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Ortho Clinical Diagnostics, Hangzhou AllTest Biotech, Others Obtain FDA Clearances in January

Ortho got the green light for a reagent pack used to measure creatine kinase myocardial band on the firm's Vitros 3600 Immunodiagnostic System.

In Brief This Week: 23andMe, PerkinElmer, SQI Diagnostics, and More

News items for the in vitro diagnostics industry for the week of May 24, 2021.

23andMe Begins Reporting PGx Variants With Drug Info Under Recent FDA Clearance
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The new reports link variants in CYP2C19 to the safety and efficacy of two drugs, a commonly prescribed antiplatelet drug and an antidepressant.

OncoCyte Posts $555K in Q3 Revenues, Net Loss Rises

The company beat the consensus Wall Street estimate on the top line but narrowly missed it on the bottom line. 

Ancestry, 23andMe, DiaSorin, Adaptive Biotechnologies, Others Receive FDA Clearances in August

The FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.

Aug 28, 2020

Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs

Aug 18, 2020

23andMe Garners FDA Clearance for CYP2C19 PGx Test Report

Apr 23, 2020

Finland's Negen Introduces Pharmacogenomics Panel for COVID-19 Therapies

Jan 31, 2020

Translational Software to Submit PGx Software Platform for 510(k) Clearance
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Jul 16, 2019

Alnylam, 23andMe Partner on Free Family Testing Program for Hereditary ATTR Amyloidosis

Apr 5, 2019

23andMe DTC Breast, Ovarian Cancer Risk Test Misses Almost 90 Percent of BRCA Mutation Carriers

Mar 22, 2019

Confirmatory Testing, Insurance Coverage Growing Alongside DTC Genetic Testing
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Feb 8, 2019

Sysmex, Beckman Coulter, Thermo Fisher Scientific, Others Receive FDA Clearances in January

Feb 6, 2019

OraSure Technologies Q4 Revenues Down 3 Percent

Jan 22, 2019

23andMe Gets FDA Approval for Genetic Risk Report on Hereditary Colorectal Cancer Syndrome

Nov 6, 2018

Myriad Q1 Revenues Up 13 Percent

Nov 5, 2018

FDA Actions on PGx Testing Confuse Genetic Industry Players
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Oct 31, 2018

23andMe Gains FDA Market Authorization to Sell PGx Test Reports Directly to Consumers

May 30, 2018

Stakeholders Urge Payors to Cover Confirmatory Testing for 23andMe's DTC BRCA Test
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Mar 12, 2018

BRCA Screening Study Uses Consumer Initiated Model to Enroll Thousands in Ashkenazi Jewish Community
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Mar 7, 2018

Oncology Community Sees Potential for Patient Harm in FDA OK of 23andMe BRCA Test
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Mar 6, 2018

FDA Authorizes 23andMe DTC Test Report for Three BRCA Mutations

Nov 6, 2017

FDA Eases Regulatory Path, Consumer Access to Genetic Health Risk Tests

Oct 25, 2017

LabCorp Q3 Revenues Rise 10 Percent, Driven by Acquisitions

Sep 28, 2017

Multigene Risk Test Takes Aim at Preclinical Alzheimer’s Dementia
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