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Oct 02, 2019

Cepheid Xpert BCR-ABL Ultra Leukemia Monitoring Test Gets FDA Clearance

The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said. 

Oct 01, 2019

FDA Clears Luminex Aries MRSA Assay

The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.

Sep 23, 2019

FDA Expands Approval of Exact Sciences Colorectal Cancer Test to Younger People

The agency has approved the use of Exact's Cologuard test for average-risk individuals aged 45 and older.

Sep 20, 2019

Roche Gains FDA Clearance for Cobas Babesia Blood Test

The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions. 

Aug 27, 2019

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

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The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.

Jun 28, 2019

Akonni Biosystems Developing Multi-Target Infectious Diseases Tests for Newly Cleared TruDx System

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The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.

Jun 12, 2019

FDA Clears Roche Extraction Platform For Use With Applied BioCode GI Pathogen Panel, System

Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.

May 30, 2019

FDA Clears DiaSorin Molecular Meningitis, Encephalitis Assay

The assay is for detecting varicella-zoster virus in cerebrospinal fluid and can be used with the firm's Liaison MDx instrument.

May 29, 2019

FDA Clears Two Hologic Vaginitis Assays

The Aptima BV test detects bacterial vaginosis and the Aptima CV/TV detects and differentiates candida infections from trichomonas.

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.

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The Scan

Genome of an Oak

A new study catalogues the genome and evolutionary history of the oak family, UPI reports.

'Mostly Chihuahua, or Mostly Rat Terrier'

Dog DNA testing is a growing market, but there's still a lot of uncertainty about the accuracy of the results, the Boston Globe says.

Amelia, Is That You?

A University of South Florida researcher is testing bone fragments to determine if they belong to Amelia Earhart.

Cell Papers Explore Koala Genome Retrovirus Responses, Liver Cancer Proteomics, More

In Cell this week: antisense Piwi-interacting RNA responses to endogenous retroviruses, proteomic patterns in hepatocellular carcinoma, and more.

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