In Vitro Diagnostics News and Research

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FDA permits marketing of Dexcom G6 integrated continuous glucose monitoring system

The U.S. Food and Drug Administration today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes.

28 Mar 2018

Vitl Life Science Solutions announces launch of new Lu-mini at analytica 2018

Vitl Life Science Solutions, a member of the ITL Group, announce the highly-anticipated launch of the Lu-mini – a new product set to revolutionize the market for low-cost OEM benchtop luminometers.

19 Mar 2018

Technological advances in biosensors could reduce spread of HIV infection

1.8 million people acquire HIV each year, with the World Health Organisation estimating that 1 in 5 people living with HIV do not realize they are infected. Therefore, strategies for faster and earlier diagnosis are as important as ever to limit the spread of HIV.

From IDTechEx Ltd 7 Mar 2018

GlobalData reveals increasing demand for IVD testing as focus on personalized medicine becomes the norm

The in vitro diagnostic testing market is one of the fastest-growing segments within the medtech industry.

12 Feb 2018

Eagle Biosciences launches novel Intact FGF23 ELISA Assay Kit

Eagle Biosciences, Inc. is proud to announce the launch of a new assay, MedFrontier FGF23 (Human Intact FGF23) ELISA Assay Kit. This assay was developed and manufactured by Kyowa Medex Co., Ltd from Tokyo, Japan.

27 Jan 2018

Study tests accuracy of laboratory-developed cancer tests and FDA-approved companion diagnostics

Cancer molecular testing can drive clinical decision making and help a clinician determine if a patient is a good candidate for a targeted therapeutic drug.

14 Dec 2017

FDA grants clearance to new blood cell count test that allows faster availability of results

The U.S. Food and Drug Administration today cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians' offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for faster availability of results.

6 Nov 2017

Report sheds light on global market for infectious disease immunoassays

Kalorama Information says that infectious disease immunoassays beat the IVD market and the overall IVD market in terms of revenue growth. Immunoassays are tests that are based on the binding of antibodies to antigens to identify the presence of a substance.

16 Oct 2017

ITL Group returns to MEDICA 2017 to discuss future of diagnostic devices

Leading medical device design and manufacturing company, ITL Group returns to the MEDICA tradeshow in Düsseldorf, Germany this November with a simple message – ‘your future rests with us.’

From Vitl Life Science Solutions 6 Oct 2017

FDA approves FreeStyle Libre Flash Glucose Monitoring System for adult patients with diabetes

The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip.

27 Sep 2017

Simple blood test provides new treatment choices to lung cancer patients

A simple test which can detect gene mutations in tumour DNA from blood samples is giving new choices to lung cancer patients with faster diagnosis and improved access to life changing drugs.

15 Sep 2017

Nanoparticle bling could increase sensitivity of test strips for better cancer detection

The most common test strip people might think of for diagnosis is a home pregnancy test. Pregnant women have steadily increasing levels of the biomarker human chorionic gonadotropin (hCG), which is easily detectable in urine and a thin, colorful strip of antibodies will appear when hCG is present.

13 Sep 2017

FDA grants clearance for first 2D digital mammography system with patient-assisted compression

Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.

1 Sep 2017

Expanding clinical flow cytometry portfolio unveiled by Beckman Coulter at AACC

Beckman Coulter Life Sciences unveils its expanding clinical flow cytometry portfolio at the 69th American Association for Clinical Chemistry.

From Beckman Coulter Life Sciences - Flow Cytometry 28 Jul 2017

Roche receives FDA clearance for new Troponin T test to detect patients with suspected heart attack

Roche announced that it has received the 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected heart attack.

27 Jul 2017

ClearLLab reagents to aid the detection of leukemia and lymphoma receive FDA clearance

Beckman Coulter welcomes FDA announcement for received regulatory clearance to market its ClearLLab reagents for in vitro diagnostic use in the US.

From Beckman Coulter Life Sciences - Flow Cytometry 14 Jul 2017

FDA authorizes marketing of test to aid in diagnoses of serious cancers

The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

29 Jun 2017

EKF POCT HbA1c testing confirmed as comparable to lab-based HPLC

EKF, announces recent study confirmed Quo-Test A1c point-of-care testing analyzer comparable to a lab-based HPLC system for the measurement of HbA1c.

From EKF Diagnostics 21 Jun 2017

Illumina introduces fast, highly accurate Veriseq NIPT Solution in the European Union

Illumina, Inc. today announced the launch of the VeriSeq™ NIPT Solution, a CE-IVD marked next-generation sequencing (NGS)-based approach to noninvasive prenatal testing, including CE-IVD marked library prep and analysis software, which enables laboratories in the European Union to bring efficient, highly accurate NIPT in-house.

10 Apr 2017

ITL Group celebrates 40 years of medical device manufacturing

2017 marks a milestone celebration for contract medical device company the ITL Group as they celebrate 40 years in the industry.

From Vitl Life Science Solutions 21 Feb 2017