How Is COVID-19 Evolving? It’s Not Like Flu or Colds

By Robert Michel | From the Volume XXXI, No. 11 – August 12, 2024 Issue

CEO SUMMARY: It’s been 53 months since the SARS-CoV-2 virus triggered the worst global pandemic since 1918’s influenza pandemic. The coronavirus continues to surprise public health officials as new variants are detected, along with a multi-year pattern of summer surges in new cases. T…

Read More

---

Identifying Current Lab Trends from Labcorp & Quest Experience

By Robert Michel | From the Volume XXXI, No. 11 – August 12, 2024 Issue

CEO SUMMARY: Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. Wi…

Read More

---

2023 Ranking of the World’s Top 13 IVD Corporations

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

BASED ON 2023 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) manufacturers continued to lead the global IVD market just as they did in 2022. They are: Thermo Fisher Scientific, Inc., Roche Holdings, Abbott Laboratories, and Danaher Corporation. Th…

Read More

---

June 10, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

Once a high-flier lab test manufacturer with a market valuation of $2 billion, Cue Health of San Diego filed for Chapter 7 bankruptcy on May 28. Analysts now say the company is valued at about $15 million. Founded in 2010, Cue Health was developing a test system that consumers could …

Read More

---

FDA Issues Memo to Reclassify Many High Risk IVD Assays

By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…

Read More

---

Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue

DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…

Read More

---

Labs Should Prepare for Arrival of ‘Perfect Storm’

By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue

CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…

Read More

---

Is There Evidence That Some Doctors Wish to Use Local Labs?

By Virchow | From the Volume XXXI, No. 3 – February 26, 2024 Issue

…

Read More

---

FDA & CMS Issue Letter, Agree on LDT Oversight

By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue

CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…

Read More

---

Published Data Show Claim Denials on the Rise, But Why?

By Virchow | From the Volume XXXI, No. 2 – February 5, 2024 Issue

…

Read More

---