Ron Shinkman

Los Angeles

Writer and Editor at Freelance

Editor and Reporter at Health Payer Specialist

Editor and Reporter at Financial Times

Articles

Diagnostics Pipeline: Savara Introduces Blood Test to Detect aPAP, a Rare Lung Disorder

2 days ago | g2intelligence.com | Ron Shinkman

Savara’s ClearPath assay needs just a few drops of blood to test for aPAP, a condition that can be difficult and invasive to diagnose
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say

3 weeks ago | g2intelligence.com | Ron Shinkman

Pre-submission and Q-Submission meetings apparently have been halted, for now
Further Details to Note about Updated Clinical Lab Director Qualifications

1 month ago | g2intelligence.com | Ron Shinkman

by | Mar 20, 2025 | CLIA-lca, CLIA-nir, CMS-lca, CMS-nir, Compliance-lca, Employment-lca, Lab Industry Advisor Put into place late last year, the new rules place more emphasis on formal and continuing education requirements Put into place late last year, the new rules place more emphasis on formal and continuing education requirements Subscribe to View Start a Free Trial for immediate access to this article...
Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously

1 month ago | g2intelligence.com | Ron Shinkman

The PCR-driven test provides results in about 20 minutes in non-laboratory settings
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move

1 month ago | g2intelligence.com | Ron Shinkman

Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
MeMed Sepsis Test Gains Breakthrough Device Designation

2 months ago | g2intelligence.com | Ron Shinkman

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to a new test from Israeli firm MeMed that can diagnose a suspected case of sepsis within minutes.1 Sepsis is the body’s severe inflammatory reaction to an infection. This inflammation can lead to clots in blood vessels, hampering blood flow to the body’s internal organs.
Labcorp, Quest, and ARUP Develop Bird Flu Tests with CDC Help

2 months ago | g2intelligence.com | Ron Shinkman

Three laboratories have quickly developed and released tests for H5N1 bird flu in conjunction with the Centers for Disease Control and Prevention (CDC). These partnerships reflect a recent trend of increased public-private partnerships in the laboratory industry to boost pandemic preparedness. The tests were developed and released by Labcorp, Quest Diagnostics, and ARUP Laboratories, according to the CDC and statements issued by the companies in recent weeks.
Could Health Coaching Be a New Opportunity for Labs?

Jan 24, 2025 | g2intelligence.com | Ron Shinkman

One of the largest laboratory companies in the United States has launched a new business focused on an unusual path: health coaching of individual patients. Quest Diagnostics has begun offering health coaching packages beginning at $225 apiece through its Pack Health subsidiary.
ProPhase Labs’ Resolution for 2025: Nail Down a ‘Liquidity Event’

Jan 9, 2025 | g2intelligence.com | Ron Shinkman

Facing recent tough times, biotech, genomics, and diagnostics company ProPhase Labs is taking equally tough measures to address losses. Ted Karkus, chairman and chief executive officer of ProPhase Labs, said repeatedly during the most recent of what his company calls videostreamed roadshows that he is seeking a “liquidity event.”1 The Garden City, NY-based ProPhase’s corporate footprint is not unlike a divining rod, with various businesses casting around for the liquidity its leader is seeking.
EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval

Dec 5, 2024 | g2intelligence.com | Ron Shinkman

The European Union (EU) is the second-largest market for laboratory businesses behind the United States. Its rules for approving and regulating laboratory tests and equipment are undergoing the biggest changes in decades—and these could over the longer-term make more lab companies seek initial regulatory approvals in the US. The most dramatic revision is coming to the overall regulatory framework for laboratory approvals.