FDA Watch: Personalized Medicine Approvals Continue to Flow

After a slow start to the year, new product business picked up significantly in the past four weeks. Here’s a rundown of the key diagnostic product launches from mid-January through late February.

Record Year for Personalized Medicine Approvals
First, the big picture. In 2017, the FDA approved 16 new personalized medicine products, 34% of all new of all new drugs, agents, or therapeutic biologics approved during the year, reports the Personalized Medicine Coalition (PMC). Key approvals included:

  • Expanded approval of Keytruda to all tumor types, the first approval of an oncology drug based on a biomarker rather than location in the body;
  • The first approval of DTC marketing of health-related genetic tests— 23andMe’s Personal Genome Service Genetic Health Risk tests;
  • Approval of personalized medicine biosimilar for Herceptin (trastuzumab); and
  • Joint FDA approval and CMS coverage decision for Foundation Medicine’s NGS-based FoundationOne CDx test.

A Blood Test Breakthrough
Continuing the new approval momentum, on Valentine’s Day, the FDA announced a new milestone: the first agency approval of a blood test for use in diagnosing concussions. The Brain Trauma Indicator, marketed by Banyan Biomarkers Inc., measures two proteins associated with concussion when detected in high levels via CT scan. The new assay is blood-based and has been approved for use by physicians in ruling out concussion. Abbott is among the other firms reported to be developing their own blood test for detecting the proteins without CT scan.

Flu Tests
Meanwhile, as the U.S. struggles with its nastiest flu season in years, the FDA approved five different products for the qualitative detection of influenza, including:

  • QuickVue Influenza A+B, an assay from Quidel that detects and differentiates between influenza types A and B in 10 minutes, which the agency reclassified as a class II rapid influenza diagnostic test;
  • Two different rapid, instrument influenza detection and A vs. B differentiation tests from Alere, now part of Abbot;
  • Xpert Xpress Flu, Cepheid’s new test system and molecular test for detecting A and B influenza from either nasopharyngeal or nasal swabs; and
  • Mesa Biotech’s Accula Flu A/Flu B test which runs on the firm’s Accula system.

Other New FDA Approvals
Meanwhile, here’s a rundown of the other key new FDA approvals announced from mid-January through late February:

