Pillar Biosciences Files IPO Prospectus Highlighting AI-Powered Same-Day NGS Tests and FDA-Approved Lung & Colorectal Cancer Dx Kits

NGS (Next-Generation Sequencing), also known as high-throughput sequencing technology.It is currently widely used for genetic disease screening, prenatal testing or diagnosis, clinical tumor diagnosis, pharmacogenomic testing, cancer chemotherapy and treatment, and single-gene disease screening or diagnosis. It enables parallel sequencing of hundreds of thousands to millions of DNA molecules in a single run, offering rapid analysis, high accuracy, and short turnaround time.

Currently, the clinical objectives of NGS testing are twofold: one is to evaluate the suitability of immunotherapies or targeted therapies; the other is to test patients with a family history of hereditary tumors, as well as their parents or close relatives, to identify the specific type of hereditary disease, determine whether relatives carry pathogenic variants, assess the risk of disease onset, and evaluate reproductive risks.

Pillar Biosciences is a global company providing precision oncology diagnostic solutions, but its NGS testing is independent of the NGS testing platform.The company has developed SLIMamp using AI technology.^®and PiVAT^®, reducing the turnaround time for traditional NGS testing from several days to just one day, while requiring less DNA input and delivering reliable results even with compromised samples.

Pillar Biosciences, headquartered in Natick, Massachusetts, USA, was co-founded by Dr. Gang Song and Dr. Zhaohui Wang in 2014.Dr. Song earned his Ph.D. from Shanghai Medical College of Fudan University and completed his postdoctoral training in the laboratory of Timothy Springer at Harvard Medical School. Dr. Wang Zhaohui graduated with a degree in Cellular and Molecular Biology from the University of Massachusetts Amherst.

The two doctors previously worked together at LabCorp (formerly Genzyme Genetics) and IQuum (later acquired by Roche Molecular Diagnostics), and subsequentlyCo-invented SLIMamp^®Technology, Pillar Biosciences was thus established. Currently,Dr. Wang Zhaohui serves as the company's Chief Scientific Officer.。

Mr. Randy Pritchard, Chief Executive OfficerHolds an MBA from Indiana Wesleyan University and has over 24 years of experience in the healthcare industry. He has served as Senior Vice President of Marketing at Diagnostic Corporation of America, Senior Vice President and Head of Lifecycle for the POC Diagnostics and Core Reagents division, and Vice President of Marketing for Roche Diagnostics’ Centralized Diagnostics business.

Co-Founder and Chief Scientific Officer, Dr. Chaohui Wang Chief Executive Officer, Randy Pritchard

The seed-round investment in the company, founded by two Chinese nationals, also came from a Chinese healthcare investment firm—ZhenFund, totaling RMB 1 million. The company subsequently received investments from institutions such as ORI Capital and ORI Healthcare Fund, bringing its cumulative fundraising to over USD 65 million.

Pillar Biosciences Funding Summary (Data Source: Crunchbase)

To deliver accurate, sensitive, rapid, and cost-effective precision IVD solutions, Pillar Biosciences has developed AI-designed primers (ampPD) and PCR amplification design (SLIMamp).^®and the intelligent biochemical information automated sharing platform, PiVAT^®Three Technologies and Products.

ampPD uses artificial intelligence (AI) technology to design primers that bind to specific genes required for PCR amplification., and bind to mutant genes, making it possible to develop personalized diagnostics and therapeutics targeting specific genes associated with an individual’s unique cancer.

After primer design is completed and the primers are annealed to the mutant gene, PCR amplification is required. Pillar Biosciences’ PCR amplification technology is called SLIMamp.^®, is a chemical method that can complete gene amplification in a single test tube.SLIMamp^®Employing single-tube multiplexing, the process involves one 3-hour amplification and one 1-hour exponential amplification, with a 30-minute purification step performed after each amplification. This method completes the entire DNA amplification in a cumulative 5 hours, reducing the time required by half compared to other methods.

