FDA News

FDA expands clearance of ipsogen JAK2 assay for myeloproliferative neoplasms

The FDA expanded clearance of the ipsogen JAK2 RCQ PCR Kit for supplemental use in the diagnosis of all myeloproliferative neoplasms, according to a company press release.

The ipsogen JAK2 RGQ PCR Kit (Qiagen) — reviewed under a 510(k) pathway — is a qualitative in vitro diagnostic test for real-time polymerase chain reaction on the Rotor-Gene Q MDx instrument (Qiagen) to detect the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood.

As HemOnc Today previously reported, the test previously received marketing authorization for detection of mutations affecting the JAK2 gene among patients with suspected polycythemia vera.

The FDA clearance now includes indications for detection of essential thrombocythemia and primary myelofibrosis. The test is intended to be used in conjunction with other factors to evaluate suspected myeloproliferative neoplasms.

“We are eager to expand the use of our ipsogen JAK2 assay, which is already available in Europe and other markets, for use in a wider range of patients in the U.S.,” Thierry Bernard, senior vice president and head of Qiagen’s Molecular Diagnostics Business Area. “Our JAK2 assay makes it easier for hematologists and oncologists to follow recommended diagnostic testing algorithms and international guidelines for their patients suspected of having [myeloproliferative neoplasms].”

The FDA expanded clearance of the ipsogen JAK2 RCQ PCR Kit for supplemental use in the diagnosis of all myeloproliferative neoplasms, according to a company press release.

The ipsogen JAK2 RGQ PCR Kit (Qiagen) — reviewed under a 510(k) pathway — is a qualitative in vitro diagnostic test for real-time polymerase chain reaction on the Rotor-Gene Q MDx instrument (Qiagen) to detect the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood.

As HemOnc Today previously reported, the test previously received marketing authorization for detection of mutations affecting the JAK2 gene among patients with suspected polycythemia vera.

The FDA clearance now includes indications for detection of essential thrombocythemia and primary myelofibrosis. The test is intended to be used in conjunction with other factors to evaluate suspected myeloproliferative neoplasms.

“We are eager to expand the use of our ipsogen JAK2 assay, which is already available in Europe and other markets, for use in a wider range of patients in the U.S.,” Thierry Bernard, senior vice president and head of Qiagen’s Molecular Diagnostics Business Area. “Our JAK2 assay makes it easier for hematologists and oncologists to follow recommended diagnostic testing algorithms and international guidelines for their patients suspected of having [myeloproliferative neoplasms].”