Kroger Health Receives FDA Emergency Use Authorization for its COVID-19 Test Home Collection Kit

Rhea-AI Summary

Kroger Health has received FDA Emergency Use Authorization for its COVID-19 Test Home Collection Kit, enabling at-home sample collection supported by telehealth consultations. This initiative will initially serve frontline associates and aims to process up to 60,000 tests weekly by the end of July. The kit includes necessary materials for sample collection and guarantees privacy for test results. Kroger Health plans to expand availability across various states, addressing accessibility issues for individuals without transportation. This effort is part of Kroger's commitment to public health during the pandemic.

Positive

• FDA granted Emergency Use Authorization for COVID-19 Test Home Collection Kit.
• Aims to process up to 60,000 tests weekly by the end of July.
• Initial availability for frontline associates with plans to expand to other organizations.
• Addresses access issues for individuals lacking transportation to testing sites.

Negative

• None.

CINCINNATI, July 1, 2020 /PRNewswire/ -- Kroger Health, the healthcare division of The Kroger Co. (NYSE: KR), today announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization for the COVID-19 Test Home Collection Kit. The testing solution combines the safety and convenience of at-home sample collection with the expert guidance of a telehealth consultation to help improve the quality of the collection process.

Kroger Health's COVID-19 Test Home Collection Kit will be available to frontline associates across Kroger's Family of Companies, based on medical need, beginning this week. In partnership with Gravity Diagnostics, a full-service clinical laboratory located in Covington, KY, Kroger Health plans to rapidly expand the availability of the home collection kits to other companies and organizations in the coming weeks, with a goal of processing up to 60,000 tests per week by the end of July.

"Throughout the COVID-19 pandemic, the safety of our associates and our customers has remained our top priority," said Colleen Lindholz, president of Kroger Health. "Kroger Heath remains committed to helping people live healthier lives through our multi-disciplinary team of licensed, trained and experienced healthcare providers. Over the past few months, Kroger Health has been providing Americans with access to COVID-19 testing through community test sites across the country; however, we've observed some individuals do not have access to transportation or live near these community testing locations. To help ease this burden and provide greater accessibility, we will be offering a home testing solution to our associates first followed by other companies and organizations."

Kroger Health's COVID-19 Test Home Collection Kit: How it Works

• The home collection is performed under the supervision of a licensed healthcare professional. The process is simple and is available at no cost to eligible patients who meet established clinical criteria for likely COVID-19 infection or exposure.
  
  
• Patients will be provided access to a website where they will answer screening questions, input their organization's benefit code and an individual code, like an employee ID, and complete a clinical assessment. If a patient qualifies, a healthcare professional will issue a prescription and the home collection kit is shipped to their home within 24-48 hours.
  
  
• The home collection kit includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory.
  
  
• Upon receipt of the home collection kit, a healthcare professional guides the home collection process via telehealth – a two-way video chat. The direct observation helps to ensure the proper technique is used for sample collection.
  
  
• The patient will then overnight ship their sample to the laboratory for processing, which on average will take 24-48 hours.
  
  
• At the laboratory, the collection undergoes a molecular diagnostic test – a test which detects parts of the SARS-CoV-2 virus and can be used to diagnose active infection with the SARS-CoV-2 virus.
  
  
• If test results are negative for an active infection, results are released to the patient's electronic medical record portal. Alternatively, patients may be called if they do not consent to use of the portal. For a patient whose test result is positive, a healthcare professional will contact them via phone to provide a recommended course of care.
  
  
• Test results will only be accessible to the patient and only shared with their organization if the patient authorizes the release of his or her results. All results are reported to government health agencies as required by law.

"As our country experiences an increase in COVID-19 cases, physical distancing, wearing protective masks and testing remains paramount to flattening the curve," said Jim Kirby, senior director of Kroger Health. "We know flexible, accessible testing options like home solutions that leverage telehealth technology are critical to accelerating America's reopening and recovery."

The Kroger Health COVID-19 Test Home Collection Kit will initially be available in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Michigan, Montana, Nevada, New Mexico, Ohio, Tennessee, Utah and Virginia. Additional states will be added in the coming weeks.

Kroger Health launched public drive-thru and walk-up COVID-19 testing sites in April. Since then, Kroger Health has administered more than 100,000 tests across 19 states.

To download images of the Kroger Health COVID-19 Test Home Collection Kit, please visit here.

About Gravity Diagnostics:
Gravity Diagnostics is a full-service state-of-the-art CLIA laboratory licensed in all 50 states providing innovative laboratory testing including Infectious Disease (Upper Respiratory and Sexually Transmitted), Toxicology, and Pharmacogenomics. We are an advocate for physicians, patients, and our communities, supporting them with unsurpassed integrity, regulatory compliance, and clinical expertise. Learn more by visiting gravitydiagnostics.com.

About Kroger Health:
Kroger Health, the healthcare division of The Kroger Co., is one of America's leading retail healthcare organizations, with over 2,000 pharmacies and 200 clinics in 35 states serving more than 14 million customers. Our team of 22,000 healthcare practitioners - from pharmacists and nurse practitioners, to dietitians and technicians – are committed to helping people live healthier lives. We believe in practicing at the top of our licenses and enabling "food as medicine" to help prevent or manage certain diseases. Learn more at -1%26h%3D3033973941%26u%3Dhttp%253A%252F%252Fwww.krogerhealth.com%252F%26a%3Dwww.krogerhealth.com&a=www.krogerhealth.com" rel="nofollow">www.krogerhealth.com.

About The Kroger Co.:
At The Kroger Co. (NYSE: KR), we are Fresh for Everyone™ and dedicated to our Purpose: To Feed the Human Spirit®. We are, across our family of companies, nearly half a million associates who serve over 11 million customers daily through a seamless shopping experience under a variety of banner names. We are committed to creating #ZeroHungerZeroWaste communities by 2025. To learn more about us, visit our newsroom and investor relations site.

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SOURCE The Kroger Co.

FAQ

What is the Kroger COVID-19 Test Home Collection Kit?

The Kroger COVID-19 Test Home Collection Kit allows individuals to collect samples at home with telehealth support.

When was the Kroger COVID-19 Test Home Collection Kit authorized?

The FDA granted Emergency Use Authorization for the kit on July 1, 2020.

How many tests can Kroger process with the new COVID-19 kit?

Kroger aims to process up to 60,000 tests per week by the end of July.

Who is the initial target for the Kroger COVID-19 test kit?

The initial target includes frontline associates across Kroger's Family of Companies.

In which states will the Kroger COVID-19 Test Home Collection Kit be available?

The kit will initially be available in states like Arizona, Colorado, Georgia, Indiana, and several others.