advanced Diagnostics, a portfolio with over $2 billion in revenue, accelerated its growth rate with strong profitability. She has responsibility for bringing innovative diagnostic solutions to market in the areas of women’s health, neurology, oncology, cardiovascular, metabolic, endocrinology, infectious disease and immunology testing services, as well as drug monitoring and toxicology. 

Additionally, she leads Quest’s pharmaceutical services, AmeriPath/Dermpath and international businesses. She led Quest’s molecular genetics team in pioneering next-generation sequencing innovation which reduced cost and increased access for patients to precision health insights. 

Prior to Quest Diagnostics, she served for 20 years in a variety of leadership roles of increasing responsibility including multiple, distinct business units with global engineering and manufacturing responsibilities at GE Healthcare, a division of General Electric (GE). A champion for inclusion and diversity, Eglinton Manner served as co-chair for Quest’s African American Employee Business Network, and prior to that, GE’s Women’s Network. 

“Carrie has a proven track record of transformative leadership, disciplined operational execution, and driving innovation at two industry-leading healthcare companies,” said Michael Celano, chairman of the board of OraSure. “Importantly, Carrie is a results-oriented executive who brings first-hand strategic insights on the testing industry and services businesses. The board is confident that Carrie’s experience and skillset make her ideally suited to lead OraSure as we continue to scale up manufacturing for InteliSwab and drive growth across all of our platforms.” 

Eglinton Manner’s appointment as CEO comes in tandem with a decision by the OraSure board to conclude its previously announced review of strategic alternatives and for the company to move forward under her leadership. Market conditions and the board’s belief in the company’s ability to further build upon recent operational successes with Carrie’s leadership were factors in the decision. 

Celano continued, “After completing a thorough review of strategic alternatives with the assistance of independent financial and legal advisors, the board believes the best path to create value is with improved execution and a renewed focus on driving profitable growth as a market leader in the areas of simple, reliable, point-of-care and home tests as well as innovative and easy-to-use sample collection technologies. We are excited to begin this next chapter in our company’s journey and want to thank our executive leadership team and all of our colleagues for their continued focus and dedication to our products and serving the needs of our customers around the world.” 

OraSure Technologies names interim CEO to replace outgoing Tang

Dr. Nancy Gagliano, MD –

OraSure Technologies Inc. Of Bethlehem has appointed Dr. Nancy Gagliano, MD to serve as interim CEO starting April 1.  

Stephen Tang Ph.D., current president and CEO, will be the leaving the company as of March 31. The Board’s search for a permanent CEO is actively underway. 

Gagliano is not a candidate for the permanent CEO position. 

  Gagliano, a member of the OraSure board since November 2021, brings extensive leadership experience in the diagnostics and healthcare industries to this role, including recent service as an executive leader of the National Institute of Health’s RADx Tech, a program focused on speeding the development, validation, and commercialization of innovative point-of-care and over-the-counter tests that can directly detect the COVID-19 virus.  

Gagliano, previously a practicing physician, has also held senior leadership positions at CVS Health, including as chief medical officer of Minute Clinic. 

“With decades of leadership in the diagnostics and healthcare industries, including helping to oversee the government’s widescale efforts to accelerate the development and commercialization of diagnostic tests for COVID-19, Nancy is well-suited to serve as interim CEO at OraSure,” said OraSure Chairman of the Board Michael Celano. “As she has demonstrated since joining the OraSure Board, Nancy is an engaged and thoughtful leader.  

He said that the OraSure board and senior leadership team continue to evaluate available strategic alternatives to maximize stockholder value and prepare for an orderly transition to a new CEO. 

OraSure CFO resigns, vice president of investor relations to hold interim role

OraSure Technologies in Bethlehem will be getting a new chief financial officer. 

The company, which makes tests for diseases such as HIV and COVID-19, said that CFO Roberto Cuca has resigned from the company with his last day being Sept.17. 

OraSure has initiated a search for a permanent chief financial officer with the capabilities and qualifications to support the company’s strategic goals. 

Both internal and external candidates are being considered for the role. 

In the meantime, Scott Gleason, senior vice president of investor relations and corporate communications will be serving as interim CFO. 

The company said in a release that Cuca left to pursue an opportunity within the healthcare industry. 

His departure was not related to any disagreements or disputes with the management or the board of directors of the company on any matters including the company’s accounting principles, practices, financial statement disclosures, or compliance procedures.  

“I would like to thank Roberto for his service to the Company and wish him well in his future endeavors,” said OraSure President and CEO Stephen Tang, Ph.D. “We remain confident in the outlook for the company as we have seen significant recent demand for our InteliSwab COVID-19 Rapid Test and continuing recovery of our core businesses. As an executive team, we are also focused on our current strategic review process with an eye toward driving long-term growth and shareholder value.” 

