July 2010 Clinical Laboratory News: News from the FDA

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July 2010: Volume 36, Number 7

Group B Strep Assay Cleared

BD Diagnostics announced that FDA has cleared its BD MAX GBS Assay for Group B Streptococcus on the BD MAX system, an automated workstation for molecular testing. The system is designed to streamline workflow and offer full walkaway automation to accommodate varying workloads for maximum lab efficiency and flexibility.

The assay represents a “significant advance” in neonatal healthcare by streamlining the Group B Streptococcus screening process and addressing the limitations of culture methods, according to a statement issued by the company. The current standard for preventing Group B Streptococcus is to screen women at 35-37 weeks gestation using culture methods, which can be limited by sensitivity, turnaround time, and the need for highly trained technologists to interpret the results.

In contrast, the BD MAX GBS assay identifies Group B Streptococcus in just over an hour from Lim broth. In addition, by automating sample lysis through polymerase chain reaction detection, the BD MAX System “offers walkaway convenience for up to 24 samples in approximately two-and-a-half hours,” the company indicated.

Roche Dual-PCR Target HIV-1 Test Approved

Roche Molecular Diagnostics announced that FDA approved its new dual-polymerase chain reaction target HIV-1 viral load test to quantify the amount of virus in a patient’s blood. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test is the first quantitative viral load test to amplify and detect two separate regions of a target genome.

The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test detects HIV-1 RNA (Group M and O) down to 20 copies per milliliter in EDTA plasma. The test is designed for use in HIV-1 infected patients and can be used to assess patient progress and monitor the effects of antiretroviral therapy by measuring baseline HIV-1 RNA levels and changes in EDTA plasma HIV-1 RNA levels during antiretroviral treatment.

FDA Questions Pathway Genomics Kit Status

Pathway Genomics had no sooner announced in May that Walgreens would begin selling its Genetic Health Report, a home-use saliva collection kit, than Walgreens announced it would not sell the kits after all and FDA sent a letter to Pathway Genomics seeking clarification about clearance or approval for the kit.

The San Diego-based genetic test provider had planned to offer the kits at Walgreens nation-wide, except in New York State, which restricts direct-to-consumer gene tests. Customers would have paid $30 at Walgreens for saliva collection vials and $79–$249 more online for a genetic analysis. Consumers would then receive a Genetic Health Report, which provides pharmacogenetic information for certain drugs, carrier status for conditions like cystic fibrosis, and the likelihood of developing numerous diseases such as Alzheimer’s, breast cancer, colorectal cancer, and diabetes.

In its letter, which was posted online, FDA asked Pathway to provide a clearance or approval number for the test or evidence that the test does not require FDA approval or clearance. “The Genetic Health Report appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act,” wrote James Woods, deputy director of patient safety and product quality in the agency’s Office of In Vitro Diagnostic Device Evaluation and Safety. In light of FDA’s questions, Walgreens tabled plans to sell the kits.

In a statement on its website, Pathway emphasized that the company operates a CLIA-certified lab and is in compliance with currently applicable regulations and guidelines for its lab and services. “The field of genetics and personalized genetic testing is a relatively new science that has developed rapidly over the last several years under limited FDA oversight. During that same time there has been a robust conversation between scientists and experts from the genetics industry, the FDA, and Congress about whether updated regulations are needed, and the appropriate role that government should have in oversight of this new science,” the statement continued. “We share the responsibility with Congress and the FDA to ensure public safety. We look forward to working collaboratively with them as any new regulations or guidelines are considered for developing public health policy.”

FDA Clears Molecular Test for S. aureus, MRSA

Cepheid announced that FDA cleared the company’s Xpert SA Nasal Complete, the first and only molecular test designed to simultaneously detect and differentiate both Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus in less than 1 hour. The test runs on Cepheid’s GeneXpert System, a closed, self-contained, fully-integrated and automated platform that combines on-board sample preparation with real-time polymerase chain reaction amplification and detection functions.

More than 90% of hospital-acquired S. aureus infections originate from patients’ own flora, making S. aureus nasal carriers about nine times more likely than non-carriers to develop surgical site infections. Harboring the bacterium in the nasal cavity also is a major self-infection factor among dialysis, intensive care, and burn patients. The test will enable physicians to target appropriate prophylactic therapy and decolonization in at-risk patients, according to a company statement.

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