Research & Development
Lucira Health announces study results for chlamydia, gonorrhea assays on molecular POC platform
Lucira Health on Thursday announced results of a pilot study evaluating the performance of its combined chlamydia and gonorrhea molecular assays.
September 29, 2022
Abbott’s STI test gets FDA nod
The Alinity m STI test uses polymerase chain reaction (PCR) to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. The test requires one swab sample, or a urine sample collected in a healthcare setting, and it runs on Abbott's Alinity m molecular laboratory instrument.
May 3, 2022
Rheonix gets FDA nod for STI test, workstation
The Encompass MDx workstation enables scalable, multiplexed sample-to-answer detection, simplifying laboratory workflows.
January 11, 2022
BD Cor system features MX instrument for infectious diseases
The new instrument and its first test for sexually transmitted infections have received the CE Mark for IVD directive 98/79/EC.
December 16, 2021
USPSTF: Evidence weak for screening men for chlamydia, gonorrhea
The latest recommendations apply to asymptomatic, sexually active adolescents and adults, including those who are pregnant. The task force concluded with moderate certainty that there was a moderate net benefit to screen for chlamydia and gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. However, for men it did not issue a screening recommendation.
September 15, 2021
FDA clears Binx Health's chlamydia, gonorrhea POC assay
The FDA granted a waiver under the CLIA of 1988 allowing the assay to help with swift and appropriate treatment of sexually transmitted infections, Binx said.
April 1, 2021
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Quest Diagnostics completes acquisition of Summa Health outreach lab services business
New POC test performs well for chlamydia, gonorrhea in women
The multisite study evaluated tests for the two common sexually transmitted infections (STIs) on Binx Health's benchtop polymerase chain reaction (PCR) instrument, which delivers results in 30 minutes. The U.S. Food and Drug Administration (FDA) approved use of the instrument in men last month, following clearance for use in women in August 2019. Validation data supporting the regulatory clearances were published by Johns Hopkins epidemiologist Charlotte Gaydos and colleagues.
May 14, 2020
Binx point-of-care STI test cleared for men
The FDA previously cleared the company's rapid chlamydia and gonorrhea tests for women in 2019. The rapid test can provide results while patients are in the office and can help those with a positive STI test receive prompt treatment.
April 29, 2020
Applied BioCode respiratory panel gets U.S. OK
The nasopharyngeal swab test screens for common viruses and bacteria, including influenza A and B, respiratory syncytial virus, Chlamydia pneumoniae, and Bordetella pertussis. The company announced the U.S. filing in September, which was supported by a prospective, multilab study of more than 2,600 samples.
January 6, 2020
Applied BioCode files 510(k) for respiratory panel
The BioCode RPP works with the company's MDx-3000 molecular system. It tests swabs from the back of the nose and throat for 20 common viruses and bacteria, including influenza A, influenza B, respiratory syncytial virus (RSV), and Chlamydia pneumoniae. Up to 188 samples may be processed during an eight-hour shift, according to the company.
September 12, 2019
NeuMoDx launches 4 new CE-IVD tests
The assays work with the company's NeuMoDx 96 and NeuMoDx 288 molecular systems.
June 25, 2019
FDA clears 1st extragenital STD tests
The tests are designed to detect the presence of the bacteria Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) with extragenital specimens acquired via the throat and rectum. Previously, the tests were cleared only for use with urine, vaginal, and endocervical samples.
May 22, 2019
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