Liz Carey

Mergers & Acquisitions

$16.5B CDMO deal unhindered by role in broader pharma supply chain

Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.

December 11, 2024

Business Graph Money Stocks Social (1)

USPSTF proposes new cervical cancer screening guidelines

While some signals abroad favor HPV DNA testing, USPSTF stays focused on cervical cytology alone or in combination.

December 11, 2024

Pathology Pap Smear Cervical

Nationwide claims analysis questions value of multiplex molecular panels for UTI

Reimbursement for molecular syndromic panel testing for UTI may continue to face uncertainty.

December 10, 2024

2020 07 07 Clostridioides Difficile Cdc Social

FDA Warning Letter

FDA sounds bacteria alarms over CGMP violations in Maine

Tom's troubles highlight the importance of being inspection-ready.

November 21, 2024

Large language models tapped for speeding up clinical trial enrollment in U.S.

Meanwhile, the FDA envisions integrating more clinical trial activities into local healthcare facilities, roaming mobile research units, and through at-home lab testing kits.

November 19, 2024

Clinical Trial Data Network Social

AMP reviews pitfalls of NGS testing for SARS-CoV-2

Document offers key pre-analytical, analytical, and post-analytical considerations to help improve NGS-based surveillance programs.

November 15, 2024

Covid Treatment Doctor Social

Diagnostic Technologies

FDA fall IVD roundtable avoids LDT questions

In addition, CAP LDT webinar offers beginning guide for phase one compliance.

November 12, 2024

Diagnostic Analyzer Lab Pcr Social

Molecular Diagnostics

Fulgent Genetics wins $99M precision medicine contract with VA

The new award maintains Fulgent's focus on germline testing and also funds pharmacogenetic (PGx) testing.

October 31, 2024

Business Graph Money Stocks Social

Pathology and AI

Digital pathology rollouts race for proof-of-concept at national level

U.K. invests in clinical trial security while Australia's health minister issues powerful ultimatum.

October 29, 2024

Artificial Intelligence Ai Hand Social

Lucy Letby murder case flags immunoassays as unreliable for medical evidence

At least one pathologist has said it was wrong for scientists representing Liverpool Clinical Laboratories to insist insulin poisoning was the only explanation in a series of high-profile newborn deaths in the U.K., The Telegraph reported.

October 28, 2024

Gavel Handcuffs Proxima Studio

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Business Graph Money Stocks Social (1)

$16.5B CDMO deal unhindered by role in broader pharma supply chain

Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.

Handcuffs Gavel Social

Texas lab owner accused of $79M RPP fraud scheme

FDA sounds bacteria alarms over CGMP violations in Maine

Baby Infant Mom Closeup Social

Revvity broadens work in newborn testing for NHS England

Body composition in patients treated with Ozempic

Body composition in patients treated with Ozempic

$16.5B CDMO deal unhindered by role in broader pharma supply chain

Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.

December 11, 2024

Business Graph Money Stocks Social (1)

Texas lab owner accused of $79M RPP fraud scheme

By LabPulse.com staff writers

The DOJ implicated a Texas clinical laboratory owner and operator in respiratory pathogen panel testing fraud scheme.

November 25, 2024

Handcuffs Gavel Social

FDA sounds bacteria alarms over CGMP violations in Maine

Tom's troubles highlight the importance of being inspection-ready.

November 21, 2024

Revvity broadens work in newborn testing for NHS England

By LabPulse.com staff writers

Revvity, formerly PerkinElmer, will expand its work with Genomics England to continue the Generation Project.

November 20, 2024

Baby Infant Mom Closeup Social

Roche gets CE Mark for ovarian cancer CDx test

By LabPulse.com staff writers

Roche has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its companion diagnostic (CDx) test, which is designed to aid in identifying ovarian cancer patients eligible for targeted treatment with Abbvie's Elahere.

November 19, 2024

Ovarian Cancer2 Social

AMP reviews pitfalls of NGS testing for SARS-CoV-2

Document offers key pre-analytical, analytical, and post-analytical considerations to help improve NGS-based surveillance programs.

November 15, 2024

Covid Treatment Doctor Social

FDA fall IVD roundtable avoids LDT questions

In addition, CAP LDT webinar offers beginning guide for phase one compliance.

November 12, 2024

Diagnostic Analyzer Lab Pcr Social

Lucy Letby murder case flags immunoassays as unreliable for medical evidence

At least one pathologist has said it was wrong for scientists representing Liverpool Clinical Laboratories to insist insulin poisoning was the only explanation in a series of high-profile newborn deaths in the U.K., The Telegraph reported.

October 28, 2024

Gavel Handcuffs Proxima Studio

Digital pathology rollouts race for proof-of-concept at national level

U.K. invests in clinical trial security while Australia's health minister issues powerful ultimatum.

October 29, 2024

Artificial Intelligence Ai Hand Social

Caris Life Sciences embarks on 10K-sample breast cancer biomarker analysis project

By LabPulse.com staff writers

Caris will perform comprehensive molecular characterization of TAILORx tissue samples.

October 25, 2024

Dna Sequence (1)

ASCLS seeks support for med lab personnel act

By LabPulse.com staff writers

The proposed legislation includes loan repayment provisions and requires $25 million in the first year.

October 25, 2024

Washington Dc Capitol

Pathology groups' antitrust legal fight heats up

By LabPulse.com staff writers

A lawsuit in which Iowa pathologists are suing their former colleagues is escalating, with one side accusing the other of attempting to maintain a monopoly at the expense of patients.

October 24, 2024

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