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regulatory approval

Guardant Health Receives New York State Approval for Guardant Reveal MRD Test

The assay is Guardant Health’s first commercially available product for clinical management of early-stage tumors and is initially focused on colorectal cancer.

Delfi Diagnostics Starts Prospective Lung Cancer Screening Trial

The company is planning to commercialize its cancer early detection technology initially in lung cancer and is working with NYU researchers to explore future expansions.

Binx Health Chlamydia and Gonorrhea Test CLIA Waived

The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver.

Illumina Receives Medical Device Registration in Russia for NextSeq 550 Dx Sequencer, Reagents

R-Pharm, Illumina's strategic partner in Russia and the Commonwealth of Independent States (CIS), led the registration process with the Russian regulatory agency.

OpGen Unyvero IVD Platform Nabs Chinese Regulatory Approval

The company's cartridge for pneumonia for the Unyvero system is under review and pending approval by Chinese regulators.

Feb 25, 2021

Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch
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Jan 19, 2021

MiRxes Receives CE Mark, Singapore Regulatory Approval for Multiplex SARS-CoV-2, Flu Test

Dec 2, 2020

China NMPA Approves Illumina NextSeq 550Dx Sequencer for Genetic Testing and Diagnosis

Nov 13, 2020

FDA Approves Merck's Keytruda, Agilent CDx in PD-L1-High Triple-Negative Breast Cancer

Nov 11, 2020

OpGen Posts 70 Percent Increase in Q3 Revenues Amid Shuffling of Portfolio

Nov 9, 2020

FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Lynparza

Oct 29, 2020

Roche EGFR Mutation Test Approved by FDA as Companion Diagnostic for NSCLC

Oct 27, 2020

FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Three Targeted Therapies

Oct 26, 2020

FDA Approves Foundation Medicine CDx, Bayer's Vitrakvi for NTRK Patients

Sep 8, 2020

FDA Approves Thermo Fisher Scientific CDx for Genentech's Gavreto in NSCLC Patients With RET Fusions

Aug 31, 2020

T2 Biosystems Gets FDA EUA for SARS-CoV-2 Molecular Diagnostic Test

Aug 27, 2020

Amoy Diagnostics, Haihe Pharmaceutical Ink Agreement to Codevelop CDx for Lung Cancer Treatment

Aug 27, 2020

Foundation Medicine Liquid Biopsy Gets FDA Approval for Multiple Companion Diagnostic Indications

Aug 7, 2020

Guardant Health CDx Wins FDA Approval for First Liquid Biopsy NGS Tumor Profiling Assay

Jul 22, 2020

Devyser Gains CE Mark for NGS Hereditary Breast and Ovarian Cancer Test

Jul 13, 2020

Vela Diagnostics Automated Coronavirus Test Gets CE-IVD Mark

Jun 18, 2020

Promega Maintains Microsatellite Instability IVD Plans Amid Evolving Cancer Test Landscape
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Jun 17, 2020

FDA Approves Merck's Keytruda, Foundation Medicine CDx for TMB-High Solid Tumors

Jun 10, 2020

Sysmex Obtains Japan Marketing Approval for Use of Saliva With Coronavirus Kit

May 28, 2020

Quest Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Self-Collection Test Kit

Breaking News
The Scan

Another Resignation

According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug.

Novavax Finds Its Vaccine Effective

Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19.

Can't Be Used

The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports.

PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More

In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.