BioReference Laboratories, Inc., a subsidiary of OPKO Health (NASDAQ: OPK) with numerous patient service centers across the United States, is offering both a direct test for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes the Coronavirus Disease COVID-19, and a test for antibodies targeting the virus. Here is the latest news and updates related to the COVID-19 and coronavirus antibody screening tests offered by OPKO Health.
The company has previously developed diagnostic tests for infectious diseases in collaboration with the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC).
- OPKO Health Subsidiary BioReference Laboratories to Offer COVID-19 Test
- OPKO Health to Begin Offering Coronavirus Tests in New York
- Partnership Announced with New York City Health and Hospital Corporation
- Coronavirus Testing Collaboration Initiated with State of New Jersey
- City of Detroit Partners with OPKO for COVID-19 Testing
- Miami, Florida, Will Offer Drive-Through COVID-19 Testing
- Nearly 200,000 Tests To-Date with Partners Nation-wide
- OPKO Health to Offer Tests for Coronavirus Antibody Screening, Assesses Immunity to Virus
- New York City to Offer Antibody Screening Tests
- Program for Antibody Screening of Employees Announced
OPKO Health Subsidiary BioReference Laboratories to Offer COVID-19 Test
On March 5th, 2020, Executive Chairman of BioReference Dr. Jon R. Cohen M.D., who attended the Coronavirus Task Force meeting at the White House, stated, “COVID-19 testing is imperative in aiding front-line healthcare professionals and public health authorities to identify infected patients more quickly, limit the spread of infection and promote earlier diagnosis and treatment.”
“We want to specifically recognize how engaged and responsive HHS, the CDC and the FDA have been in helping us navigate quickly through the scientific and regulatory issues necessary to make testing available as soon as possible to the U.S. population,” Dr. Cohen continued.
OPKO Health to Begin Offering Coronavirus Tests in New York
On March 13th, 2020, OPKO Health announced that it would begin offering tests for COVID-19 in the state of New York. Dr. Jon Cohen stated, “Cases of COVID-19 are increasing across the US, making access to testing a critical component in helping healthcare providers identify infected patients more quickly. BioReference has been working expeditiously to develop and offer this test that will yield high-quality and accurate results.”
“I believe that the private sector should be part of the solution in controlling the COVID-19 outbreak and am proud that BioReference can assist Governor Cuomo as he leads New York State through this crisis,” Dr. Cohen continued.
Partnership Announced with New York City Health and Hospital Corporation
On March 17th, 2020, OPKO Health announced that it would provide COVID-19 testing for the New York City Health and Hospital Corporation, which is the largest public healthcare system in the United States, serving over one million patients each year.
New York City Mayor Bill de Blasio stated, “This expanded testing for H+H is critical to protecting the New Yorkers most at risk in this epidemic, especially our seniors and people with chronic health problems. We are in a race against time, and we are trying to rapidly make up the ground lost by the federal government in the initial weeks of this crisis. The new partnership between H+H and BioReference means increased testing and faster results—helping save lives.”
Dr. Jon Cohen stated, “In support of the public health system as they provide healthcare to vulnerable and at-risk populations, BioReference is committed to prioritizing hospital patients suspected of COVID-19 infections and aid front-line physicians and healthcare providers to quickly and efficiently diagnose patients. In addition to the drive-through facilities, this collaboration is yet another example of how the private sector can assist with government agencies to help combat this epidemic.”
Coronavirus Testing Collaboration Initiated with State of New Jersey
New Jersey Governor Phil Murphy stated, “Expanded testing is imperative to protecting the people most susceptible to this epidemic, specifically senior citizens, people with chronic health problems, and those with compromised immune systems. We are grateful for this partnership with BioReference, as it means the people of New Jersey will have increased access to testing and faster results, helping limit the spread of COVID-19.”
Dr. Jon Cohen stated, “To support the high demand for convenient and efficient COVID-19 testing, BioReference and the State of New Jersey, the home of our main laboratory, have collaborated to expand access to testing across the State by providing an additional 10,000 tests to New Jersey residents.”
“In addition, we are working with five counties directly in opening drive-through testing locations and will expand from there. It is a privilege to offer testing to residents of New Jersey, where the majority of our 4,000 employees live,” Dr. Cohen continued.
City of Detroit Partners with OPKO for COVID-19 Testing
Detroit Mayor Mike Duggan stated, “The impact that expanded testing will have on residents of the City of Detroit is immeasurable. Myself, and the residents of this great city are grateful for our relationship and partnership with BioReference.”
Dr. Jon Cohen stated, “This is another example of BioReference assisting local governments around the country to provide COVID-19 testing. In addition to providing the residents of Detroit increased access to testing, there are first responders in the city who are waiting to get tested and we are privileged to support the exposed men and women on the front-lines in Detroit.”
Miami, Florida, Will Offer Drive-Through COVID-19 Testing
Miami Mayor Francis Suarez stated, “We all are responsible for helping to control the spread of this virus. As an individual who tested positive for COVID-19, I have a duty to the City of Miami to bring my city’s residents access to testing and information, and through our partnership with BioReference, we can help address this public health crisis.”
