All posts by aclasuperadmin

ACLA Statement on FDA’s Revised Policy for Serologic Tests  

All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. –  Following the revised policy on serologic testing announced today by the Food and Drug Administration, ACLA President Julie Khani issued the following statement:

“ACLA is reviewing the latest announcement by the FDA. We commend the agency for its continued diligence in evaluating the available data regarding testing options and implementing policies that promote the public’s health. It is essential that patients and clinicians can depend on the accuracy and reliability of COVID-19 tests, and we look forward to continuing to work with the administration to expand the availability of high-quality tests nationwide.”

To read ACLA’s recent white paper, Supporting a Comprehensive, Nationwide Response to COVID-19: The Role of Serologic Testing, click here.

# # #

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

No stranger to serving communities ravaged by an epidemic, Tennessee-based Aegis Sciences sets its sights on a new challenge

All News

Every day, ACLA members are working around the clock to deliver accurate, reliable testing for communities across the country. Headquartered in Tennessee, Aegis Sciences Corporation, a leading health care company providing clinically innovative medication compliance testing and consulting services to providers, has joined the industry-wide effort to combat the COVID-19 pandemic.

Known for their leadership in the fight against the opioid epidemic, Aegis quickly expanded their nationwide testing efforts to include COVID-19 molecular testing at their biopharmaceutical labs.

“Our laboratory scientists are excited to be able to direct their experience and skills to serve in this new and vital manner which directly leverages Aegis’s expertise in high throughput testing,” said Dr. Matthew Hardison, SVP of Lab Operations at Aegis Sciences Corporation.

After receiving emergency use authorization from the FDA, Aegis began collecting and testing specimens from across the state on April 20. In just over a week, Aegis labs have quickly scaled capacity and are already performing thousands of tests per day. Aegis is now making additional investments to increase capacity to reach 7,000 tests performed per day within the next couple of weeks.

In a recent interview, Aegis CEO Frank Basile said Tennessee’s commitment to provide laboratories with the resources they need to perform COVID-19 tests has given labs the confidence to put forth the effort and the capital to expand state testing capacity. Experts say Tennessee’s model could be used to increase testing across the country.

Read more: Tennessee’s Secret To Plentiful Coronavirus Testing: Picking Up The Tab

Aegis has long supported communities across the country by providing the critical testing services necessary to adequately address their public health efforts. With their new COVID-19 testing capabilities, Aegis will build upon these partnerships to serve Department of Health offices and correctional facilities in its home state of Tennessee. Moreover, Aegis has already quickly expanded its COVID-19 testing to additional states, health systems and providers across the country. Notably, Aegis has expanded these efforts while still reliably serving communities with critical testing needed for the ongoing opioid epidemic.

With Aegis’ help, ACLA members have collectively performed more than 3.4 million tests for COVID-19 to date.

 

ACLA Statement on White House Meeting

Featured News, ACLA Press Releases

WASHINGTON, D.C. – Following today’s meeting at the White House, ACLA President Julie Khani issued the following statement:

“ACLA appreciated the opportunity to meet today with President Trump, Vice President Pence and other members of the White House Coronavirus Task Force. Representing the backbone of our nation’s testing response, ACLA members have now performed 3.2 million tests and remain focused on continuing to increase our COVID-19 testing capacity for both molecular and serologic tests.

In the meeting, ACLA communicated the importance of labs having the resources they need to perform high-throughput, accurate testing for patients. The administration has taken several important actions to support expanded testing capacity, including increasing the Medicare reimbursement rate for molecular tests, allowing laboratories to bring on additional testing platforms and increase testing for high-risk populations such as nursing home residents. The FDA also recently expanded the types of swabs that can be used for specimen collection, which is critical to reducing the bottlenecks that have limited COVID-19 testing.

Today, ACLA members stand ready to perform more testing and are working directly with governors to support state-led efforts across the country. To meet the goals put forth by our federal government, laboratories will need additional support. ACLA has urged HHS to allocate a portion of the $25 billion test fund to provide direct support to laboratories performing COVID-19 testing. In order to deliver accurate, reliable results for patients at a national scale, we must allocate funding to support their expanded efforts. We will continue to work closely with the administration and Congress to ensure that all laboratories performing high-quality COVID-19 testing have the necessary resources to expand testing capacity.”

