Skip to main content

Biocare to Distribute Invitrogen's HER2 Test Kit

NEW YORK (GenomeWeb News) – Biocare Medical will distribute Invitrogen’s new SPOT-Light HER2 CISH Kit in the US under an exclusive agreement announced Monday after the close of the market.
 
The test, which received US Food and Drug Administration clearance in early July, can be used to assess whether breast cancer patients should be treated with Genentech’s Herceptin (trastuzumab). It marked the first premarket approval Invitrogen has received from FDA for a diagnostic product.
 
Biocare is a supplier of immunohistochemistry reagents, multiplex stains, and automated platforms for the anatomic pathology market. 
 
Laboratories purchasing Invitrogen’s HER2 test kit must complete Invitrogen’s HER2 CISH certification program, as required by the FDA clearance. The firm expects the primary users to be pathologists, oncologists, and histotechnologists who determine the best course of treatment for breast cancer patients.
 
“This product is the first FDA approved product to provide the confidence and objectivity of in situ hybridization with the ease of immunohistochemistry, enabling a wider number of anatomic pathology laboratories to perform this critical test,” Biocare CEO Roy Yih said in a statement.

The Scan

Pfizer-BioNTech Seek Full Vaccine Approval

According to the New York Times, Pfizer and BioNTech are seeking full US Food and Drug Administration approval for their SARS-CoV-2 vaccine.

Viral Integration Study Critiqued

Science writes that a paper reporting that SARS-CoV-2 can occasionally integrate into the host genome is drawing criticism.

Giraffe Species Debate

The Scientist reports that a new analysis aiming to end the discussion of how many giraffe species there are has only continued it.

Science Papers Examine Factors Shaping SARS-CoV-2 Spread, Give Insight Into Bacterial Evolution

In Science this week: genomic analysis points to role of human behavior in SARS-CoV-2 spread, and more.