FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials

Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final guidance allowing companies to submit for simultaneous review for the clinical trial.

The New Streamlined Process

The new streamlined process is optional but the FDA “encourages sponsors to use it. . . when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory approval.” the agency said in its final guidance. Sponsors submit to the Center for Devices and Radiological Health (CDER) or Center for Biologics Evaluation and Research (CBER) all information about the oncology codevelopment program (including information about the investigational IVD) in the trial protocol for the investigational new drug application (IND).

One sponsor should take the lead in communicating with FDA about the IND. To indicate its intent to use the streamlined process, the sponsor should include the text “Streamlined IVD SRD” in either:

  • In Section 11 (under “Other”) of the Form FDA 1571, Investigational New Drug Application; or
  • The cover letter it submits with the IND (along with a reference to which section(s) of the electronic common technical document contains relevant information).

The final guidance also lists the additional information about the IVD and how it will be used in the trial that the sponsor should list in the protocol it submits for the IND, including:

  • A description of the device;
  • How the results from the investigational IVD will be applied in the clinical trial;
  • A description of the population and information regarding what is known about the prevalence of the biomarker (evaluated by the investigational IVD) in the patient population;
  • The specimen type that will be collected for investigational IVD testing (including the anatomical site) and whether any biopsy conducted exclusively for investigational IVD testing could present a potential for serious risk to the health, safety or welfare of the subject.

By signing Form FDA 1571 (section 17) sponsors provide assurance of an institutional review board review of the complete clinical trial protocol and activities for the investigational IVD and the investigational drug, the final guidance specifies.

The CBER or CDER will then use the information to determine as part of the IND review and within the 30-day review period whether use of the IVD is significant risk (SR), nonsignificant risk (NSR) or exempt from investigational device exemption (IDE) requirements.

Determination Consequence
NSR CBER or CDER confirms determination in appendix to Study May Proceed Letter + reminds sponsor to follow NSR procedures in obtaining biopsies for testing + submit unanticipated adverse device effect reports to IND
SR CBER or CDER confirms determination in appendix to Study May Proceed Letter + asks sponsor to submit IDE application to CBER or Center for Devices and Radiological Health (CDRH) + not start trial until after IDE is approved
Exempt CBER or CDER confirms determination in appendix to Study May Proceed Letter

New FDA Approvals

Here’s a look at other new product approvals announced from late September through late October:


Manufacturer(s) Product(s)
Ortho Clinical Diagnostics Clearance for Ortho Sera suite of reagents that enabling extended antigen phenotyping for use with the Ortho Vision analyzer
Cleveland Diagnostics Breakthrough device designation for blood-based prostate cancer test that evaluates structural changes to prostate-specific antigen (PSA) rather than just measuring the level of the biomarker a la traditional PSA tests
OraSure Technologies Clearance for OraQuick Ebola Rapid Antigen Test, first US-approved rapid detection test for Ebola virus
BioMérieux Clearance for ETest Eravacycline assay for determining antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria
Philips Electronics received 510(k) clearance for Philips IntelliSite Pathology Solution (PIPS) with a modified display
Binding Site Group Clearance for Human IgA liquid reagent kit for use on firm’s Spaplus turbidimetric analyzer
Qingdao Hightop Biotech Clearance for Pregnancy Rapid Test to measure human chorionic gonadotropin (hCG) in early pregnancy detection
Bioeasy Biotechnology Clearance for Bioeasy Marijuana Test Dip Card and Bioeasy Marijuana Test Strip lateral flow immunochromatographic assays for preliminary detection of marijuana in urine
Beckman Coulter Clearance for FC 500 MPL and MCL flow cytometers to measure biological and physical properties of cells and other particles as they pass through laser beams in a single file
Beckman Coulter 510(k) clearance for DxA 5000 total laboratory automation solution
Sekisui Diagnostics 510(k) clearance for Acucy Influenza A&B test + CLIA waiver for use on the Acucy Reader
Exact Sciences Expanded clearance for Cologuard DNA-based colorectal cancer screening test in average-risk people age 45 and older (as opposed to previous clearance for people age 50 and over)
Cepheid Clearance for Xpert BCR-ABL Ultra test for monitoring disease burden in patients with chronic myeloid leukemia
Luminex 510(k) clearance for real-time PCR-based Aries MRSA Assay running on firm’s Aries sample-to-answer system
Abbott Clearance for Architect Stat highly sensitive troponin blood test for more rapid detection of heart attacks
Bühlmann Laboratories 510(k) clearance for Calex Cap fecal extraction device for use with firm’s fecal calprotectin test

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:


Manufacturer(s) Product(s)
CE marking for APAS Independence automated culture plate reader
HemoSonics CE marking for QStat Cartridge, allowing Quantra Hemostasis System to be used in hospital trauma surgery and liver transplants
LumaCyte CE marking for Radiance label-free, single-cell analysis instrument
SpeeDx CE-IVD marking for ResistancePlus MG Flexible cartridge to test for sexually transmitted infection Mycoplasma genitalium and antibacterial resistance determination on Cepheid FleXible cartridge
Saladax Biomedical CE marking for use of MyCare Insite Clozapine Test to treat and monitor patients with schizophrenia
Sphingotec CE-IVD marking for IB10 Sphingotec DPP3 test for dipeptidyl peptidase 3
Roche CE marking for atezolizumab (Roche’s Tecentriq) in combination with chemotherapy for patients with PD-L1-positive, unresectable, locally advanced triple-negative breast cancer
Roche CE marking for Ventana PD-L1 (SP142) Assay for patients with PD-L1-positive, unresectable, locally advanced triple-negative breast cancer
Systaaq Diagnostic Products CE-IVD marking for SuperExtract 32, and viral nucleic acid extraction kit

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Cytek Biosciences China National Medical Products Administration approval for Cytek Northern Lights flow cytometer
Biomerica Colombia Ministry of Health and Social Protection Institute National Surveillance of Drugs and Food approval for EZ Detect colorectal screening test

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