Lucira Health Celebrates Grand Opening of New Jabil Manufacturing Plant, Increasing Production of LUCIRA CHECK IT(TM) COVID-19 Self-Test
Lucira Health, Inc. (Nasdaq: LHDX), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, today announced the opening of a new production center in the Dominican Republic by its manufacturing partner Jabil Inc. (NYSE: JBL). The new facility will increase production of the LUCIRA CHECK IT(TM) COVID-19 test kit during the second quarter of 2021. Jabil also manufactures Lucira's unique COVID-19 test in Auburn Hills, Michigan.
Lucira CEO Erik Engelson and senior executives from Jabil's Healthcare and Dominican Republic Operations attended the ribbon cutting ceremony this Monday in the PIISA Industrial Park in Santa Cristobal, Dominican Republic. They met afterwards with President Luis Abinader and key government ministers.
"We started collaborating with Jabil before the pandemic after evaluating a number of highly regarded manufacturers," said Engelson. "What impressed us most was the quality of their work, experience in healthcare, and ability to scale quickly. We look forward to working closely with their supply and production teams so that our accurate, reliable COVID-19 test can help as many people as possible."
"We are thrilled to be working with Lucira Health at our newly opened site in the Dominican Republic," said David Panneton, vice president, Diagnostics, Jabil Healthcare. "Our operation has the ability to manufacture complex point-of-care / point-of-need molecular diagnostic devices to detect COVID-19 and other infectious diseases, all at large scale."
The LUCIRA CHECK IT(TM) COVID-19 test kit is available over the counter (OTC) in the United States. It is also the first self-test authorized by Health Canada for individuals with or without symptoms. Lucira's identical prescription test kit is the first U.S. FDA EUA-authorized, prescription, molecular diagnostic test for COVID-19 that can be self-administered by patients at home or used in a physician's office.
For users who need to share their test results, Lucira's free, text-based, easy-to-operate LUCI System can produce a LUCI PASS on a smartphone. It is being used to show a negative test result at entrances to conferences, arenas, and for travel and leisure.
Sensitive, accurate, easy to use
The LUCIRA CHECK IT(TM) COVID-19 test kit is designed to deliver polymerase chain reaction (PCR) quality molecular accuracy in 30 minutes or less at home, and is available online at lucirahealth.com for $55 U.S., excluding applicable taxes and delivery charges.
Each single-use test kit contains everything needed to conduct one COVID-19 test. It was designed and tested extensively for individuals to use independently and does not require a physician's prescription or telehealth or supervised assistance.
In clinical trials, Lucira's easy-to-use 'swab, stir and detect' CHECK IT test kit demonstrated that 100 percent of users successfully performed the test in less than two minutes. The current centralized laboratory testing environment currently takes two to fourteen days to generate similarly accurate test results.
Molecular tests are more sensitive than antigen tests because they amplify critical parts of the viral target. The targeted, molecular amplification that Lucira CHECK IT and PCR tests employ makes them demonstrably more sensitive and reliable than "rapid" antigen tests, which can miss active COVID-19 infections.
In a Community Trial setting, Lucira CHECK IT results were compared with the Hologic Panther Fusion, considered a high-sensitivity molecular test due to its low Limit of Detection (LOD). Lucira's accuracy was 98 percent, detecting 385 out of 394 positive and negative samples correctly when compared to the Hologic Panther Fusion, and excluding ten samples with very low levels of virus (those with very high PCR cycle thresholds of 37.5 or greater) that possibly no longer represented active infection. Comparative positive results agreed 97 percent of the time among this sample, and negative results agreed 98 percent of the time.
LUCIRA CHECK IT Test Kit
The LUCIRA(TM) CHECK IT test kit fits in the palm of a hand, extracts genetic material from the virus and amplifies it similar to PCR lab tests. Each Lucira test kit contains everything needed to run one COVID-19 test. Users get the test device, two AA batteries, sample vial, swab and simple instructions. The batteries are inserted in the device and the sample vial is placed in the test unit. The user then opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial, which is then gently pressed into the test unit to start the test. The "ready" light will blink until a "positive" or "negative" green light is illuminated within 30 minutes. For guidance on care and public health reporting, people can use Lucira's text based, secure LUCI portal to receive a result verification back on their phone while at the same time transmitting their result to the relevant public health authorities.
Lucira still has its identical, prescription product available for sale to healthcare providers at lucirahealth.com.
About Lucira Health, Inc.
Lucira is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits. Lucira's testing platform produces lab quality molecular testing in a single-use, consumer-friendly, palm size test kit powered by two AA batteries. Lucira designed its test kits to provide accurate, reliable and on-the-spot molecular test results anywhere and at any time. The LUCIRA CHECK IT (OTC) and LUCIRA COVID-19 All-In-One Test Kit (RX) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Lucira's testing program for select NBA fans. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "can" "plans," "will," "may," "anticipates," "expects," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Lucira's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Lucira's business in general and the other risks described in Lucira's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Lucira undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.