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Visby Medical Anticipates Rapid Uptake of Handheld PCR Test for STIs
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The firm received clearance and CLIA waiver for a 30-minute point-of-care PCR assay for three common STIs earlier this week.

Visby Medical Obtains FDA 510(k), CLIA Waiver for Multiplex STI Test Using Handheld PCR Device

The CLIA waiver enables clinicians to run a 30-minute multiplex test for chlamydia, gonorrhea, and trichomonas during a patient's visit.

JHU Researchers Develop 15-Minute PCR System, Drug-Resistant Gonorrhea Test
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The Hopkins team expects to spinout a company soon in order to commercialize the technology in the next two to three years.

CLIA Waiver in Hand, Binx Health Targeting Retailers, Urgent Care Centers With STI Tests
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Binx Health said that when it received FDA CLIA waiver, it already had a strategic partner for sales of its POC platform and chlamydia and gonorrhea tests.

CARB-X Commits up to $13.8M to Novel Microdevices for Point-of-Care STI Test

Novel Microdevices is developing a portable, sample-to-answer instrument that is designed to perform molecular testing on untreated patient samples.

Mar 30, 2021

Binx Health Chlamydia and Gonorrhea Test CLIA Waived

Sep 9, 2020

Visby Medical Takes on STI, COVID-19 Testing With Single-Use PCR Machine
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Aug 5, 2020

Visby Medical Gonorrhea Test Wins $19M AMR Diagnostic Competition

Jun 16, 2020

Roche, SpeeDx Partner to Expand Access to Antibiotic Resistance Tests

Apr 30, 2020

FDA Provides Second Clearance for Binx MDx Platform

Feb 11, 2020

New York State Approves Enzo Biochem STI Tests on GenFlex Platform

Nov 19, 2019

Rheonix Submits MDx System, Triplex Sexually Transmitted Infections Test to FDA

Nov 7, 2019

SpeeDx, QuantuMDx Collaborate with FIND on POC Molecular Diagnostics for STIs

Nov 4, 2019

Shield Bio Brings Nanopore Sequencing to Patients Through STI Test Service
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Oct 15, 2019

Enzo Biochem Fiscal Q4 Revenues Down 8 Percent

Sep 6, 2019

As M. Genitalium, Gonorrhea Molecular Testing Expands, Antibiotic Resistance Assays May Follow
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Aug 27, 2019

After Years of Groundwork, Rapid STI MDx Space is Inaugurated With Binx FDA Clearance
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Aug 12, 2019

FDA Clears Binx Health Point-of-Care Testing Platform for Chlamydia, Gonorrhea

Aug 5, 2019

SpeeDx Raises $15M in Equity Investment

Jul 11, 2019

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

May 24, 2019

Startup Novel Microdevices Developing Rapid Point-of-Care MDx System for STIs
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May 23, 2019

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

May 15, 2019

Binx Health Targeting Broader STI Screening With Rapid POC Platform
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May 1, 2019

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

Mar 19, 2019

Abbott Receives CE Mark for Alinity Molecular Diagnostics System, Assays

Breaking News
The Scan

Not Yet a Permanent One

NPR says the lack of a permanent Food and Drug Administration commissioner has "flummoxed" public health officials.

Unfair Targeting

Technology Review writes that a new report says the US has been unfairly targeting Chinese and Chinese-American individuals in economic espionage cases.

Limited Rapid Testing

The New York Times wonders why rapid tests for COVID-19 are not widely available in the US.

Genome Research Papers on IPAFinder, Structural Variant Expression Effects, Single-Cell RNA-Seq Markers

In Genome Research this week: IPAFinder method to detect intronic polyadenylation, influence of structural variants on gene expression, and more.