Regulatory Approval: Page 4

Olive Diagnostics receives CE Mark for AI-based urinalysis
By LabPulse.com staff writers
Its device detects molecular components in the urine and generates data that are sent to the cloud and can be read by a treating physician.
October 3, 2022
Lab Urine Test Strip 400
Leuko nabs $5M for validation of WBC monitoring technology
By LabPulse.com staff writers
HTH VC, Good Growth Capital, IAG Capital Partners, Nina Capital, and angel investors provided the funding, Leuko said. The funding will allow the company to accelerate clinical trials with the aim of obtaining regulatory approval in collaboration with leading cancer centers, including the MD Anderson Cancer Center and Boston Medical Center in the U.S., and Dexeus and Hospital 12 de Octubre in Spain.
September 22, 2022
2021 01 08 22 20 9120 Cancer Cell Target2 400
PerkinElmer inks deal to divest businesses
By LabPulse.com staff writers
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
2020 01 09 22 46 7361 Business Deal Corporate 400
Pictor receives CE Mark for COVID-19 test
By LabPulse.com staff writers
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
2020 05 05 20 17 1261 Sars Co V 2 Antibodies 400
Grail, AstraZeneca to collaborate on companion diagnostic tests
By LabPulse.com staff writers
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
2019 08 12 20 23 3708 Lab Blood Centrifuge 400
Enzo's HPV test approved by New York health department
By LabPulse.com staff writers
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
2020 07 29 23 56 6775 Hpv Infection 400
Fulgent to acquire Inform Diagnostics
By LabPulse.com staff writers
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
2020 09 08 18 51 2374 Business Handshake Meeting 400
SQI, Owlstone partner on breath-based biomarkers for lung tests
By LabPulse.com staff writers
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
2019 08 30 20 54 9805 Aspergillus Fungus Lung 400
Labcorp to acquire Personal Genome Diagnostics
By LabPulse.com staff writers
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
2019 04 04 00 32 2089 Blood Sample Technician 400
Labcorp to buy Toxikon
By LabPulse.com staff writers
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
2020 09 08 18 51 2374 Business Handshake Meeting 400
FDA approves marketing of BioFire COVID-19 test
By LabPulse.com staff writers
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
2020 07 16 23 29 1615 Laboratory Scientist Biosafety 400
Bluejay teams up with Toray on COVID-19 point-of-care test
By LabPulse.com staff writers
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
2019 11 15 22 54 6305 Business Hands 400
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