The Food and Drug Administration (FDA) has granted de novo marketing authorization to the Invitae Common Hereditary Cancers panel, an in vitro diagnostic test that detects hundreds of genetic variants associated with an elevated risk of developing certain cancers.

The test — the first of its kind to be granted FDA authorization — also identifies potentially oncogenic hereditary variants in 47 genes in individuals diagnosed with cancer. The FDA reviewed the test under its de novo premarket review pathway for new types of low- to moderate-risk devices.

The test covers clinically significant genes including the breast and ovarian cancer-associated BRCA1 and BRCA2; Lynch syndrome-associated MLH1, MSH2, MSH6, PMS2, and EPCAM; hereditary diffuse gastric and lobular breast cancer-associated CDH1; and Peutz-Jeghers Syndrome-associated STK11.

Invitae bases clinical interpretation of variants on evidence from published literature, public databases, prediction programs, and the company’s internal curated variants database using its variant interpretation criteria, which is consistent with those established by appropriate professional organizations or accredited boards.

Along with this de novo authorization, the FDA also is establishing special controls that define requirements related to labeling and performance testing. These new requirements pertain to accuracy for reporting of substitutions, insertions and deletions, and copy number variants. These controls and requirements create a new regulatory classification, meaning subsequent devices of the same type as Invitae’s panel with the same intended use may go through the FDA’s 510(k) premarket process.

ADENO-ASSOCIATED VIRUS TEST GETS FDA BREAKTHROUGH DESIGNATION

Quest Diagnostics has received Breakthrough Device Designation from the Food and Drug Administration for its AAVrh74 ELISA assay.

The enzyme-linked immunosorbent in vitro diagnostic assay is intended for the semiquantitative detection in human serum of IgG antibodies to the capsid of the adeno-associated virus (AAV) vector AAVrh74. The test is intended to be used in conjunction with other available clinical information to help identify patients eligible for treatment with Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy developed by Sarepta Therapeutics for certain individuals with Duchenne muscular dystrophy.

Additionally, Quest and Sarepta announced an expanded collaboration under which Quest will develop companion or complementary diagnostics in connection with Sarepta’s portfolio of investigational and on-market gene therapies. The collaboration may encompass screening assays for antibodies to Sarepta’s other AAV vector-based gene therapies for muscular dystrophies, including Duchenne muscular dystrophy and limb girdle muscular dystrophies.

FDA APPROVES FOUNDATIONONE COMPANION DIAGNOSTICS FOR NEW INDICATIONS

The Food and Drug Administration (FDA) has approved FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.

The company also announced FDA approval for its FoundationOne CDx test as a companion diagnostic for Retevmo (selpercatinib). This drug is approved by the agency for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion who have either had prior systemic treatment, have no satisfactory alternative treatment options, or whose tumors have progressed on.

Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes in a tumor. The test has more than 30 companion diagnostic indications. Using a blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes and has several companion diagnostic indications.

NEW YORK STATE APPROVES UTI TEST

Pathnostics has earned approval from the New York State Department of Health (NYSDOH) for its urinary tract infection (UTI) test, Guidance UTI. The approval broadens patient access to the test, which enables rapid diagnosis and treatment of complicated, recurrent, and persistent UTIs.

According to Pathnostics, the test is the only NYSDOH-approved UTI test that uses molecular technology to identify organisms and resistance genes combined with pooled antibiotic susceptibility results. It delivers results less than a day after samples are received, compared with standard urine culture testing, which can take up to 5 days to produce results. The company added that its test has higher diagnostic specificity and sensitivity than standard testing and can identify specific uropathogens even when multiple organisms are present. Multiple studies show the test significantly reduces patient hospitalizations, emergency and urgent care visits, and empiric therapy rates.

RAS MUTATION KIT APPROVED AS COMPANION DIAGNOSTIC FOR VECTIBIX

The Food and Drug Administration has granted premarket approval to EntroGen’s CRCdx RAS Mutation Detection kit as a companion diagnostic for Vectibix (panitumumab), a targeted therapy used in the treatment of colorectal cancer.

According to the company, CRCdx is the first real-time PCR-based test approved in the U.S. that fully meets the biomarker identification requirement for Vectibix.

The kit detects KRAS and NRAS exon 2, 3, and 4 mutations with high sensitivity and specificity in colorectal cancer patients. This enables clinicians to identify patients most likely to benefit from Vectibix therapy and avoid unnecessary side effects and costs from treatment.

Company officials added that they hope the test will improve small and mid-size laboratories’ access to RAS testing by simplifying the process and lowering costs.

LUNG CANCER MUTATIONAL BURDEN TEST GETS CHINESE APPROVAL

Geneseeq Technology has announced that its Non-Small Cell Lung Cancer (NSCLC) Tumor Mutational Burden (TMB) test kit has gained approval from the Chinese National Medical Products Administration (NMPA) as a breakthrough medical device.

NMPA’s approval allows use of the kit for qualitative detection of TMB in formalin-fixed paraffin-embedded tissue samples from patients with EGFR/ALK-negative non-squamous NSCLC. The test covers 425 cancer-associated genes.

Company officials said the approval will “benefit the clinical implementation of immunotherapy in China with a standardized TMB assessment assay.”