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MDx/CDx Focus: FDA Clears Sequenom IMPACT Dx; Agency Accepts AbbVie HCV Regimen NDA; and More


FDA Clears Sequenom's IMPACT Dx to Aid Thrombophilia Diagnosis

The US Food and Drug Administration this week cleared Sequenom's IMPACT Dx Factor V Leiden and Factor II genotyping test.

Agena Bioscience recently acquired Sequenom's bioscience business. IMPACT Dx is indicated as a tool that doctors can use to test patients they suspect of having thrombophilia.

People with one copy of the Factor V Leiden mutation have a seven-fold greater risk of experiencing venous thromboembolism; the risk balloons to 80-fold greater for those carrying two copies of the mutation. Those heterozygous for the Factor II prothrombin mutation have a 2.8-fold increase of venous thromboembolism.

Agena plans to launch the test in Europe with CE self certification.

The IMPACT test uses matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry to analyze nucleic acids.

"The IMPACT Dx System is designed for use with FDA-cleared or approved tests citing its use," Sequenom said in a statement. "Additional tests will be added to the menu over time."

FDA Accepts AbbVie's NDA for Investigational HCV Genotype 1 Regimen

The FDA has accepted AbbVie's new drug application for its investigational drug for treatment of adults chronically infected with the genotype 1 hepatitis C virus. The agency has also granted the HCV drug breath through designation and agreed to review it under priority review.

AbbVie submitted its NDA for the interferon-free, oral drug on April 21, which included data from six Phase III studies involving more than 2,300 genotype 1 HCV patients across 25 countries.

The investigational regimen includes ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without RBV. According to the company, the combination of these three drugs throws a wrench in the virus' ability to replicate and enables a sustained virologic response across population.

The sponsor has also submitted a marketing authorization application for the drug in the EU.

Clovis Enrolls First Patient In Rucaparib Phase II Study

Clovis Oncology has enrolled and dosed the first patient into the Rucaparib Assessment in BRCA-mutated Pancreatic Cancer, or RUCAPANC, study. The Phase II trial is investigating the efficacy and safety of Clovis' PARP inhibitor rucaparib as a treatment for pancreatic and platinum-sensitive ovarian cancer.

Noting that most drug makers are studying PARP inhibitors in ovarian and breast cancers, Clovis highlighted that RUCAPANC will explore rucaparib's activity in hard-to-treat pancreatic cancer patients.

"New options for the treatment of advanced pancreatic cancer are needed, and we believe there is potential for an accelerated submission path should the data from this study support it," Clovis Oncology CEO Patrick Mahaffy said in a statement.

Past studies have shown "a few notable responses" to rucaparib therapy from pancreatic cancer patients with BRCA2 mutations. Two patients experienced progression-free survival of 7.5 and 5.9 months on the drug and didn't have significant adverse events.

In RUCAPANC, researchers will enroll 100 previously treated pancreatic cancer patients with germline or somatic BRCA mutations, who will receive rucaparib at 600 mg twice a day. The primary study endpoint of the RUCAPANC is overall response rate, and secondary endpoints are duration of response, progression-free survival, overall survival, and safety.