Market Insight Blog

Stay updated with the latest insights and trends in the IVD market.

Influenza is being driven by an aggressive H3N2 subclade (K)

A new Washington Post analysis underscores a critical reality of the 2025–2026 respiratory season: flu and COVID‑19 are evolving differently, but their symptoms are increasingly overlapping—making d...

Published on 2026-03-04 12:56:31 by giendi

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Influenza is being driven by an aggressive H3N2 subclade (K)

A new Washington Post analysis underscores a critical reality of the 2025–2026 respiratory season: flu and COVID‑19 are evolving differently, but their symptoms are increasingly overlapping—making d...

Published on 2026-03-04 12:56:31 by giendi

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CMS considers expanding MolDX‑style oversight nationwide.

According to recent analyses, **billions of dollars in fraudulent Medicare payments** have flowed through non‑MolDX jurisdictions, particularly in states where pop‑up labs were able to bill tens of mi...

Published on 2026-03-03 14:35:27 by giendi

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A sharp rise in heart disease among young women by 2050 is emerging as one of the most important—and under‑recognized—public health trends, according to a Scientific American article. Circulation, Vol. 153. Published online February 25, 2026.

Heart Disease in Young Women Is Projected to Surge by 2050 — A Wake‑Up Call for Cardiovascular Prevention New projections highlighted by Scientific American show a dramatic shift in cardiovascular ...

Published on 2026-02-26 21:14:25 by giendi

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Strategic Update: LEX Diagnostics has received FDA 510(k) clearance and CLIA waived status for its LEX VELO point of care molecular diagnostics system

LEX Diagnostics just secured FDA 510(k) clearance and CLIA‑waived status for its ultra‑fast VELO PCR system—another major milestone in the evolution of point‑of‑care molecular testing. The VELO...

Published on 2026-02-20 14:22:58 by giendi

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Annual Report to the Nation on the Status of Cancer (2025)

# **Summary: Annual Report to the Nation on the Status of Cancer (2025)** The 2025 report shows a **continued, steady decline in U.S. cancer death rates** for men, women, and children from **2001 t...

Published on 2026-02-13 18:41:13 by giendi

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Personalis’ Medicare coverage wins for NeXT Personal MRD

Medicare’s expanding coverage of Personalis’ NeXT Personal® MRD assay is another major signal that ultra‑sensitive, tumor‑informed ctDNA testing is becoming a core component of cancer surveillance. ...

Published on 2026-02-12 20:24:39 by giendi

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Relax your tight end Super Bowl LX commercial.

Early PSA screening is one of the clearest examples of how a simple blood test can change outcomes. Prostate cancer affects roughly 1 in 8 people with a prostate, yet when it’s caught early, the five‑...

Published on 2026-02-11 00:04:00 by giendi

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OraSure Technologies has submitted two FDA 510(k) applications for a rapid molecular self-test for chlamydia and gonorrhea (CT/NG)

**OraSure Technologies has submitted two FDA 510(k) applications for a rapid molecular self-test for chlamydia and gonorrhea (CT/NG) and an at-home urine collection device (Colli-Pee), signaling a maj...

Published on 2026-01-29 12:43:30 by giendi

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Diasorin & Thermo Fisher Sign Exclusive U.S. Distribution Deal — A Major Move in Rapid Molecular POC Expansion

## **🔍 Diasorin & Thermo Fisher Sign Exclusive U.S. Distribution Deal — A Major Move in Rapid Molecular POC Expansion** Diasorin has entered an **exclusive U.S. hospital‑channel distribution agreem...

Published on 2026-01-26 18:42:06 by giendi

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Early Cholesterol Treatment Dramatically Lowers Lifetime Heart Risk — What New Evidence Shows

A new article just accepted for publication in the Journal of the American College of Cardiology (https://www.jacc.org/doi/10.1016/j.jacc.2025.09.1613) reports a powerful message for cardiovascular pr...

Published on 2026-01-26 11:53:01 by giendi

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JPM 2026 IVD Insights

The 2026 J.P. Morgan Healthcare Conference made one thing clear: In‑vitro diagnostics is entering a new era defined by AI‑enabled performance, precision partnerships, and disciplined execution. Acros...

Published on 2026-01-24 15:41:15 by giendi

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Diasorin’s CLIA‑Waived NES Launch Signals a New Phase in Molecular POC — What It Means for the Market

Diasorin just secured FDA 510(k) clearance and CLIA waiver for its first assay on the Liaison NES, a next‑generation molecular point‑of‑care platform capable of delivering PCR‑quality results in 15 mi...

Published on 2026-01-24 15:39:12 by giendi

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It’s not too late for flu vaccination

**It’s not too late for flu vaccination — and this season the "Super Flu is going around.** Medscape recently interviewed **Lisa Grohskopf, MD, MPH**, from the CDC’s Influenza Division, who outline...

Published on 2026-01-21 17:31:37 by Admin

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