Exact Sciences Archives - Medical Design Sourcing

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…

Exact Sciences launches cancer therapy selection test

[Image courtesy of Exact Sciences]Exact Sciences (Nasdaq:EXAS) announced that it launched its OncoExTra cancer therapy selection test in the U.S.

OncoExTra is a next-generation sequencing, comprehensive DNA- and RNA-based genomic test. Madison, Wisconsin-based Exact Sciences designed it to provide doctors and patients a complete molecular picture of the patient’s cancer. The test provides reliable and actionable results personalized to each patient.

Comprehensive genomic profiling (CGP) helps patients understand their cancer and guide treatment. Personalized medicine powered by CGP helps oncologists understand the unique biology of each patient’s tumor. Oncologists can then prescribe treatments determined to offer the best outcomes, according to a news release.

“The OncoExTra test substantially enhances our ability to characterize and understand solid tumors, giving our patients the best chance at treating their cancer successfully,”…

Phillips-Medisize, Exact Sciences to collaborate on colorectal cancer screening

Phillips-Medisize and Exact Sciences (NSDQ:EXAS) today announced a collaboration to advance early cancer detection.

The collaboration centers around Exact Sciences’ Cologuard, the first and only FDA-approved, non-invasive stool DNA screening test for colorectal cancer, according to a news release.

Phillips-Medisize, a Molex company, said the collaboration will seek to focus on the patient experience through the simplicity and convenience of at-home testing. The company developed new tooling to safeguard against inadvertent leaks while meeting specifications and tolerances required to produce the highest levels of product quality.

Exact Sciences was able to utilize supply chain flexibility to acquire all components needed to rapidly scale production of the kit, while Phillips-Medisize located and validated alternate supply sources, conducted risk assessments and forecasting and created sourcing and procurement plans to protect against unplanned disr…