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White Papers and Videos

CDC to Invest $2.1B to Expand Infectious Disease Detection, Prevention Efforts

Some of the funding will be used to increase state and regional laboratory capacity to conduct surveillance for emerging pathogens.

FDA Warns of Potential False Positives With Abbott SARS-CoV-2 Molecular Tests

The agency said the issue could be related to current mixing parameters of the PCR reaction mixture resulting in overflow in wells of the reagent tray.

Thermo Fisher Scientific Expects 12 Percent Revenue Growth in 2022

The guidance for next year assumes, among other things, $6.0 billion in revenue from clinical research services provider PPD, which Thermo Fisher is set to acquire this year.

New Facial Analysis Tool From Children's National Hospital Screens for Genetic Diseases

The technology has been licensed by MGeneRx, which plans to commercialize it in the US first, then expand to low- and middle-income countries.

In Brief This Week: Roche, Myriad Genetics, Danaher, and More

News items for the in vitro diagnostics industry for the week of Sept. 13, 2021.

UK Opens Consultation on New Diagnostics Regulations

The UK government said it intends to develop a new regime for IVDs that improves safety and is transparent and responsive.

CareDx: Art Torres

Member for

1 year 4 months
Submitted by crainapiuser on Fri, 09/17/2021 - 09:05

CareDx has appointed patient advocate, political leader, and former state senator Art Torres to its board of directors.

Torres began his career by working alongside Cesar Chavez for the rights of farm workers in California. He later served for 20 years in the California legislature, chairing the State Assembly’s Health Committee, and then was elected as chair of the State Democratic Party. He is also a colon cancer survivor.

Identifying a Clinically Relevant Mitochondrial Variant With NEW CentoXome

White Paper

This white paper from Centogene presents a case study in which a physician employed the New CentoXome whole-exome sequencing test to diagnose mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS syndrome) in a 20-year-old patient.

Verichem Laboratories Electrolyte Standard Kit, ISE Standard Kit

Member for

7 months 4 weeks
Submitted by [email protected] on Thu, 09/16/2021 - 11:07

Verichem Laboratories has launched the Electrolyte Standard Kit and the ISE Standard Kit. Both are liquid stable, ready-to-use kits with reference materials for calibration and calibration verification of clinical electrolyte testing systems. The Electrolyte Standard Kit contains chloride, ionized calcium, lithium potassium, and sodium and has a 21-month stability claim. The ISE Standard Kit contains chloride, litium, potassium, and sodium and has an 18-month stability claim. Both kits are free of azides, glycols, surfactants, and other potentially interfering substances.

Sebia, Metafora Biosystems Partner to Develop IVD Tests

Metafora's single-cell diagnostic platform uses artificial intelligence to detect cellular metabolism anomalies.

Thermo Fisher Scientific Receives CE Mark for TaqPath COVID-19 RNase P 2.0 Testing Kit

The assay, which received FDA Emergency Use Authorization in July, is designed to compensate for current and future COVID-19 viral mutations.

Castle Biosciences Receives New York State Approval for DecisionDx DiffDx-Melanoma Test

The gene expression profile assay is meant to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

FDA Approves Takeda's Exkivity With Thermo Fisher CDx for EGFR Exon20 Insertion-Positive NSCLC

This is the first time the FDA has approved a drug specifically for NSCLC patients who harbor rare EGFR Exon20 insertion mutations.

Hong Kong-Based Prenetics to go Public via SPAC

The company recently launched a point-of-care and at-home rapid health monitoring system for infectious diseases.

Owlstone Medical: Mark Capone

Member for

7 months 4 weeks
Submitted by [email protected] on Thu, 09/16/2021 - 09:09

Owlstone Medical has appointed Mark Capone to its board as an independent non-executive director. Capone recently served as president and CEO of Myriad Genetics, and prior to Myriad, he spent 17-years at Eli Lilly in various positions. He is president and CEO of Precision Medicine Advisors and a non-executive board member of Abcam, Micoba Life Sciences, and NephroSant.