Market Insight Blog

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

Outbreak Intelligence Brief: Ebola Activity in East & Central Africa (2026)

Ebola remains a critical public health priority in East and Central Africa, with recent confirmed infections in Uganda linked to cross-border transmission from the Democratic Republic of the Congo (DR...

Published on 2026-05-25 14:54:14 by giendi

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Ebola infection is confirmed through laboratory testing, primarily RT PCR.

Testing is tightly controlled due to biosafety risks and is only performed for symptomatic individuals with epidemiologic risk factors.

The global Ebola diagnostics market is entering a new growth pha...

Published on 2026-05-18 13:34:39 by giendi

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What the Baric Case Reveals About the Future of Virology, Policy, and Pandemic Preparedness?

The unfolding case around Dr. Ralph Baric—one of the world’s most cited coronavirus researchers—highlights a critical tension at the intersection of science, policy, and public perception.

HHS has mov...

Published on 2026-05-15 12:26:38 by giendi

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Which are the companies that offer hantavirus tests to clinical laboratories?

Hantavirus testing in the U.S. remains a small but strategically important niche within the broader infectious disease diagnostics market—supported by a concentrated set of kit manufacturers and high ...

Published on 2026-05-14 19:58:01 by giendi

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The genetic basis of the Healthy Blood Donor Effect (HDE)

New research from the European Journal of Human Genetics sheds light on the “Healthy Donor Effect” — and the findings go far beyond eligibility criteria. A large study of more than 53,000 active blood...

Published on 2026-04-28 17:40:07 by giendi

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For the first time, WHO will endorse a new class of near point of care (NPOC) molecular tests designed to offer lower unit costs than existing molecular platforms.

WHO just signaled a major shift in global TB diagnostics — opening new strategic opportunities for molecular testing companies, investors, and global health implementers. In its upcoming guideline upd...

Published on 2026-03-18 14:21:50 by giendi

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Viscoelastic diagnostics is entering a new acceleration phase.

Viscoelastic diagnostics is entering a new acceleration phase — and the implications for investors and BD teams are significant.
Recent advances in viscoelastic and elastography‑based technologies are...

Published on 2026-03-16 17:41:26 by giendi

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RSV rapid antigen testing (Ag RDT) in primary care reduces inappropriate antibiotic prescribing

🦠 New JAMA Study: RSV Rapid Testing Cuts Unnecessary Antibiotic Use in Young Children A new JAMA Network Open investigation offers compelling evidence that RSV rapid antigen testing in primary care me...

Published on 2026-03-10 12:28:04 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 dia...

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 millio...

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 ris...

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 platfo...

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 through 2022, in...

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.

Ne...

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 major...

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 agreement with...

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. Across...

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 outlined two major...

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

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