Lucira Health Reports Pilot Study Interim Results for Chlamydia and Gonorrhea Assays
09/29/2022 - 07:00 AM
Study Reveals Lucira’s Testing Assays Offer a 98% Accuracy Rate in Detecting Both Sexually Transmitted Infections
EMERYVILLE, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Lucira Health, Inc. (Nasdaq: LHDX) (“Lucira Health” or “Lucira”), a medical technology company, today announced interim results of a pilot study to evaluate the performance of their combined Chlamydia trachomatis and Neisseria gonorrhoeae assays integrated into the instrument-free at-home Lucira molecular test platform. The development of these assays is supported by several grants from the National Institutes of Health with Prof. Deborah Dean, MD, MPH, at UC San Francisco. This current study follows a previously published study of over 350 clinical samples where the Lucira Chlamydia assay chemistry demonstrated a performance of 94% sensitivity and 99% specificity, with an overall accuracy of 98% 1 . The ongoing study has tested over 150 female participants with positive performance results of the integrated chlamydia and gonorrhea tests and will be published in the near future.
“We developed a rapid point of care test (POCT) which uses Lucira Health’s loop-mediated amplification (LAMP) of nucleic acids, and performed a double blind, head-to-head comparison with the Cepheid Xpert® CT/NG assay using clinician-collected de-identified paired vaginal samples. These samples were collected from symptomatic and asymptomatic females aged 18 years and older who were attending the Ministry of Health and Medical Services Health Centers in Fiji,” said Dr. Dean. “With a 30-minute swab-to-result time and 98% accuracy, our POCT is a game changer for improving clinical practice to prevent and control both Chlamydia trachomatis and Neisseria gonorrhoeae sexually transmitted infections (STIs) in diverse health care settings globally. With the hand-held device already widely accepted by the consuming public, we anticipate an increase in widespread use inside clinics and at home.”
Lucira is integrating these STI assays into its easy-to-use fully untethered test platform that requires no external equipment and produces rapid molecular results on-the-spot.
“It’s an honor to have world renowned principal investigator, Deborah Dean, MD, MPH, leading the clinical trials for Lucira’s chlamydia and gonorrhea assays,” said Debkishore Mitra, Ph.D, Chief Technology Officer and Co-Founder at Lucira Health. “With STI numbers growing globally each year, Lucira’s vision is to build these new assays into our existing lab-quality tests to be used at home and empower both consumers and clinicians with a collaborative, easy approach to getting more accurate and faster results. The level of accuracy achieved in these results continues to show this technology platform can bring world-class diagnostics that are faster, easier, and more flexible to help in this mission of healing.”
Chlamydia and gonorrhea infections total over 2.2 million cases annually in the United States, have been increasing each year, and represent a larger burden globally, according to the CDC. The majority of female infections are asymptomatic and, as a result, the U.S. Preventative Services Task Force recommends annual screening of sexually active women 25 years of age or younger. This translates into potentially 20 million screening tests per year, a significant opportunity to support surveillance testing both in point of care and home testing.
About Lucira Health www.lucirahealth.com .
Forward Looking Statements Chlamydia trachomatis and Neisseria gonorrhoeae sexually transmitted infection in diverse health care settings globally; the increase in widespread use of our POCT inside clinics and at home; the growth of STI numbers globally each year; and the number of potential screening tests of Chlamydia and gonorrhea infections per year. These forward-looking statements are based upon our 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, including our ability to increase production, streamline operations and increase product availability; our ability to obtain and maintain regulatory approval for our tests; the size and growth potential of the markets for our tests and our ability to serve those markets; the expected future growth of our sales and marketing organization; our expectations around the timing of submission and receipt of regulatory approval for our tests; the performance of, and our reliance on, third parties in connection with the commercialization of our tests; our research and development for any future tests; the development, regulatory approval, and commercialization of competing products; our ability to retain and hire senior management and key personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; our expectations regarding our ability to obtain and maintain intellectual property protection for our tests, as well as our ability to operate our business without infringing the intellectual property rights of others; our ability to navigate unfavorable global economic conditions that may result from recent geopolitical events, including the COVID-19 pandemic, Russia’s military intervention in Ukraine, and the global sanctions imposed by countries against Russia that followed; our ability to successfully continue to expand internationally; any impact on our ability to market our tests; demand for our tests due to deferral of procedures using our tests or disruption in our supply chain; our ability to achieve or sustain profitability; our ability to gain market acceptance for our tests and to accurately forecast and meet customer demand; our ability to compete successfully; our ability to enhance and expand our product offerings; our ability to accurately predict continued expansion; our ability to accurately forecast revenue; development and manufacturing problems; capacity constraints or delays in production of our tests; maintenance of coverage and adequate reimbursement for procedures using our tests; and test defects or failures. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and subsequently filed reports. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and we assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.
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1 Dean, Deborah, et al. "Development and evaluation of a point-of-care test in a low-resource setting with high rates of Chlamydia trachomatis urogenital infections in Fiji." Journal of clinical microbiology 59.7 (2021): e00182-21.
