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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 16, 2019

Foundation Medicine to Seek FDA Approval for FoundationOne as CDx to Genentech's Rozlytrek

The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.

Aug 08, 2019

Guardant Health Preps Pan-Cancer FDA Bid, Highlights New MSI Validation Data

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The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.

Aug 02, 2019

Fulgent Gets NY State Clinical Lab Permit, Approval to Offer Genetic Tests

Temple City, California-based Fulgent offers genetic tests for a range of diseases and disorders, as well as custom panels and sequencing services.

Jul 31, 2019

Adaptive Bio Receives NY State Approval for ClonoSeq in B Cell Cancers

The regulatory approval means that the assay for minimal residual disease is available to monitor B cell blood cancers in patients in all 50 states.

Jul 18, 2019

FBI Opens Door for NGS-Based Forensics in US

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Verogen's ForenSeq kit and Thermo Fisher Scientific's Precision ID Whole Genome Panel can now be used to create DNA profiles for a national repository.

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.

Jul 09, 2019

FBI Approves Thermo Fisher NGS Forensic Profiling Solution

Forensic laboratories can now use the Applied Biosystems Precision ID System mtDNA analysis to submit profiles to a national database.

Jun 19, 2019

Japanese Regulators Approve Invivoscribe Assay as CDx for Daiichi Sankyo AML Drug

The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.

Jun 18, 2019

UK Request Pushes Illumina's Timeline for Completion of PacBio Acquisition to Q4

The UK Competition and Markets Authority has announced concerns that the $1.2 billion merger will reduce competition for Illumina and could scrutinize it further.

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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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