A newly developed at-home fertility test, Inito, has launched on the U.S. market. The test aims to help users better understand hormone and ovulation information. The monitoring device can be paired with a smartphone app for quick access to data.

Inito works by measuring hormone values for estrogen and luteinizing hormone levels to predict fertile days, then measuring progesterone to confirm ovulation, ultimately assisting patients through the conception process. The test requires a patient to dip a strip into urine, attach the monitor to a smartphone, insert the strip into the monitor, then review results on the app. Compared with to traditional ovulation tests currently on the market, Inito says it can provide detailed and more accurate results with faster turnaround times.

According to the company, Inito has the ability to customize to a patient’s unique hormone levels to better work with regular and irregular menstrual cycles, identify six fertile days in a patient’s cycle, and even remind a patient when to test based on personalized hormone variations.

In addition to the launch of the device, Inito also is introducing a feature in the app titled Hormone Charts for users to better understand their hormone levels and to have the option to share the data with their doctor.

“Abnormalities such as frequent anovulatory cycles, shorter luteal phase, and low levels of progesterone can easily go unnoticed without monitoring with expensive and invasive lab tests,” said Kim Langdon, MD, advisor to Inito.

“We started Inito to provide couples with a more accurate look at what’s happening with their unique cycle and actionable data to help them get pregnant faster,” added Varun AV, cofounder of Inito.

Currently, Inito has collected over 1 million hormone values from patients in Asia.

Qiagen, Verogen Partner for NGS and HID Solutions

Aiming to improve human identification (HID) workflows in laboratories, Qiagen and Verogen have teamed up to advance the use of next-generation sequencing (NGS) in the forensics field. Through the partnership, Qiagen will expand its established work in the forensics market while also commercializing Verogen’s sequencing and analysis products for HID.

Currently, Qiagen’s work in forensics focuses on sample collection and preparation, genetic testing analysis, and workflow automation. By obtaining the rights to Verogen’s HID solutions, Qiagen will not only broaden its portfolio but will also expand the reach of Verogen’s lineup, which includes the Verogen ForenSeq assay, the Verogen MiSeq FGx Sequencing System, and its Universal Analysis Software. Both partners also plan to develop a menu of forensically validated workflows for NGS that combine Verogen’s library-prep products with Qiagen’s QIAseq products, automation solutions, and expertise.

"This partnership with Qiagen will make it easier for laboratories to provide more impactful answers. By combining Verogen’s industry-leading NGS-based product portfolio with Qiagen’s gold-standard extraction, assay, and automation solutions, we will accelerate adoption and use of NGS in forensics,” said Brett Williams, CEO of Verogen.

Thermo Fisher Launches Raw Saliva Testing Kit for SARS-CoV-2

To improve research on and surveillance of SARS-CoV-2, Thermo Fisher Scientific announced their newly developed testing kit, SpeciMAX Saliva Collection Kit.

Thermo Fisher describes the SpeciMAX Saliva Collection Kit as an easy-to-use self-collection kit designed to provide a widely available, cost-effective solution for raw saliva collection. According to Thermo Fisher, each kit delivers clean saliva transfers, reduces the risk of cross-contamination when paired with liquid handlers, and fits seamlessly into viral RNA extraction and direct-to-PCR downstream automation workflows for high throughput surveillance testing.

With SpeciMAX, labs will be able to capture raw saliva with minimal workflow disruption and minimal manual processing, enabling more efficient SARS-CoV-2 research and surveillance," said Ellie Mahjubi, vice president and general manager of sample preparation at Thermo Fisher Scientific.

Each kit includes one barcoded collection tube, a funnel, and a cap, and requires only 1 mL of saliva, as well as less refrigeration, incubation, and storage space than other collection kits currently on the market.

LightDeck Receives $35.1 Million in Funding From DOD

In collaboration with the Department of Health and Human Services (HHS), the Department of Defense (DOD) awarded a $35.1 million contract to LightDeck Diagnostics to increase its manufacturing capacity in its Colorado production facility.

The DOD specifically granted the funding for LightDeck’s COVID-19 Ultra-Rapid Antigen and Total Antibody tests, which are are currently being developed for regulatory approval. According to LightDeck, its multiplex waveguide immunoassay platform has the ability to return results in just 5 minutes due to the special laser-based technology that enables rapid signal development and reduces background noise that could cause interference. LightDeck plans to market both the platform and testing assays to healthcare facilities across the U.S. before expanding to a worldwide network. Its target settings include traditional healthcare facilities as well as nontraditional environments such as prisons. With the awarded money, the parties expect LightDeck to be able to produce 1 million tests per month, as opposed to its current limit of 50,000 tests per month.

Twist Bioscience Acquires iGenomX for $35 Million

Twist Bioscience, a synthetic biology and genomics company, announced acquisition of iGenomX, a company offering multiplex library preparation tools for next-generation sequencing (NGS) workflows.

Twist CEO Emily Leproust said that the acquisition of iGenomX will allow customers to convert from single nucleotide polymorphism microarray to an NGS-based approach.
“The iGenomX team built a robust PCR-like workflow for ultra-high throughput library construction,” Leproust said. “We anticipate this technology, together with our leading NGS product line and worldwide commercial infrastructure, will drive adoption of Twist NGS workflow solutions into fields that run large volumes of samples with shallow sequencing."

According to Twist, using an NGS-based approach will be more cost-effective and allow for customization with iGenomX’s automated library prep system.

The $35 million deal includes an initial $500,000 cash payment and $29.5 million in Twist stock. The agreement also includes an additional $5 million in Twist shares if certain milestones are met starting 6 months after the close of the deal.