# # #

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

In Tennessee and across the country, a calling to serve patients in need

Laboratory Professionals Week

This Laboratory Professionals Week, we’re taking a moment to thank laboratory researchers, technicians, administrative staff and medical officers who are going above and beyond the call of duty to serve patients during the COVID-19 pandemic. Today, ACLA is shining a light on Cyndi, a manager at Aegis Sciences who helped bring up new tests to meet the needs of patients in Tennessee. 

Cyndi is part of a team of dedicated laboratory scientists working diligently to expand COVID-19 testing capacity in labs all across the country.

“I would like to recognize Cyndi and the rest of our hard working BioPharma laboratory team,” said Dr. Matthew Hardison, SVP of Lab Operations at Aegis. “Cyndi and her team worked quickly to leverage Aegis’s molecular testing capabilities to offer testing for COVID-19. This testing is vital to better understand the impact of SARS-CoV-2 and helps to reduce the spread of the virus.”

Every single day, lab professionals like Cyndi are working around the clock to bring vital testing capacity to the patients who need it most. To date, ACLA members have performed more than 2.88 million tests for COVID-19.

Adapting platforms with ingenuity, determination and hard work

Laboratory Professionals Week, All News

This Laboratory Professionals Week, we’re taking a moment to thank laboratory researchers, technicians, administrative staff and medical officers who are going above and beyond the call of duty to serve patients during the COVID-19 pandemic. Today, ACLA is shining a light on Exact Sciences in Madison, Wisconsin, where dedicated lab professionals worked around the clock to adapt their colorectal cancer screening platform for COVID-19 testing. 

Exact Sciences teams adapt colorectal cancer screening platforms for COVID-19 testing

At Exact Sciences in Madison, Wisconsin, teams are working around the clock to support testing for COVID-19. Over the last several weeks, dedicated lab professionals have worked tirelessly to adapt the company’s flexible, automated lab platform, which normally looks for biomarkers associated with colorectal cancer, to now look for COVID-19.

“Work that would normally take months is now being accomplished in weeks,” says Ana Hooker, Exact Sciences’ Senior Vice President of Operations. “It’s inspiring to see our laboratory professionals take on this public health challenge with optimism and determination, while at the same time continuing to deliver Cologuard and Oncotype DX results to providers and patients.”

Thanks to the efforts of these dedicated lab technicians and staff, Exact Sciences has been able to continue to support cancer screening while also providing COVID-19 testing.

“Everyone at Exact Sciences wants to do our part, and we thank all our colleagues for doing theirs,” says Hooker. “Together, we will overcome this pandemic and demonstrate the amazing ingenuity and talents of the people working in our industry.”

ACLA members, including Exact Sciences, have collectively performed 2.7 million tests for COVID-19 and continue to expand capacity nationwide. 

 

On a mission to expand access to accurate, reliable COVID-19 testing

Laboratory Professionals Week

This Laboratory Professionals Week, we’re taking a moment to thank laboratory researchers, technicians, administrative staff and medical officers who are going above and beyond the call of duty to serve patients during the COVID-19 pandemic. Today, ACLA is featuring BioReference’s Chief Medical Officer and laboratory director who has played a critical role expanding public access to accurate, rapid COVID-19 testing nationwide. 

A Trailblazing Chief Medical Officer 

James Weisberger, M.D., Chief Medical Officer of BioReference Laboratories

James [Jim] Weisberger, M.D., chief medical officer and laboratory director for BioReference Laboratories, is a board certified anatomic and clinical pathologist and has proven to be a trailblazer during this pandemic. Through resourceful innovation and guidance, Dr. Weisberger has demonstrated an unwavering commitment to expand public access to laboratory testing of COVID-19, specifically to critical patients, by ensuring they receive results in 24 hours or less. Under his leadership, the laboratory has processed and shared the results of more than 300,000 tests. 

Dr. Weisberger dedicates many hours each day to safeguard key laboratory operations and quality systems. He has identified out of the box solutions to increase capacity, maintain turnaround times and leverage all resources to accelerate the COVID-19 diagnostic response. What’s more, he also ensures that patients receive their results to help guide treatment. 

“Providing patients accurate COVID-19 results as quickly as possible is our duty as a laboratory,” said Dr. Weisberger when asked about his role during this unrelenting health crisis. “The ability to utilize emerging technology and provide further answers to health care providers and their patients is how we can limit the spread of the virus.”

During Laboratory Professionals Week, many laboratory professionals are recognized for their contributions and join dedicated health care providers, first-line responders, policy-makers and members of the administration who are combating the COVID-19 pandemic. 

Thanks to dedicated lab professionals, like Dr. Weisberger, commercial labs across the nation have performed more than 2.7 million COVID-19 tests to date.

