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Jul 11, 2019

Enzo Biochem Gets NY Approval for Oral, Rectal CT/NG Test; Updates Lab Business Models

The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.

May 24, 2019

Startup Novel Microdevices Developing Rapid Point-of-Care MDx System for STIs

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The company received support from a Johns Hopkins University center focused on point-of-care device development for sexually transmitted infections.

May 23, 2019

FDA Clears Cepheid, Hologic CT/NG Assays for Extragenital Testing

The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.

May 15, 2019

Binx Health Targeting Broader STI Screening With Rapid POC Platform

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The firm is developing a multipanel test and an antibiotic resistance panel to augment its recently CE marked chlamydia and gonorrhea assay.

May 01, 2019

Binx Health Gets CE Mark for Chlamydia, Gonorrhea Point-of-Care Test

The firm said that its point-of-care test delivers laboratory-quality results in about 30 minutes and could be used in the home and other settings.

Mar 19, 2019

Abbott Receives CE Mark for Alinity Molecular Diagnostics System, Assays

Abbott said that the MDx platform offers a number of initial assays, including tests for HIV-1, HBV, and HCV, among others.

Mar 18, 2019

SpeeDx Signs Distributor Deals in Middle East

The deal will enable the Australian firm to distribute its diagnostic tests in the United Arab Emirates, Saudi Arabia, Bahrain, Qatar, and Oman.

Dec 06, 2018

SpeeDx Gets CE-IVD Mark for Antibiotic-Resistant Gonorrhea MDx

The firm said that the Resistance GC assay will allow doctors to treat up to 70 percent of infected patients with a single dose of ciprofloxacin.

Nov 19, 2018

Sexually Transmitted Infectious Disease Dx Testing Gains Traction in Clinics, at Point of Care

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Developers of POC STI platforms and assays said that the tests provide convenience, privacy, and quick results in an area of testing in need of these benefits.

Nov 13, 2018

Point-of-Care Molecular Diagnostic Platform That Skips Need for Amplification Being Developed at UCLA

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The nucleic acid diagnostic platform they are developing doesn't require expensive optics, and it could be available as a manufacturing prototype in about a year.

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