Three former officials with Magellan Diagnostics Inc., have entered guilty pleas in connection with faulty tests for lead poisoning that were widely used across the U.S. between 2013 and 2017. While former CEO Amy Winslow and two others will not be sentenced until later this year, all three face possible prison terms of three years or more and fines of as much as $250,000, highlighting the hazards of a lack of scruples with regard to compliance with U.S. FDA regulations.

The €1.6 million (US$1.7 million) in seed funding that MSInsight SAS recently raised is vital for the next phase of growth of the company, Arnaud Cutivet, president and co-founder, told BioWorld. MSInsight is developing a software, MSIcare, which uses sequencing technology to detect microsatellite instability (MSI) in solid tumors and liquid biopsies.

With an at least $60 billion total addressable market, the liquid biopsy sector offers abundant opportunity for multiple companies to swim to the top. The six largest companies in the pool have just dipped their toes in the water, with a total penetration of only 10%, a white paper from RBC indicates.

Samsung Life Science Fund made its first strategic investment of the year into C2N Diagnostics LLC, underscoring the rising potential of blood-based diagnostics in detecting and monitoring the risk of Alzheimer’s disease for the masses.

The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.

Repligen Corp. acquired 908 Devices Inc.’s desktop portfolio of four devices for bioprocessing process analytical technology (PAT) applications for $70 million in cash.

The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.

Scientists at the University of Aberdeen developed a new scanner that distinguishes breast tumor material from healthy tissue more accurately than current magnetic resonance imaging (MRI) methods.

The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.