FDA Watch: Agency Approves New STD Screening Assay Applications
From - Laboratory Industry Report The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the… . . . read more
The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the throat and rectum. The tests, including the Aptima Combo 2 from Hologic and the Cepheid Xpert CT/NG had previously been cleared only for testing urine, vaginal and endocervical samples. According to Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, “the tests will fill an unmet public health need by allowing for more screening.”
Other New FDA Approvals
Here’s a look at the other key FDA approvals announced from mid-April through the third week in May, 2019:
| NEW FDA APPROVALS | ||
| Manufacturer(s) | Product(s) | |
| Hologic | Clearance for Aptima Combo 2 for extragenital indications for chlamydia and gonorrhea testing | |
| Cepheid | Clearance for Xpert CT/NG for extragenital indications for chlamydia and gonorrhea testing | |
| Cepheid | Clearance for incorporating enhanced algorithms into a definition file used in determining a number for test results — specifically results that are Staphylococcus aureus (SA) positive, methicillin-resistant Staphylococcus aureus (MRSA) positive, SA negative and MRSA negative | |
| Microbiologics | Clearance for the Cepheid Xpert C. difficile/Epi Control Panel for use as external assayed positive and negative quality controls to monitor performance of in vitro nucleic acid testing procedures | |
| Roche | 510(k) clearance for Cobas TV/MG test for detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA | |
| Roche | Clearance for Elecsys TSH electrochemiluminescence immunoassay for diagnosing thyroid and pituitary disorders while running on Cobas e immunoassay analyzer | |
| Clever Culture Systems | 510(k) clearance for APAS Independence instrument and associated urine analysis module for culture-plate screening and interpretation | |
| Qiagen | 510(k) clearance for QiaStat-Dx syndromic testing system and multiplex respiratory pathogen panel | |
| GenePOC | Clearance for small molecular diagnostic panel test to detect carbapenem drug resistance run on the GenePOC Revogene system | |
| Grail | Breakthrough device designation for lead multi-cancer detecting blood test | |
| Sekisui Diagnostics | Clearance for Sekure Creatine Kinase Assay to measure creatine kinase activity in serum and plasma on firm’s SK500 clinical chemistry system | |
| IXensor | Clearance for PixoTest POCT System to monitor long-term glycemic control in patients previously diagnosed with diabetes mellitus | |
| Beckman Coulter | Clearance for MicroScan Dried Gram-Negative MIC/Combo Panel to determine antimicrobial agent susceptibility of colonies grown on solid media of aerobic and facultative anaerobic gram-negative bacilli | |
| Natera | Breakthrough device designation for test to detect and quantify circulating tumor DNA (ctDNA) after surgery in blood of patients already diagnosed with some types of cancer and combined with certain drugs | |
| Turning Point Therapeutics + Almac Diagnostic Services | Investigational device exemption for use of an Almac NGS assay for use in identifying patients with ROS1, NTRK1-3, and ALK gene fusions in advanced solid tumors to determine if cancer patients are eligible to enroll in a Phase II clinical study | |
| RenalytixAI | Breakthrough device designation for KidneyIntelX AI-powered diagnostic for kidney disease | |
| Caris Life Sciences | Breakthrough Device designation for MI Transcriptome companion diagnostic assay | |
| InDevR | 510(k) clearance for FluChip-8G Influenza A+B assay | |
New CE Marks & Global Certifications
Notable European CE certifications during the period:
| NEW CE MARKINGS IN EUROPE | ||
| Manufacturer(s) | Product(s) | |
| DiaSorin Molecular | CE marking for its Simplexa HSV 1/2 & VZV Universal Direct MDx assay for use on firm’s Liaison MDx instrument | |
| Roche | CE-IVD marking for Cobas MTB-RIF/INH test to detect mutations associated with resistance to antibiotics rifampicin and isoniazid within tuberculosis DNA | |
| Beckman Coulter | CE marking for DxA 5000 system total laboratory automation solution | |
| Quotient | CE marking for first immunohematology (IH) microarray designed to run on its MosaiQ high-throughput automated testing platform | |
| Binx Health | CE marking for chlamydia and gonorrhea (CT/NG) test run on its Binx io point-of-care platform | |
| Epic Sciences | CE-IVD marking for liquid biopsy test collection kit | |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
| SpeeDx | Australia | Therapeutic Goods Administration approval for PlexPCR RespiVirus test |
| Beckman Coulter | China | Chinese National Medical Products Administration approval for DxA 5000 system total laboratory automation solution |
| Abbott | Developing countries | World Health Organization prequalification approval for m-Pima HIV-1/2 VL viral load diagnostic test, a portable molecular point-of-care platform for use in resource-limited settings such as in sub-Saharan Africa |
| Immucor | Canada | Health Canada approval for NEO Iris mid- to high-volume automated immunohematology instrument |
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