For Next-Generation Sequencing, Election Result May Presage Positive Regulatory Developments

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Dec 07, 2016, 10:29 ET

ROCKVILLE, Md., Dec. 7, 2016 /PRNewswire/ -- Healthcare market research firm Kalorama Information believes the recent election in the United States could trigger improvements in regulatory developments for DNA sequencing. The healthcare market research firm says that pressure was increasing on the FDA to definite its plans on lab-developed testing, a key application area for NGS. Recent regulatory decisions were already indicating a more positive pathway for test developments. The incoming administration could be expected to pursue a less restrictive path. Kalorama Information covers the next-generation sequencing market in its report, Next-Generation Sequencing Markets.

Find the report at: http://www.kaloramainformation.com/Generation-Sequencing-Systems-10290041/.

"The uncertainty regarding the regulation of clinical applications of NGS has already not prevented the market from growing at an exceptional rate," said Bruce Carlson, Publisher of Kalorama Information.

NGS tests have been largely run as LDTs in a CLIA regulated setting, partly because none of the systems were FDA-cleared until the last couple of years. The industry sought work-arounds in the form of research-use-only (RUO) products for diagnostics. This has been a grey area in need of more specific, but not necessarily restrictive, guidelines for some time, and medical organizations have been gradually addressing the new tests, making recommendations and determining the amounts to be reimbursed.

The following provides some highlights of the recent regulatory developments in reverse chronological order:

In September 2016, Vela Diagnostics announced that the Chinese FDA (CFDA) granted the Class I Medical Device status to the Sentosa SX 101 instrument for clinical use. The multi-purpose automated liquid handling platform plays a key role in the Sentosa PCR and NGS workflow by providing walk-away automation for labor-intensive sample preparation. The company also received Emergency Use Authorization (EUA) from the US FDA for its Sentosa SA ZIKV RT-PCR Test, a real-time PCR test for qualitative detection of RNA from Zika virus in human specimens available for use by labs in the U.S. that are certified under CLIA to perform high complexity tests or similarly qualified non-U.S. labs.
In July 2016, Asuragen announced that it received premarket clearance from the US FDA for the QuantideX qPCR BCR-ABL IS Kit for the monitoring of molecular response in Chronic Myeloid Leukemia (CML) patients.
In July 2016, HTG Molecular Diagnostics received CE-IVD marking for its HTG EdgeSeq DLBCL Cell of Origin Assay and the NGS-based HTG EdgeSeq system. The HTG EdgeSeq DLBCL Cell of Origin Assay uses gene expression profiling to determine the cell of origin subtype of DLBCL tumors from formalin fixed paraffin embedded (FFPE) tissue.
In July 2016, Pangaea Biotech announced that it was accredited by Spain's National Accreditation Body ENAC for its tests for tissue, blood serum, and plasma analyzing KRAS (codons 12-13), BRAF (V600E), and EGFR (exons 19, 20 (T790M), and 21).
In June 2016, Roche Molecular Systems received FDA approval for the cobas EFGR Mutation Test v2 using blood plasma specimens for a companion diagnostic test for the detection of exon 19 deletions or exon 21 (L858R) substitution mutations in the epidermal growth factor recptor (EGFR) gene, to identify patients with metastatic non-small cell lung cancer (NSCLC) eligible for treatment with Tarceva (erlotinib).
In June 2016, Vela Diagnostics' Sentosa SQ HCV Genotyping Assay was CE marked for IVD use and certified to meet the requirements of EC IVD Directive 98/79/EC Annex II List A for high-risk IVD products.
In April 2016, Epigenomics received FDA approval for the Epi proColon, a blood-based colorectal cancer screening test indicated for average-risk patients who choose not to screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests (FIT).
In April 2016, Sysmex Inostics and Merck KGaA received the CE mark for their jointly-developed OncoBEAM RAS CRC, a blood-based test for patients with metastatic colorectal cancer (mCRC).

Kalorama Information's Next Generation Sequencing Markets report contains more developments as well as estimates and forecasts of the market. The publisher plans a report on cfDNA markets this month.

Please link any media or news references to our reports or data to http://www.kaloramainformation.com/.

About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog on our company website.

Press Contact:
Bruce Carlson
212 807 2262
[email protected]

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SOURCE Kalorama Information