“BioReference continues to prioritize expanding public access to COVID-19 testing across the nation. The importance of high-quality, reliable, scalable laboratory tests available is a critical part of the response in the effort to contain COVID-19,” stated Dr. Jon Cohen.
Nearly 200,000 Tests To-Date with Partners Nation-wide
Dr. Jon Cohen stated, “Our goal is to maintain the current 24 hour turnaround time for these patients. Nothing is more important than getting a timely result back to the medical personnel on the front lines making treatment decisions on a minute-to-minute basis.”
“Multiple types of hospitals, for-profit, not-for-profit, large health systems, individual hospitals, academic medical centers, and community hospitals have all reached out to get their results in a timely fashion. We have now tested almost 200,000 patients and will continue to grow our capacity from 20,000 tests/day to 35,000 tests/day within the next week.”
“While prioritizing hospital patients, at the same time we will continue to strive to keep our current turnaround time for non-hospital patients at 2-3 days from the time we receive the specimen,” Dr. Cohen continued.
OPKO Health to Offer Tests for Coronavirus Antibody Screening, Assesses Immunity to Virus
On April 29th, 2020, OPKO Health announced that it would offer a blood-based test for antibodies targeting the virus that causes COVID-19. The test, a high-throughput semi-quantitative immunoassay, will be offered by healthcare providers across the nation and evaluate the humoral immune response to the virus.
Dr. Jon Cohen stated, “Testing for antibodies is the next logical step to help employers and employees countrywide make decisions as to how to move forward with their jobs and personal lives.”
“We are proud to partner with New York State to identify employees’ antibody levels and areas of the population with varying levels of antibodies, types of populations that may be at a higher risk of infection, individuals who may be possible plasma donors of convalescent serum and data that can be helpful when deciding on how to roll out a vaccine when it becomes available.”
New York City to Offer Antibody Screening Tests
Mayor Bill de Blasio stated, “So many New Yorkers are wondering whether they’ve had the virus, or if they’ve exposed their own families. While antibody tests are not a fix-all solution, they will give our communities the knowledge they need to help us defeat this virus together.”
Dr. Jon Cohen stated, “BioReference is supporting the city in its epidemiology studies of the presence of COVID-19 throughout large segments of the New York City population. For New York, a city that has been seriously impacted by the COVID-19 pandemic, this type of information will be of great value in helping healthcare professionals to analyze the presence and progression of the disease in order to identify at risk populations for possible early intervention.”
Program for Antibody Screening of Employees Announced
Dr. Jon Cohen stated, “For employers, COVID-19 screening for antibodies is one additional piece of information to help guide decisions about moving forward. Antibody testing can provide employers key information about who might have been exposed or infected, and who may potentially be immune from re-infection.”
“It’s our responsibility to add to the body of knowledge for this virus, and we believe antibody screening can be helpful to guide us toward a new normal.”
Following a meeting with the Coronavirus Task Force at the White House, President of the American Clinical Laboratory Association (ACLA) Julie Khani stated, “We appreciated the opportunity to meet with Vice President Pence and members of the White House’s Coronavirus Task Force this afternoon on the critical issues related to testing capacity.”
“As an industry, clinical labs have taken steps to meet the growing demand for national testing and are working together with the Administration, the CDC and FDA as well as state and local public health labs, hospitals and academic medical centers. Currently, clinical labs are working around the clock to bring new tests online with the goal of processing several thousand tests in the coming days.”
According to the ACLA, “In any outbreak, Centers for Disease Control and Prevention (CDC) laboratories, supported by state public health laboratories, have primary responsibility for diagnosing patients. In recent public health emergencies, including the SARS and Zika outbreaks, commercial laboratories have supported public response and expanded test capacity.”
Ms. Khani continued, “On Saturday, February 29, the FDA issued new guidance for high complexity laboratories, including commercial laboratories, to perform coronavirus testing as soon as validation is complete. Prior to Saturday’s announcement, ACLA members were already working to develop novel tests for COVID-19 and remain in close communication with our public health partners at the CDC.”
“As of Wednesday, March 4, 2020 ACLA members are not yet collecting, processing or transporting specimens for COVID-19 testing from patients suspected of having, or confirmed to have, COVID-19.”
“ACLA is committed to supporting our public health partners and rapid response efforts. We’re working closely with our members—and in close coordination with state and local public health labs, hospitals, the CDC and the FDA—to increase overall national capacity. Over the next several weeks, commercial labs are working to bring online additional testing capacity at which point we will have a more informed assessment on the number of tests that can be processed.”
According to a recent press release, BioReference Laboratories is “expecting to receive specimens for testing, and begin to provide testing next week.”
In addition to diagnostic services provided through BioReference Laboratories, OPKO Health offers therapies for a variety of illnesses.
Somatrogon, a human growth hormone (hGH) therapy, has been evaluated in phase 3 clinical trials for the treatment of pediatric and adult growth hormone deficiency.
OPK88003, an analog of the peptide Oxyntomodulin which binds to the glucagon and GLP-1 receptors to regulate metabolism, is intended to treat diabetes and obesity.
Rayaldee (calciferol) is a therapy for secondary hyperparathyroidism (SHPT) in patients with vitamin D insufficiency and stage 3-4 chronic kidney disease (CKD) approved by the US Food and Drug Administration (FDA).