 

FDA needs more info before approving OraSure oral COVID-19 test

The U.S. Food & Drug Administration is requesting more information on the lab-based oral COVID-19 test being developed by OraSure Technologies.

The Bethlehem-based company asked the FDA for emergency use authorization for its SARS-CoV-2 Antibody ELISA, which is intended for the detection of total antibodies to SARS-CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device.

OraSure said it will resubmit two separate emergency use authorization requests for the ELISA and the oral specimen collection device.

The FDA has also requested that additional analytical studies be conducted on sample collection and stability.

“To date, there are no oral fluid antibody tests for COVID-19 authorized for sale in the U.S. As such, FDA’s guidance on EUA submissions for COVID-19 antibody tests focuses on blood samples for tests; the agency did not outline specific requirements for an oral fluid test. Consequently, we were unable to completely anticipate all of the data that would be required for a first-of-its-kind oral fluid antibody test,” said Dr. Stephen Tang, OraSure president and CEO.

The request is within the normal course of an FDA review and the company is confident that it will be able to provide the requested data, and resubmit its applications, according to Tang.

He said that some of the advantages of an oral antigen test, versus a blood draw, is that it is painless, non-invasive and requires less human contact, reducing exposure to potentially infected patients.

Bethlehem diagnostic developer’s saliva swab test to be used in COVID-19 lab testing

OraSure Technologies has developed a saliva collection device that’s been included in an FDA emergency authorization grant to a Syracuse medical diagnostic development company for COVID-19 lab testing.

Under the FDA’s Emergency Use Authorization, OraSure’s saliva collection device can be used to collect samples from individuals suspected of having COVID-19 by a health care professional, the Bethlehem-based medical technology company announced on Thursday. OraSure said the emergency authorization is the sixth to include a collection device from OraSure’s DNA Genotek subsidiary and the first to exclusively use its saliva collection method.

“Expansion of testing is a key to helping slow the spread of COVID-19 and safely reopen economies,” said Kathleen Weber, executive vice president and business unit leader of molecular solutions at DNA Genotek. “That’s why DNA Genotek is leveraging our expertise in non-invasive sample collection to provide more devices to more testing facilities, to help check millions of people around the world for COVID-19.”

Quadrant’s COVID-19 test kit was developed in partnership with SUNY Upstate Medical University and leverage’s the company’s existing specialization in RNA (ribonucleic)-based diagnostics. OraSure said in a statement that the swab test is a non-invasive test that’s easy to administer to determine the presence of SARS-Cov-2 viral RNA.

“The coronavirus has had a devastating effect on health and welfare worldwide, so it is extremely gratifying for us to take the expertise we have gained working on RNA diagnostic tests for other health conditions, such as autism spectrum disorder and Parkinson’s disease, and apply that expertise to the development of this critically important test,” said Richard Uhlig, founder and CEO of Quadrant Biosciences.

The saliva swab test will be immediately available for use by high-complexity clinical laboratories serving patients through physicians’ offices, urgent care clinics and hospitals, OraSure said in its Thursday announcement.

OraSure receives $630K to help develop oral test for coronavirus antibody

Bethlehem’s OraSure Technologies Inc. received nearly $630,000 to help develop an oral test for coronavirus antibodies.

The funds come from a contract with the federal Biomedical Advanced Research and Development Authority to develop an enzyme-linked immunosorbent Assay, or ELISA, which can be used for the detection of human anti-SARS-CoV-2 antibodies in oral fluid specimens. There currently are no oral fluid-based COVID antibody tests of the sort. The product is expected to increase laboratory COVID-19 antibody testing capacity.

OraSure said the support from BARDA will help it complete development of the ELISA and file for Emergency Use Authorization from the Food & Drug Administration to enter the U.S market.

The test could help identify people who had a COVID-19 infection, even without symptoms, potentially allowing them to safely return to work or other activities if data show antibody development translates to future immunity.

“The coronavirus pandemic is complicated and fast moving. It will take a variety of tests to get it under control,” said OraSure President and CEO Stephen S. Tang in a press release. “Understanding who is contagious and who has potentially protective antibodies will be crucial as the country continues reopening the economy and returning to everyday life. We believe that the combination of the OraSure antibody and antigen tests along with our sample collection capabilities, can give people insight into their COVID-19 status across the infection spectrum. We are proud to bring our proven expertise with oral fluid collection and testing to this global pandemic.”

This is the second COVID-related test for which the company has received BARDA funding. The first, a rapid, antigen in-home oral fluid self-test, was announced in April.

 

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