An unwavering commitment to serve vulnerable communities

Laboratory Professionals Week

This Laboratory Professionals Week, we’re taking a moment to thank laboratory researchers, technicians, administrative staff and medical officers who are going above and beyond the call of duty to serve patients during the COVID-19 pandemic. Today, ACLA recognizes Maryann O’Toole, Acting Vice President of Operations of WestPac Labs, a Sonic Healthcare USA clinical laboratory in Santa Fe Springs, California. Every day, O’Toole and her team are working around the clock to serve the country’s most vulnerable patients, including nursing home residents and the homeless.

WestPac Labs employees Norinne (left) and Natalie (right) hard at  work reviewing results and receiving SARS-CoV-2 specimens.

Over the past few weeks, Sonic Healthcare USA swiftly brought on additional testing platforms to meet the testing demands of vulnerable patient populations, like nursing home residents, the homeless and inmates. Medical and operational teams at WestPac Labs—a Sonic Healthcare USA clinical laboratory in Santa Fe Springs, CA—have been working tirelessly to support local governments, nursing homes, first responders and underserved populations by providing on-site resources and meeting logistical needs.

Acting Vice President of Operations Maryann O’Toole, reaching out to the community of Los Angeles to provide SARS-CoV-2 testing.

Maryann O’Toole, Acting Vice President of Operations of WestPac Labs, recently assisted the Union Rescue Mission in Los Angeles by working on-site alongside physicians to handle and transport specimens and deliver test results.

“I truly believe that as medical laboratory professionals, it is our responsibility to be ambassadors to all patients in need, she said. “We are not just known as a testing laboratory, but have become true partners and colleagues to our hospitals, communities, nursing homes, senior living facilities and our homeless populations.”

At the same time, O’Toole is leading and coordinating Sonic Healthcare USA’s national testing response for the nursing home population across all of their clinical laboratories. Through her unwavering commitment to quality patient care, O’Toole exemplifies the profound responsibility and dedication of a medical laboratory professional.

Thanks to the hard work and commitment of these lab professionals, Sonic Healthcare USA and their fellow ACLA members have performed more than 2.6 million COVID-19 tests to date.

 

Working non-stop to deliver the results patients need

Laboratory Professionals Week

This Laboratory Professionals Week, we’re taking a moment to thank laboratory researchers, technicians, administrative staff and medical officers who are going above and beyond the call of duty to serve patients during the COVID-19 pandemic. Today, ACLA is shining a light on Quest’s “COVID Standouts” at their Chantilly, VA Molecular Infectious Disease Lab and their Schaumburg, Illinois lab. These employees’ hard work behind the scenes validating tests, supporting clients and preparing incoming COVID-19 specimens has been essential to Quest’s testing efforts. 

 

Behind the Scenes in Chantilly, Virginia: Megan, Cary, Tamara 

Lab professionals are working around the clock all across the country to help stop the spread of COVID-19. While some heroes wear lab coats, others work behind the scenes. In Quest’s Molecular Infectious Disease lab in Chantilly, Virginia, the team is working day in and day out to deliver COVID-19 results. 

“It feels good to help with a bigger cause,” says Tamara, a Specimen Management Laboratory Admin.

On March 27, Chantilly banded together by wearing red to unify in the fight against COVID-19. Why red? On Fridays, employees wear red wristbands after they’ve had their temperature screened upon their entrance into the building. Each day, employees receive a different color wristband after having their temperature screened.

Megan, a Client Service Representative, working to ensure COVID-19 clients are more than satisfied.
Cary, Specimen Management Specimen Technician II, sorting frozen incoming COVID-19 samples.
Tamara, a Specimen Management Laboratory Admin.

 

 

 

 

 

 

Delivering Results in Schaumburg, Illinois: Dhartika, Jacqueline and Sangeeta 

Dhartika (left), Jacqueline (center) Sangeeta (right) in Quest’s Schaumburg, Illinois lab are getting the job done.

Just like their Chantilly, VA colleagues, Quest’s team in Schaumburg, Illinois is working nonstop to perform testing for COVID-19.

Testing starts with validating the assay to make sure all the equipment is working properly. Each employee prepares the specimen to put in the Roche P6800, which is featured in the background of this photo. Once the specimen is processed, they are able to report out the results.

Thanks to Quest’s employees – in VA, IL and around the country – and the hard work of their fellow lab professionals, commercial labs across the nation have conducted more than 2.6 million COVID-19 tests to date.