Diaceutics Blog | Diaceutics

Payer Research

12th December 2018
Much is known about the process payers follow when it comes to coverage and reimbursement of new drugs on their formularies, including oncology drugs. But the expanding field of precision medicine and companion diagnostics have yielded a new field of market access and reimbursement, namely for the

Minimal Residual Disease (MRD), Lab Mapping and Market Access

18th October 2018
The clinically most useful MRD test and targets are not yet determined.1 More accurate methods to measure MRD are being developed and MRD testing is now part of standard treatment regime for some diseases such as ALL and is being validated for other conditions including acute myeloid leukemia

Biomarker qualification and diagnostic sensitivity in general medicine

18th October 2018
The FDA has established the Biomarker Qualification Program (BQP) to work with external stakeholders to develop and qualify measurable and reliable biomarkers for a specific use in drug development. Under the BQP process a manufacturer submits evidence to the FDA providing details about the

Real Time Oncology Review (RTOR) – implications for launch and commercialization

23rd August 2018
The FDA intends to make the development and review of cancer drugs more efficient under the Real Time Oncology Review (RTOR) pilot program. Under this supplemental applications pilot, launched last year, evaluation of clinical data begins as soon as clinical data becomes available and results are

Innovation in Liquid Biopsy

22nd August 2018
The term “liquid biopsy” is defined by the College of American Pathologists (CAP) as assays that analyze proteins, DNA, or cancer cells that circulate in the blood. There is growing interest in the less invasive, less complicated liquid biopsy as an alternative option to traditional biopsies in

Trends in FLT3 testing

7th August 2018
The FMS-like tyrosine kinase 3 gene (FLT3) marker is present in 25-30% of all AML patients and indicates a poorer prognosis.  The testing landscape is evolving and FLT3 diagnostic testing is now used in efficacy-based patient stratification, safety-based patient stratification and ongoing

Spark and laboratory data

25th July 2018
At Diaceutics we are using a number of tools to leverage our data and to generate actionable insights.  We mine data to forecast market trends and to understand the changing biomarker landscape.  We are able to understand the use of new biomarker targets over time, review the dissemination of new

Precision Medicine (PM) and Artificial Intelligence (AI) algorithms – risk of bias in treatment

26th June 2018
Precision medicine is more impactful when we build a story through use of a complete and meaningful dataset. Many publications discuss the idea that precision medicine relies on smart technology and this is true. At Diaceutics we believe that smart technology needs to be paired with the right

CMS decision on NGS coverage is a big step forward for patients and laboratories

20th April 2018
By Jeff Schreier, Senior Director, Marketing and Robert Feeney, Marketing Director, Global Lab Relations, Diaceutics.  A hurdle has just been cleared for patients and the laboratories who serve them. On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National

Diaceutics, Intel and Lenovo advance patient care using AI and workstations powered by Intel® Xeon® Scalable processors

5th March 2018
Collaboration will help to organize and categorize patient testing data using artificial intelligence It is a revolutionary method which could help to identify new patient subsets The aim is to further improve the diagnosis and treatment of patients Since it was established, Diaceutics has focused

It’s a boy! Now where’s that genetic testing kit? 

28th February 2018
In a big step forward for early diagnostic use, US company Sema4 has begun offering a newborn genetic screening kit that analyses 166 genes for 193 disorders and 38 common pediatric diseases. Sema4 is a “health information company founded on the idea that more information, deeper

Could Crohn’s disease treatment become more precise?

19th February 2018
Crohn’s disease is an inflammatory condition that affects the gastrointestinal tract and can cause symptoms including abdominal pain, diarrhoea, bleeding, joint pain, mouth sores, fatigue and weight loss. The cause is unknown but bacteria and the immune system are implicated and there is
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