Revival of VALID Act Draws Mixed Response

March 9, 2020 — The revival of legislation to change the regulation of laboratory-developed tests (LDTs) has drawn a mixed response. The reintroduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act is intended to remove barriers that are believed to have impeded the U.S. government’s response to the coronavirus epidemic. The issue of diagnostics […]

Boost for Remote Patient Monitoring in COVID-19 Bill That Passed House, Senate

The House of Representatives and Senate today passed an $8.3 billion spending package to help providers and local governments handle the spread of the coronavirus and to boost the development of vaccines and tests of the virus.  While vaccine support and spending on healthcare is expected, the bill also  boosts telehealth solutions with financial support […]

Coronavirus Mortality Rate Upped to 3.4%; Increasing Need for Testing

With the world’s major health organization upping the mortality rate to 3.4%, there is increased need for a working rapid test for COVID-19 to be able to properly isolate patients and protect providers. The World Health Organization (WHO) has raised its estimate of the mortality rate of patients infected with the novel coronavirus to 3.4% […]

Thermo Fisher set to acquire Qiagen after all in $11.5B deal

Courtesy of LabPulse.com March 3, 2020 — After an on-and-off courtship, Thermo Fisher Scientific announced it is set to acquire Qiagen in a deal worth $11.5 billion. The transaction will give Thermo Fisher access to Qiagen’s molecular diagnostics expertise and potentially lead to faster development of diagnostic tests. The deal values Qiagen at 39 euros ($44) per […]

Expect to Hear a Lot of Talk about Coronavirus and Molecular Point of Care

A Harvard Business Review  article calls for molecular point of care to step in to detect #coronavirus. You’ll hear a lot of this in coming weeks, we think.  Molecular point of care is less than 10 years old but has shown promise in flu/strep, other respiratory pathogens. They are in the right place at the right […]

Molecular Diagnostics for Cancer Grows, Fueled by NGS-based Testing

Cancer diagnostics is a highly dynamic field that consists of various types of platforms. Molecular diagnostics platforms are increasingly becoming popular as they enable accurate diagnosis as well as prognosis evaluation, which are important for treatment decisions. In 2019, the market for molecular cancer diagnostics, including histology and assays, reached $1,600 million, increasing 11.5% over […]

Clinical Labs are a 120+ Billion-Dollar Industry Globally

The global market for clinical laboratory services is estimated at $121.5 billion for 2019.  This is up 2.9% from the estimated value in 2010 of $93.9 billion, according to a new Kalorama Information report.  (https://kaloramainformation.com/product/clinical-laboratory-services-market-5th-edition/ ) Growth is driven by  an aging population, a growing incidence of chronic diseases, but it is more than that.  The […]

State of Mass Spectrometry in Clinical Labs

February 3, 2020 — For years, mass spectrometry found extensive use as a valuable analytical tool in industries ranging from chemical processing to drug discovery and development. Now the technology has transitioned into the clinical lab, with the commercialization of mass spectrometry platforms for microbial identification. In the clinical setting, mass spectrometry has gained attention as […]

Roche and Meridian Among Vendors with 2019-nCoV-related IVD products; FDA Steps in.

Major IVD vendors, especially those common in reverse transcription PCR (RT-PCR), went right to work in the recent coronavirus outbreak.  This as the FDA announced plans to make emergency test deployment easier.  The recent novel coronavirus, responsible for thousands of infections and over 170 deaths in the Hubei province in China at the time of […]

Barbershop Point of Care Testing? Study Shows it Might Be Effective

Point-of-care has potential to reach patients who may not even be aware they are patients, as evidenced by a recent study in a major journal that documented an unusual point-of-care venue: barbershops were found to be effective locations for on-the-spot testing of black men for hemoglobin A1c (HbA1c), according to a study published January 27 […]