Roche ($RHHBY) got a green light from U.S. regulatory authorities to expand the use of two tests from its cobas assay line used to detect serious viral infections like HIV, hepatitis B and C and West Nile virus (WNV).
|Roche's cobas MPX|
The Swiss company said its cobas MPX and cobas WNV assays can now be used for testing of human organ and tissue from cadavers in markets where the tests have a CE mark. The new claims allow for pre-implantation screening of organ and tissue donations so transplant recipients don't receive infected blood.
"Testing organs and tissue for transplant with the cobas MPX and cobas WNV assays allows healthcare professionals to provide increased safety for patients at a critical point in their lives," said Paul Brown, head of Roche Molecular Diagnostics, in a statement. "Providing advanced molecular diagnostic assays on the cobas 6800/8800 system is part of our comprehensive solution for donor screening and emphasizes our commitment to protecting patient safety worldwide."
The cobas MPX is a real-time PCR multiplex that detects and identifies hep B, hep C and the two strains of HIV--HIV-1 and HIV-2--using a single blood sample. Also a real-time PCR test, the cobas WNV assay tests for the two lineages, or types, of West Nile virus and provides broad coverage of other flaviviruses that can cause transfusion-transmitted infectious diseases.
Roche claims that the cobas MPX and cobas WNV assays provide the fastest time to results compared to other tests. The urgent nature of organ transplant procedures from deceased donors means screening for infectious disease needs to be carried out as quickly as possible to preserve organ function up until transplantation.
A global leader in blood and plasma screening, Roche's diagnostics arm has been busy in the space lately. Following a deal earlier this month with Ariosa for prenatal diagnostics, Roche also just launched its new Laboratory-in-a-tube (Liat) technology, a molecular diagnostic system it acquired in the buyout of iQuum back in April. The company also scooped up AvanSci Bio's tissue dissection technology recently to diversify its offerings.
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