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
Talis Biomedical posts 600K in Q2 revenues
For the quarter (end-June 30), the Menlo Park, CA-based firm reported revenues of $600,000, up sixfold compared to revenues of $100,000 during the same period in 2021. During Q2, it booked $500,000 for product revenue driven by antigen testing sales, and the rest for grant revenue, the firm said.
August 2, 2022
Medline signs on as Visby distributor
A handheld PCR test with a CLIA waiver, the all-in-one unit can provide diagnostic test results in under 30 minutes for sexually transmitted infections in women, the firms said.
August 1, 2022
COVID-19 highlights need for at-home STI testing
It has been widely reported that the COVID-19 pandemic has caused declines in rates for different screening exams, and the same holds for STI screenings, according to the authors, led by Ellen Kersh, PhD, of the U.S. Centers for Disease Control and Prevention (CDC).
October 25, 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
Firm developing rapid gonorrhea test wins $19M prize
Visby Medical won the prize for its patient-side, disposable, molecular polymerase chain reaction (PCR) diagnostic device that detects Neisseria gonorrhoeae as well as markers of drug resistance. The device is a palm-sized, single-use, disposable device that detects N. gonorrhoeae and can determine whether the bacteria is susceptible to a single-dose antibiotic.
August 5, 2020
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
Binx point-of-care STI testing clears FDA
The polymerase chain reaction (PCR) product includes a benchtop instrument with a single-use, assay-specific cartridge. Vaginal swabs may be collected by patients in a clinical setting or by laboratorians, and results are available within half an hour, according to the company.
August 11, 2019
SpeeDx gonorrhea test gets breakthrough status in U.S.
ResistancePlus GC uses real-time quantitative polymerase chain reaction (qPCR) technology to test for gonorrhea and is already cleared for use in Europe, Australia, and Canada. The test detects the presence of N. gonorrhoeae bacteria, as well as sequences in the gyrA gene of the bacteria that could be a sign of an individual's susceptibility or resistance to treatment with the oral antibiotic ciprofloxacin.
June 10, 2019
FDA clears 2 Hologic tests for yeast infections
Hololgic's Aptima BV test is for bacterial vaginosis (BV), and the Aptima CV/TV assay is designed for detecting Candida vaginitis (CV) and Trichomomas vaginalis (TV). These three are the most common types of vaginitis, accounting for 90% of cases, and coinfection is common, the company noted.
May 28, 2019
Page 1 of 2