CLN Article

Regulatory Roundup

FDA Requests Proof From Pathway Genomics That Its Liquid Biopsy Works

The Food and Drug Administration (FDA) has sent a letter to Pathway Genomics, the provider of a controversial liquid biopsy test, stating that the agency believes the test is high-risk, has not received adequate clinical validation, and may harm the public health. A San Diego-based startup, Pathway Genomics launched its test, CancerIntercept, less than 2 weeks prior to receipt of FDA’s notice and without authorization from the agency to market it.

Pathway Genomics claims that by analyzing tumor DNA shed into the bloodstream, the test detects mutations commonly associated with lung, breast, ovarian, colorectal cancers, and melanoma, as well as mutations that occur less frequently in other cancer types (such as pancreatic, head and neck, thyroid, gastric, and prostate cancer). Patients can initiate testing with CancerIntercept through their treating physician or they can have a sample collection kit shipped to their home after Pathway Genomics’ online physician network reviews their request.

In FDA’s letter, however, the agency states that the information on the company’s website about the test’s performance is not sufficient to show that the test detects cancer early in high-risk individuals. The letter goes on to request that Pathway Genomics contact the agency to discuss the studies the company has conducted to support its expansive claims of screening for up to 10 different cancers. Though Pathway Genomics is considering FDA’s concerns, the company says it believes CancerIntercept is a laboratory-developed test and that the validation of the test it has performed is therefore appropriate.

Nanosphere Receives FDA Nod for Novel Flexible Respiratory Panel

The Food and Drug Administration has granted 510(k) clearance to Nanosphere for its Verigene Respiratory Pathogens Flex (RP Flex) nucleic acid test. This test features Nanosphere’s novel Flex software, which enables the 16 viral and bacterial targets identified by RP Flex to be reported as a full multiplex panel or in various user-defined subsets. Labs then only need to pay for the targets ordered for each patient sample. Because the demand and need for respiratory pathogen testing varies by season, geography, epidemiology, and patient demographics, labs need the flexibility to choose and pay for only the microbial targets applicable to a given patient. RP Flex is the first respiratory test that provides this adaptability, and Nanosphere believes it will enable labs to practice better test stewardship and reduce healthcare costs. The test is designed to run on the automated sample-to-result Verigene System, which uses Nanosphere’s core proprietary gold nanoparticle chemistry and detects infectious pathogens and drug resistance markers by targeting conserved genetic regions of a bacterium or virus.

Analytik Jena Receives CE Mark for Molecular Hepatitis Delta Virus Test

Analytik Jena AG is the world’s first company to receive CE-IVD certification for a molecular diagnostic kit that quantifies hepatitis delta virus (HDV) RNA, reaching a milestone in the standardization of HDV nucleic acid amplification tests. Hepatitis delta is viewed as one of the most severe forms of viral hepatitis infection. Solely connected to a coexisting hepatitis B virus infection, it very frequently leads to chronic cirrhosis of the liver in cases of superinfection. Analytik Jena’s test for this disease, called the RoboGene HDV RNA Quantification Kit 2.0, uses quantitative real-time polymerase chain reaction. This is considered the method of choice for the confirmation of an existing HDV infection and for antiviral therapy monitoring due to its range of sensitivity from 5 to 25 IU/mL. The kit joins the Jena, Germany-based company’s existing menu of diagnostics for hepatitis B and C.

FDA OKs BD Panel That Detects Intestinal Parasites

BD Life Sciences has earned Food and Drug Administration clearance for its BD Max Enteric Parasite panel for use on the BD Max system. This panel is a qualitative test that detects DNA from the intestinal parasites Giardia lamblia, Cryptosporidium (C. hominis and C. parvum), and Entamoeba histolytica in both unpreserved and 10% formalin-fixed stool specimens. Cases of gastroenteritis caused by the parasites Giardia and Cryptosporidia, while relatively common, may be subject to under-diagnosis and reporting in the U.S. The Enteric Parasite panel is the latest in the BD Max Enteric suite of assays that aid in the diagnosis of infectious gastroenteritis. It joins the BD Max Enteric Bacterial panel, which detects the pathogens that are responsible for up to 95% of the bacteria causing gastroenteritis. When paired together, the two panels give labs the ability to detect the majority of pathogens causing gastroenteritis with a fully automated, rapid platform.

Roche Gets FDA CLIA Waiver for Flu Test

The Food and Drug Administration has granted Roche CLIA waiver for the cobas Influenza A/B test, making it available for use in non-traditional testing sites, including physician offices, emergency rooms, health department clinics, and pharmacy clinics. Designed for use on the fully-automated cobas Liat system, the assay is the first CLIA-waived, real-time polymerase chain reaction test to detect influenza A and B in approximately 20 minutes. It differentiates between the RNA of both viruses and also targets highly conserved regions of their genomes to provide broad coverage of more than 30 commonly found strains of influenza A and B. Additionally,the test detects viruses in patients with low viral load, an issue that can pose challenges in some adults with influenza infection. The cobas Influenza A/B test is the second assay on the cobas Liat system to receive CLIA waiver, following the cobas Strep A test, which received CLIA waiver in May 2015.

FDA Clears Focus Diagnostics to Add Genital Swab Claim to Molecular HSV Test

Focus Diagnostics, the products business of Quest Diagnostics, has received 510(k) clearance from the Food and Drug Administration (FDA) to add a genital swab claim to its Simplexa HSV 1 & 2 Direct molecular test. The new labeling clearance follows FDA’s de novo 510(k) clearance and CLIA moderate complexity categorization of the Simplexa HSV 1 & 2 Direct molecular test in March 2014. At that time, FDA cleared the test for use with cerebrospinal fluid from patients suspected of herpes simplex virus (HSV) central nervous system infection, including encephalitis, which can be caused by infection with HSV 1 or 2. The added genital swab claim broadens the test’s potential clinical utility as an aid in diagnosing infection with one or both HSVs. Like other Simplexa Direct tests, the Simplexa HSV 1 & 2 is designed for use on the 3M Integrated Cycler, which employs real-time polymerase chain reaction technology to detect DNA or RNA in viruses, bacteria, and other analytes.