FDA proposes boosted regulations of lab-developed tests

The FDA today announced a proposed rule that would make it explicit that in vitro diagnostics are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.

The agency is publishing the full rule proposal in the Federal Register.

“A growing number of clinical diagnostic tests are being offered as laboratory-developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” FDA Commissioner Dr. Robert M. Califf said in a news release. “According to the Centers for Disease Control and Prevention, 70% of today’s medical decisions depend on laboratory test results. Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health.”

The move marks a break from decades of more hands-off regulation. Historically, FDA offic…

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The top IVD innovation news stories of 2023 — so far

[Image courtesy of the National Cancer Institute via Unsplash]This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space.

According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using tiny sensors stuck under to skin to measure blood glucose — and much more.

Here are five IVD innovation stories that have caught our attention so far this year:

5. Hologic wins FDA clearance for COVID-flu-RSV assay

Last winter, the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. So it was welcome news in May when Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Read the full story a…

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Lunaphore and Massachusetts General Hospital partner on spatial biology-based cancer diagnostics

Life sciences company Lunaphore (Lausanne, Switzerland) will collaborate with the Pathology Department at Massachusetts General Hospital to create an in vitro diagnostic (IVD) to evaluate the sensitivity of solid tumors to poly-ADP ribose polymerase (PARP) inhibitors.

Lunaphore’s chip technology can extract spatial proteomic and genomic data from tumors.

The project will first focus on ovarian, breast and prostate cancers.

PARP inhibitors work by preventing cancer cells from repairing damaged DNA.

COMET 6-plex on breast cancer. Image courtesy of Lunaphore.

“The DNA repair pathway called homologous recombination is of clinical interest as tumors with homologous recombination deficiency (HRD) have been found to be sensitive to PARP inhibitors,” said Diego G. Dupouy, chief technology officer of Lunaphore, in a statement. “However, current methods of identifying HRD in tumors have been varie…

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