Skip to main content
Premium Trial:

Request an Annual Quote

PerkinElmer, FDA Make Deal; Firm Resumes Selling Neonatal Dx Kits

NEW YORK, Feb. 16 (GenomeWeb News) - PerkinElmer "has reached agreement" with the US Food and Drug Administration, and will resume making and shipping neonatal diagnostic kits at its Norton, Ohio facility, the company said late last week.

Under the agreement, which enables PerkinElmer to immediately restart   producing and shipping the chemistry and isoelectric-focusing kits, the company will submit the products to additional undisclosed testing, and offer additional labeling advising proper use.

As GenomeWeb News reported Feb. 5, the FDA had seized the PerkinElmer kits because they were "adulterated under the federal Food, Drug, and Cosmetic Act." In the  statement, the FDA said that the US District Court for the Northern District of Ohio had given it a warrant to seize the kits in PerkinElmer's Norton facility, and that the US Marshal's service had executed the warrant Feb. 4.

The FDA said the kits, which are used to screen for genetic diseases such as sickle cell anemia and multiple sclerosis, "were not manufactured in accordance with FDA's good manufacturing practice quality system regulation."

The Scan

Interfering With Invasive Mussels

The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels.

Participation Analysis

A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports.

Right Whales' Decline

A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC.

Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map

In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.