DNAnexus to Develop Platform for FDA Evaluation of NGS-Based Diagnostics

The Food and Drug Administration’s (FDA) Office of Health Informatics has awarded a research and development contract to DNAnexus to develop precisionFDA, an open source platform for community sharing of genomic information. PrecisionFDA is intended to be a new approach for evaluating bioinformatics workflows, and will be an integral part of the agency’s work to understand diagnostic tests that incorporate next-generation sequencing (NGS) technologies.

FDA’s role under the White House’s Precision Medicine Initiative is to review the current regulatory landscape and develop a streamlined approach to evaluating NGS-based diagnostics. PrecisionFDA is being created to offer test innovators a flexible method for independently evaluating the accuracy and reproducibility of NGS analysis workflows, and to securely share results with collaborators and FDA. PrecisionFDA will also support community efforts to crowdsource reference datasets, addressing the critical need for convenient, reproducible comparisons between results derived from the same biospecimen.

DNAnexus expects that the platform will be broadly used by NGS-based test providers, standards-making bodies, pharmaceutical and biotechnology companies, healthcare providers, academic medical centers, research consortia, and patient advocacy groups.

FDA Draft Guidance Outlines Standards for HPV Tests Used in Cervical Cancer Screening

The Food and Drug Administration (FDA) has released draft guidance intended to help medtech companies design studies on the effectiveness of human papillomavirus (HPV) tests. These tests are used as aids in screening for cervical cancer or as first-line primary cervical cancer screening devices. Because cervical cancer screening is recommended for virtually all sexually active women and a substantial number of these women will be tested for HPV, the potential for harm to public health from false-negative or false-positive HPV results is significant. Therefore, establishing the performance of these devices and understanding the risks that might be associated with them is critical to patient safety.

The draft guidance encompasses tests that detect a group of HPV genotypes, such as particularly high risk HPVs, as well as devices that detect more than one genotype of HPV and further differentiate among them to indicate which genotype is present. The document specifically deals with devices that qualitatively detect HPV nucleic acid from cervical specimens, but many of the recommendations will also be applicable to devices that detect HPV proteins.

FDA is seeking suggestions on this draft document until November 12. Electronic comments may be submitted at www.regulations.gov.

NowDiagnostics Gets FDA Nod for POC Blood Test for Pregnancy

The Food and Drug Administration (FDA) has cleared NowDiagnostics’ AdexusDx hCG point-of-care (POC) test for pregnancy, making it the first single-step, capillary blood test for human chorionic gonadotropin (hCG) requiring no equipment to receive 510(k) clearance. Depending on the woman and her pregnancy, AdexusDx diagnoses pregnancy approximately 2 to 8 days earlier than commonly available urine-based tests using a single drop of capillary or whole blood. Early detection of pregnancy is important so that caregivers can avoid prescribing certain medications and procedures that could harm a fetus. Studies show, however, that many of the most widely used POC hCG urine-based devices are susceptible to false-negative results. NowDiagnostics intends AdexusDx to serve as a more reliable alternative to these tests.

AdexusDx also detects hCG in plasma or serum, and can be used by healthcare professionals in a variety of clinical and critical care settings, providing results in 10 minutes.

FDA Clears Ortho’s Automated Analyzer for Transfusion Labs

Ortho Clinical Diagnostics has obtained 510(k) clearance from the Food and Drug Administration (FDA) for the Ortho Vision Analyzer, an interactive, fully automated instrument for transfusion medicine laboratories. This analyzer is intended to help improve the safety of blood transfusions by reducing the lab’s reliance on manual methods and offering labs an automated solution that can anticipate and respond to individual user needs and demands. With secure monitoring technologies for safety checks and balances, the Ortho Vision Analyzer gives transfusion medicine professionals the ability to track critical steps in the immunohematology testing process. The analyzer also verifies and documents diagnostic checks throughout the testing process using Ortho’s proprietary Intellicheck technology, while the company’s e-Connectivity technology provides 24/7 remote data tracking that monitors instrument performance. Laboratory personnel can also login to the system from any location and at any time in order to collaborate on interpreting results in real time.

FDA OKs bioMérieux’s New Immunoassay Platform

BioMérieux has received clearance from the Food and Drug Administration (FDA) for the Vidas 3 analyzer, a low-throughput immunoassay platform. This instrument expands the offering of the Vidas immunoassay product range, which includes Vidas and mini Vidas, and uses the same reagents as these older generation analyzers. The analyzer can perform tests on demand, either individually or in series, and features enhanced automation, improved traceability, and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. Its design makes it suited to central as well as satellite labs, and in particular, it is adapted to meet the needs of labs supporting emergency departments and critical care. Currently, the Vidas 3 menu features specialty and high value medical tests, such as Vidas BRAHMS PCT to assist in managing septic patients. Vidas 3 is also CE marked and registered with the Chinese FDA, making it available to clinical labs on a global scale.

Trichomonas Nucleic Acid Assays Classified by FDA as Class II With Special Controls

Any company applying for 510(k) clearance for a Trichomonas vaginalis nucleic acid assay will now need to comply with the special controls named in a final classification administrative order recently issued by the Food and Drug Administration (FDA). FDA defines a Trichomonas vaginalis nucleic acid assay as a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens. This final order builds on a precedent set in 2011 when FDA classified Gen-Probe’s Aptima Trichomonas vaginalis assay as class II with special controls. The agency believes that these special controls, set forth in the document “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis,” are necessary in addition to general controls to mitigate the potential health risks that this type of assay may pose.