Manufacturer(s) Product(s)
Guardant Health Expedited access pathway designation for Guardant360 liquid biopsy assay
Banyan Biomarkers Inc. Brain Trauma Indicator, first blood test approved for diagnosing concussion
Quidel QuickVue Influenza A+B assay to detect and differentiate influenza types A and B, approved after being reclassified as a class II rapid influenza diagnostic test
Roche Approval of multiplex Factor II and Factor V test which does real-time PCR analysis for mid- to high-volume labs, for use on Cobas 4800 system
Becton Dickinson Approval of automated BD Onclarity HPV molecular test to detect 14 types of high-risk human papilloma virus from specimens collected in the BD SurePath liquid-based cytology vial for cervical cancer screening
Becton Dickinson Approval of Phoenix automated microbiology system for in vitro quantitative determination of antimicrobial susceptibility
Vela Diagnostics Approval of Sentosa SA201 HSV-1/2 PCR herpes simplex virus test detecting viral DNA from oral or anal skin lesions
Alere Approval of Alere i Influenza A & B for qualitative detection and differentiation of influenza A and influenza B in patients with respiratory infection symptoms
Alere Approval of Alere i Influenza A & B 2, rapid, instrument-based isothermal test for qualitative detection and differentiation of influenza A and influenza B in patients with respiratory infection symptoms
Alere Approval of Alere i Strep A, rapid, instrument-based isothermal test for qualitative detection of Group A Strep from throat swab specimen
Alere Approval of Alere i RSV, rapid, instrument-based isothermal test for qualitative detection and differentiation of respiratory syncytial virus viral RNA in patients with respiratory infection symptoms
Cepheid Approval of Xpert Carba-R Assay, automated real-time PCR diagnostic test for qualitative detection of gene sequences from rectal or perirectal swab specimens or isolates of pure cultures of gram-negative bacteria that are not susceptible to carbapenem
Cepheid Approval and CLIA waiver for Xpert Xpress Flu test used in near-patient settings to detect both A and B strains of influenza from either nasopharyngeal or nasal swabs
Techlab Approval of Campylobacter Chek test for detecting campylobacteriosis
Techlab Approval of Campylobacter Quik Chek test for detecting campylobacteriosis
Myriad Genetics Expanded approval of BRACAnalysis CDx test for identifying breast cancer patients with germline BRCA mutations and who are thus most likely to benefit from Lynparza
Inova Diagnostics Approval of Quanta Flash Calprotectin assay for detection of fecal calprotectin in human stool samples
Mesa Biotech Approval and CLIA waiver for Accula Flu A/Flu B test to detect and distinguish influenza A and B from nasal swab specimens
Siemens Healthineers Approval of blood urea nitrogen (BUN) and total carbon dioxide (TCO2) point-of-care tests to diagnose kidney diseases and metabolic imbalances run on firm’s handheld Epoc blood analysis system
Meso Scale Diagnostic Approval of conventional C-reactive protein assay, based on firm’s Multi-Array technology
Sebia Approval of Hydrashift 2/4 daratumumab assay for evaluating multiple myeloma patients treated with Darzalex
Hologic Approval of Aptima HBV Quant Assay for quantitation of hepatitis B viral load on firm’s Panther system
Qiagen Expanded approval of Ipsogen JAK2 RGQ PCR Kit to diagnosis of all myeloproliferative neoplasms
Qiagen Extended indications for use of firm’s Therascreen EGFR RGQ PCR kit to guide the use of Boehringer Ingelheim’s Gilotrif (afatanib) for first-line treatment of patients with metastatic non-small cell lung cancer harboring non-resistant EGFR mutations
Bio-Rad Laboratories Approval of IH-Incubator L and IH-Centrifuge L instruments for use with firm’s IH-System Gel Reagents for manual blood typing
Diazyme Laboratories Approval of fully automated two-reagent EZ Vitamin D assay for use on validated clinical chemistry analyzers

During the period, the following FDA CLIA waivers were announced:

Manufacturer(s) Product(s)
ACON Laboratories Inc. Mission Cholesterol Pro Monitoring System {Mission Cholesterol Pro Test Cartridges}
Cepheid Xpert Xpress Flu test
Mesa Biotech Accula Flu A/Flu B

New CE Marks & Global Certifications
Notable European CE certifications:

Manufacturer(s) Product(s)
Qiagen Approval of Therascreen PITX2 RGQ PCR kit
Sophia Genetics Approval of molecular diagnostics test to detect leukemia and other hematological diseases
GenDx Approval of chimerism monitoring products for use in stem cell or bone marrow transplantation
Roche Approval of Cobas TV/MG test for use on Cobas 6800/8800 systems
Mesa Biotech Approval of PCR point-of-care infectious disease testing platform

Other international clearances announced in the past month:

Manufacturer(s) Country(ies) Product(s)
Thermo Fisher Scientific Canada Class III Medical Device System License to firm’s BRAHMS business for four automated immunofluorescent assays used as prenatal screening aids
Siemens Healthineers Canada Approval to market its Symbia Intevo Bold SPECT/CT system
Premaitha Health Brazil Approval of Iona noninvasive prenatal test as in vitro diagnostic
Qiagen Japan Approval of QuantiFeron-TB Gold Plus (QFT-Plus) as in vitro diagnostic to detect tuberculosis infection
Amoy Diagnostics China Approval of SuperARMS EGFR mutation analysis test as companion diagnostic for EGFR TKI-based non-small cell lung cancer drugs
NGeneBio South Korea Approval of BRCAaccuTest for clinical use
GenDx South Korea Approval of NGSgo human leukocyte antigen typing workflow for use in transplant medicine
Curetis Singapore Approval of Unyvero test cartridge for diagnosing pneumonia in hospital patients
Vela Diagnostics Singapore Approval of Real-Time PCR-based Sentosa SA ZIKV RT-PCR Test for in vitro diagnostic use

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