SLIMamp^®Single-tube multiplexing more accurately reflects amplicons than traditional multiplexing

Following DNA amplification, gene detection will be performed using the PiVAT results processing platform.^®It can rapidly provide physicians with reliable analytical results, facilitating faster decision-making on treatment plans. Upon obtaining FASTQ data, BAM files are generated by aligning the data against the patient’s personal genome.Pillar Biosciences re-filters, sorts, and layouts the data to generate Pillar BAM (PBAM) files., thereby enabling the identification of SNV, CNV, and fusion variants. The final output includes a data summary table and a VCF file containing variants in HGVS format.PBAM reduces sorting errors, so even for damaged samples, PiVAT^®It can also provide reliable results.

October 15, 2020PieriaNdx, a Clinical Genomics Informatics CompanyPartnering with Pillar Biosciences enables PiVAT^®The processed PierianDx clinical genomic reports and their cancer analysis reports can be sold directly through Pillar Biosciences.

Accurate Allele Frequency Detection from Damaged FFPE Samples

Pillar Biosciences employs an NGS workflow rather than relying on an NGS platform., resulting in an NGS assay with simplified steps and significantly reduced turnaround time, named the oncoReveal assay. Validation experiments by Pillar Biosciences have demonstrated that this technology exhibits a very high correlation with conventional assays, R²=0.9336。

Ph.D. holders from Harvard Medical School form the Scientific Advisory Board of Pillar Biosciences, developing through the oncoReveal assayNGS Panel for 10 Tumor Markers, including lung cancer, colorectal cancer, breast cancer, myeloproliferative neoplasms (MPN), and some multiple primary cancers.

On August 5, 2021, Pillar Biosciences announced that the FDA had granted its oncoReveal^TMDx Lung Cancer and Colon Cancer Detection (O/R Dx-LCCA) Kit Issued PMA.O/RDx-LCCA utilizes amplicon target enrichment technology on the Illumina MiSeqDx instrument to detect single nucleotide variants (SNVs) and two gene deletions in tumor tissue specimens isolated from formalin-fixed, paraffin-embedded (FFPE) samples of non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

Specifically, oRDx-LCCA uses SLIMamp^®(Dry-Ring Inhibition-Mediated Amplification) technology is used to amplify target regions containing mutation hotspots, preparing sample DNA for sequencing. Subsequently, sequencing is performed using the Illumina® MiSeqDx® instrument, and PiVAT is employed^®(Pillar Variant Analysis Toolkit) software analyzes, quantifies, and reports genetic variants present in sample sequences. PiVAT^®It involves secondary analysis of the FASTQ files for each sample, primarily including alignment, paired-end assembly, variant calling, and report generation.

Somatic Variants Targeted by oRDx-LCCA for Treatment

oRDx-LCCA is designed to detect and report somatic variants, including EGFR exon 19 deletions; EGFR L858R mutations; KRAS G12 and KRAS G12 missense mutations; and KRAS G12 and KRAS G13 missense mutations. It does not include non-targeted variants or germline variants.

On October 14 of the same year,Life Sciences Company Labcorp(NYSE:LH)Strategic Partnership Agreement Reached with Pillar Biosciences, both parties will collaborate on oncoReveal^TMCollaborate on the EssentialMPN Panel testing project to bring broader market opportunities to Pillar.

Currently, Pillar Biosciences’ technologies and products are primarily provided toBenchmark Laboratory、Specialized Laboratory、Pharmaceutical/Biotech Research、Academic Health System or Community Health System. The company hopes to generate actionable insights by leveraging data-driven approaches,Implementing targeted NGS testing enables more NGS laboratories to establish simplified, accurate, rapid, and cost-effective workflows and result reporting.。

Pillar Biosciences currently has four distributors: iNTRON, Tarom Applied Technologies LTD., Genique Lifesciences, and ALBIOGEN.In addition to its U.S. headquarters, the company has established a subsidiary in Shanghai, China—Zhengu Biology.

ZhenGu Bio is located in Xuhui District, Shanghai. It has established its business development and sales center at the Juke Biological Park in Xuhui District, and founded its China Technology Transfer and R&D Center at the Juke Fengchuang Valley Base in Fengxian District., successfully achieving the domestic translation and localized application development of the international gene sequencing technology system; meanwhile, it rapidly initiated the registration of tumor NGS sequencing IVD products and the construction of a clinical laboratory service system, and has now established a 2,000-square-meter GMP manufacturing facility. Its affiliated clinical laboratory center, “Zhengu Medicine,” has obtained Class III medical device registration certificates and is comprehensively deploying nationwide product sales and high-end testing services.