FDA WATCH

Agency Unveils Guidance for Full Approval of SARS-CoV-2 Tests

Even though the COVID-19 public health emergency (PHE) can’t last forever, according to US chief medical advisor Dr. Anthony Fauci, coronavirus may never completely disappear from the face of the … [Read more...]

DX DEALS

Exact Sciences Ends Cologuard Co-promotion Partnership with Pfizer

One of the most dynamic and significant marketing arrangements in the genetic cancer lab testing market over the last few years is coming to an end. On Nov. 30, Exact Sciences told investors it is … [Read more...]

COVID TESTING

Omicron Surge Creates Nationwide Shortage of COVID-19 Tests

Even before Omicron, demand for COVID-19 tests was on a major rise. The emergence of the new highly transmissible variant has now stretched testing supplies and capabilities to the breaking point. … [Read more...]

INVESTMENT TRENDS

Huge Digital Health Fundraising Growth May Not Continue in 2022

Digital health companies continue to raise capital at unprecedented rates. In 2020, total fundraising in digital health topped the $10 billion barrier for the first time at $14.6 billion. With over … [Read more...]

Inside the Lab Industry

Q3 Diagnostics Revenues Remain Strong Despite Fall in COVID-19 Testing

Lab companies posted another outstanding quarter of growth in Q3, with the recovery of core markets more than offsetting declines in COVID-19 tests and testing products. While lower on a sequential … [Read more...]

DX Deals

New Saliva-Based Pregnancy Test May Revolutionize POC Diagnostics

The global pandemic has forced test makers to accelerate development of innovative rapid, point-of-care diagnostics. While COVID-19 detection remains the paramount objective, pandemic pressures may … [Read more...]

FDA Watch

HHS Restores Agency’s Premarket Review of LDTs

For over a year, makers of laboratory developed tests (LDTs) have been free of the yoke of US Food and Drug Administration (FDA) premarket review requirements. But on November, the Department of … [Read more...]

M&A Report

The Top 10 Diagnostics Deals of 2021

As expected, M&A activity in the labs and medical diagnostics space bounced back in terms of both deal volume and value this year. There were seven different billion-dollar acquisitions in 2021, … [Read more...]

Emerging Markets

Technological Advances Expected to Drive Huge Growth in Diabetes Testing

Diabetes remains a major clinical challenge that generates $760 billion in global spending per year. Diagnostic testing is expected to reach $18.9 billion in 2021, a total that is likely to grow … [Read more...]

Emerging Tests

Leading COVID-19 Test Makers Say Their Products Can Detect New Omicron Variant

The World Health Organization (WHO) has declared the new omicron (B.1.1.529) viral mutation a “variant of concern.” But leading makers of COVID-19 diagnostic tests in the US seem unfazed and insist … [Read more...]


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