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Regulatory Approval: Page 2
PerkinElmer inks deal to divest businesses
Of the purchase amount, $2.3 billion will be received at closing and $150 million will be payable contingent on the exit valuation New Mountain receives on a sale or other capital events related to the business. The new ownership is expected to retain the PerkinElmer name and brand for the applied, food, and enterprise services businesses.
July 31, 2022
Pictor receives CE Mark for COVID-19 test
The PictArray SARS-CoV-2 assay is the first test of its kind, according to the company. The test enables personalized COVID-19 assessments by detecting if a patient has antibodies from a previous infection of SARS-CoV-2 (from spike protein and nucleocapsid protein antibodies) or from vaccination alone (SP antibodies only).
June 22, 2022
Grail, AstraZeneca to collaborate on companion diagnostic tests
The firms will focus first on developing CDx tests using Grail's methylation platform to identify and recruit patients with high-risk, early-stage cancer for AstraZeneca's clinical studies.
June 1, 2022
Enzo's HPV test approved by New York health department
Ampiprobe is the company's PCR-based test which can detect 14 high-risk HPV variants. The company said this approval positions it to pursue U.S. and international regulatory approvals.
April 18, 2022
Fulgent to acquire Inform Diagnostics
Under the agreement, Fulgent will acquire Inform Diagnostics at about $170 million, to be paid from cash on hand. The acquisition is expected to close during the second quarter of 2022, subject to closing conditions, including regulatory approvals.
April 18, 2022
SQI, Owlstone partner on breath-based biomarkers for lung tests
Under the MOU, the companies will agree on regulatory strategies for independent clinical trials being conducted by Owlstone. The trials are testing the validation of breath-based volatile organic compounds to diagnose invasive aspergillosis.
January 24, 2022
Blood test may predict Alzheimer’s 3.5 years before diagnosis
Researchers find hidden bacteria that pose antimicrobial resistance risk to hospital patients
Quest Diagnostics Q4 revenues down 15% on COVID testing but base business grew
SD Biosensor, SJL Partners complete acquisition of Meridian Bioscience
OIG report outlines challenges with CDC-supported COVID-19 vaccination programs
Duke University developing blood test to detect osteoarthritis progression in the knee
Labcorp to acquire Personal Genome Diagnostics
Under the terms of the agreement, Labcorp will pay $450 million in cash at closing and up to an additional $125 million on achieving future performance milestones, the company reported. The transaction is expected to close in the first half of 2022 and is subject to customary closing conditions and regulatory approvals.
December 22, 2021
Labcorp to buy Toxikon
Once completed, the acquisition will create a strategic footprint for Labcorp to partner with pharmaceutical and biotechnology clients in the Boston area and bolster its strong nonclinical development portfolio, company representatives said.
November 17, 2021
FDA approves marketing of BioFire COVID-19 test
The diagnostic test had emergency use authorization and received approval for marketing through the FDA's "de novo" pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The de novo request was based on additional data showing validation beyond what is needed for emergency use authorization.
March 17, 2021
Bluejay teams up with Toray on COVID-19 point-of-care test
Toray's Symphony interleukin 6 (IL-6) technology is a portable test for quantitation of IL-6 in whole blood for COVID-19 patients who present progressing symptoms and have a high risk of needing intubation with mechanical ventilation, according to Bluejay.
December 7, 2020
Exact to acquire early cancer detection firm for $2B
Thrive has developed CancerSeek, a blood-based cancer detection test that utilizes mutation and protein biomarkers. An early-stage version of the liquid biopsy detected 10 different types of cancer, including seven with no recommended screening guidelines, Exact noted.
October 27, 2020
Baxter, BioMerieux make deal on kidney test
The Nephrocleartm CCL14 test is in development for use in assessing the risk of developing persistent severe acute kidney injury (AKI). The agreement is part of a previously announced collaboration between the companies to improve identification and treatment of AKI.
September 15, 2020
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