CLN Article

Regulatory Roundup

First Non-Invasive DNA Screening Test for Colon Cancer Approved by FDA
The Food and Drug Administration (FDA) has approved Exact Sciences’ Cologuard, the first non-invasive test that screens for colorectal cancer by both analyzing DNA and detecting red blood cells in stool samples.

The Centers for Disease Control and Prevention estimates that if everyone age 50 or older had regular screening tests, at least 60 percent of colorectal cancer deaths could be avoided. However, an estimated 23 million Americans between the ages of 50 and 75 do not get screened as recommended. As a result, colorectal cancer remains the second leading cause of cancer-related death in the U.S. among cancers that affect both men and women.

After a physician orders Cologuard, the kit is mailed directly to the patient’s home, a feature of the test that is intended to increase screening compliance rates. The patient then collects a stool sample in the Cologuard Collection Kit and sends the kit back to the Exact Sciences lab for testing.

At the lab, the stool sample is analyzed for hemoglobin as well as for mutations associated with colorectal cancer that are found in the DNA of cells shed by precancerous polyps. In clinical trials, this method detected 92% of colorectal cancers and 42% of precancerous polyps in the study population, versus fecal immunochemical testing (FIT), which detected 74% of cancers and 24% of precancerous polyps. Cologuard was less accurate than FIT, however, at correctly identifying subjects negative for colorectal cancer or precancerous polyps.

In addition to being the first DNA test approved for colorectal cancer screening, Cologuard is also the first product reviewed through a pilot program that allows FDA and the Centers for Medicare and Medicaid Services (CMS) to concurrently review medical devices to help reduce the time between FDA’s approval of a device and Medicare coverage. As a result, CMS has already issued a proposed national coverage determination for Cologuard.

FDA Approves First ZnT8 Autoantibody Test for the Diagnosis of Type 1 Diabetes
Kronus has received authorization from FDA to market its Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA assay, making this the first ZnT8Ab test approved to help distinguish patients with type 1 diabetes from those with other types. People with type 1 diabetes produce little or no insulin because their immune system attacks and destroys the cells in the pancreas that produce this hormone. As a result, the immune system of many people with type 1 diabetes produces ZnT8Ab, while the immune system of patients with type 2 and gestational diabetes does not. Kronus’s assay aids the diagnosis of type 1 diabetes by detecting the presence of the ZnT8 autoantibody in a patient’s blood. In clinical trials, the test was able to detect this autoantibody in 65% of patients with diagnosed type 1 diabetes, while giving a false-positive result in less than 2% of the samples from patients diagnosed with other kinds of diabetes, other autoimmune diseases, and other clinical conditions.

CMS Approves Update to A2LA’s CLIA Accreditation Program
The American Association for Laboratory Accreditation (A2LA) announced that the Centers for Medicare and Medicaid Services (CMS) has approved an update to its program for the accreditation of clinical laboratories performing waived testing.

Such testing will now be held to the CLIA waived testing requirements. Additionally, A2LA has chosen to adopt as requirements the guidelines published by the Centers for Disease Control and Prevention (CS242576-A) related to waived testing. A2LA does not accredit laboratories that perform waived testing exclusively, and those laboratories that perform non-waived testing in addition to waived testing are eligible for A2LA accreditation.

In May 2014, A2LA became the first organization since 1995 to be recognized by CMS to accredit clinical laboratories (for all specialties and sub-specialties) to the requirements contained within CLIA. This makes A2LA the only U.S. accreditation body with dual recognition from CMS for its CLIA accreditation program as well as from the International Laboratory Accreditation Cooperation for the accreditation of clinical laboratories to ISO 15189:2012.

FDA Clears BD’s Automated Chlamydia and Gonorrhea DNA Tests

BD Diagnostics has received 510(k) clearance from FDA for the BD ProbeTec Chlamydia trachomatis Qx Amplified DNA assay and the BD ProbeTec Neisseria gonorrhoeae Qx Amplified DNA assay on the BD Viper LT system. The BD Viper LT system is a bench-top molecular platform that automates sample liquid handling, nucleic acid extraction, amplification, detection, and result reporting without the need for user intervention. This platform is also designed to manage primary sample tubes with pierceable caps and ready-to-use reagents. When performed on the BD Viper LT system, the BD ProbeTec Qx assays use BD proprietary ferric oxide, ferric oxide DNA extraction, and strand displacement amplification technologies for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA. These tests are indicated for use with asymptomatic and symptomatic individuals, and can be performed on all genital sample types: clinician-­collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), male and female urine specimens (neat and stored in urine preservative transport), and gynecological specimens collected in BD SurePath Preservative Fluid or PreservCyt Solution.

Quidel Receives FDA Nod for Handheld Group A Strep Test
FDA has cleared Quidel Corpora­tion’s AmpliVue GAS assay for the qualitative detection of group A β-hemolytic streptococcus (Strep­tococcus pyogenes) nucleic acids in patients with signs and symptoms of pharyngitis, such as sore throat. Group A streptococci are responsible for several illnesses, ranging from mild strep throat or skin infections, to severe diseases such as necrotizing fasciitis or streptococcal toxic shock syndrome. The AmpliVue GAS assay is a handheld, disposable test that detects these bacteria using throat swab specimens, and generates results in less than an hour. This assay does not require culture confirmation of negative results, upfront extraction of DNA, or the use of thermocycler equipment.

The GAS assay is Quidel’s fourth molecular infectious diseases test to receive 510(k) clearance from FDA in the handheld, disposable AmpliVue format. On the AmpliVue platform, Quidel also offers tests for the diagnosis of Clostridium difficile, group B strep, herpes simplex virus 1, and herpes simplex virus 2.

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